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Site Care Partner (Sponsor dedicated) - Buenos Aires only - Min 6+ years of previous monitoring experience, ideally in Oncology!
サイネオス・ヘルス

Remote Argentina

Updated Yesterday Location Remote B Argentina Job ID 25112421 Not ready to apply? Join our Talent Network Description Site Care Partner (Sponsor dedicated) - Buenos Aires only - Min 6+ years of previous monitoring experience ideally in Oncology! Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together as one team each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life. Discover what our 29000 employees across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts backgrounds cultures and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Performs site qualification site initiation interim monitoring site management and close-out visits (performed on-site or remotely) ensuring regulatory ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance relevant regulations and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP)Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records Applies query resolution techniques remotely and on site and provides guidance to site staff as necessary driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. May perform investigational product (IP) inventory reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters follow-up letters trip reports communication logs and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment retention and awareness strategies. Enters data into tracking systems as required to track all observations ongoing status and action items to resolution. Understands project scope budgets and timelines for own and others’ activities in the clinical team manages site-level activities / communication to ensure project objectives deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. May provide direct supervision training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff as assigned. May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings. For Real World Late Phase (RWLP) the Sr. CRA II will use the business card title of Sr.Site Management Associate II. Additional responsibilities include Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs Chart abstraction activities and data collection As required collaborate and build relationship with Sponsor and other affiliates medical science liaisons and local country staff The SMA II may be requested to train junior staff Identify and communicate out of scope activities to Lead CRA/Project Manager Proactively suggest potential sites based on local knowledge of treatment patterns patient advocacy and Health Care Provider (HCP) associations. Identify operational efficiencies and process improvements Develop study and country level informed consent forms Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared Participate in bid defense meetings Provide input into Requests for Proposals (RFPs) scope and budgeting. Develop site management strategy. Participate in Case Report Form design and edit check development. Qualifications Bachelor’s degree or RN in a related field or equivalent combination of education training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication presentation and interpersonal skills. Moderate level of critical thinking skills expected. Ability to manage required travel of up to 75% on a regular basis We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest you'll be added to our talent pipeline and considered should this role become available. Get to know Syneos Health Over the past 5 years we have worked with 94% of all Novel FDA Approved Drugs 95% of EMA Authorized Products and over 200 Studies across 73000 Sites and 675000+ Trial patients. No matter what your role is you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http//www.syneoshealth.com Additional Information Tasks duties and responsibilities as listed in this job description are not exhaustive. The Company at its sole discretion and with no prior notice may assign other tasks duties and job responsibilities. Equivalent experience skills and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company at its sole discretion will determine what constitutes as equivalent to the qualifications described above. Further nothing contained herein should be construed to create an employment contract. Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates including the implementation of the EU Equality Directive in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act including the provision of reasonable accommodations when appropriate to assist employees or applicants to perform the essential functions of the job. Summary Roles within Clinical Monitoring/CRA job family are responsible for monitoring during clinical research studies to ensure that the trials are being conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring developing tools procedures and processes to ensure quality monitoring. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design implementation or delivery of processes programs and policies using knowledge and skills typically acquired through advanced education. Individual contributor with developing subject matter expertise and responsibility for processes. In-depth knowledge and skills within a professional discipline understanding the impact of work on related areas. May be responsible for entire projects or processes within area of responsibility.

New 8 min(s). ago 🔥 View
Regulatory Labeling Manager
サイネオス・ヘルス

Remote Argentina

Updated Yesterday Location Remote B Argentina Job ID 25112148 Not ready to apply? Join our Talent Network Description Regulatory Labeling Manager Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together as one team each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life. Discover what our 29000 employees across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts backgrounds cultures and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities The Regulatory Labeling Manager – Lifecycle Products is responsible for the development maintenance and oversight of labeling content for mature pharmaceutical products (product that have no additional development activities ongoing). This role involves authoring and updating labeling documents in response to safety updates regulatory requirements and internal assessments. The manager collaborates with internal stakeholders to ensure governance processes are followed and labeling decisions are well-documented in accordance with Vertex’s Labeling Procedures. Key Responsibilities Plan and lead labeling updates driven by safety changes regulatory commitments and periodic reviews. Author and revise labeling documents including the Company Core Data Sheets (CCDSs) US Prescribing Information (USPI) EU Summary of Product Characteristics (SmPC) and Rest of World (ROW) labels for lifecycle products. Support labeling governance activities by collaborating with the team lead and GLL/RLL to prepare materials attend the governance meeting and record accurate minutes in a timely manner to upload in the electronic document management system and ensure required approvals are obtained. Ensure labeling content complies with applicable regulatory requirements (e.g. FDA EMA ICH) and internal standards. Collaborate with cross-functional teams (e.g. Safety Medical Legal Regulatory Strategy) to gather input and align on labeling changes as needed. Support responses to health authority queries related to labeling content. Partner with document specialists and publishing teams to ensure submission-ready formatting and timely delivery. Attend labeling governance meetings and draft accurate minutes in a timely manner. Upload minutes to the electronic document management system. Required Knowledge/Skills Strong understanding of global labeling regulations and guidance (FDA EMA ICH). Proven experience authoring and maintaining labeling content for approved products. A strong command of English language including grammar spelling and punctuation and exceptional proofreading and editing skills. Strong organizational skills and attention to detail. Proficiency in Microsoft Word and document management systems (e.g. Veeva Vault). Experience using Label tracking systems e.g. Intagras Veeva Labeling. Ability to communicate and work effectively with labeling stakeholders. Required Experience & Education Level Experience supporting labeling negotiations with health authorities. Knowledge of safety data interpretation and its impact on labeling. Familiarity with structured content authoring tools or XML-based labeling systems. Experience preparing labeling components for eCTD submissions. Typically 2+ years of experience in the biotechnology industry preferably in Regulatory Affairs Regulatory Labeling or a related discipline Minimum Bachelor's degree in a Science or Business-related field We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest you'll be added to our talent pipeline and considered should this role become available. Get to know Syneos Health Over the past 5 years we have worked with 94% of all Novel FDA Approved Drugs 95% of EMA Authorized Products and over 200 Studies across 73000 Sites and 675000+ Trial patients. No matter what your role is you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http//www.syneoshealth.com Additional Information Tasks duties and responsibilities as listed in this job description are not exhaustive. The Company at its sole discretion and with no prior notice may assign other tasks duties and job responsibilities. Equivalent experience skills and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company at its sole discretion will determine what constitutes as equivalent to the qualifications described above. Further nothing contained herein should be construed to create an employment contract. Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates including the implementation of the EU Equality Directive in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act including the provision of reasonable accommodations when appropriate to assist employees or applicants to perform the essential functions of the job.

New 8 min(s). ago 🔥 View
Mobility Specialist
Remote

Remote Argentina

About Remote Remote is solving modern organizations' biggest challenge – navigating global employment compliantly with ease. We make it possible for businesses of all sizes to recruit pay and manage international teams. With our core values at heart and future focused work culture our team works tirelessly on ambitious problems asynchronously around the world. You can find Remoters working from 6 different continents (Antarctica left to go!) and all of our positions are fully remote. With Innovation as one of the core values we have built Automation and AI capabilities into the requirements for every role. We encourage every member of the Remote team to bring their talents experiences and culture to the table to help us build the best-in-class HR platform. If you are energetic curious motivated and ambitious be part of our world. Apply now and define the future of work! The Mobility team embodies Remote's dedication to building a worldwide talent community. They ensure employees transition smoothly across borders adhering to local laws and provide extensive immigration and relocation assistance. This allows Remote and its clients to secure top global talent and their commitment to risk management and clear stakeholder communication is commendable. They improve processes for compliance in remote work and business travel keeping Remote at the global mobility forefront. Their collaborative approach with vendors and focus on top-notch relocation logistics guarantee seamless transitions for Remote employees enhancing Remote's global mobility programs and affirming its leadership in the global talent market. Join Remote at a pivotal time and contribute significantly as a Mobility Specialist within our Onboarding and Mobility team. This role offers the unique opportunity to impact the global employment landscape directly. Requirements Proven experience in immigration compliance global mobility or similar roles particularly with a focus on immigration A comprehensive understanding of immigration procedures and the typical processes involved in ensuring immigration compliance Ability to thrive in a fast-paced and dynamic work environment Ability to demonstrate composure and efficiency under pressure maintaining high-performance standards during seasons of increased workloads Experience in the technology sector or a company undergoing rapid growth and scaling is highly desirable Flexible and adaptable team player who can seamlessly shift in response to evolving priorities or changing processes Demonstrated customer-facing experience with a strong emphasis on communication skills and the ability to engage effectively with diverse client bases A strong interest in expanding knowledge of global immigration laws eager to develop expertise. Experience working remotely and/or asynchronously with minimal oversight is an advantage Must write and speak English fluently (additional languages are a plus) Key Responsibilities Provide legal and strategic guidance to clients on immigration compliance service delivery. Monitor and control Remote products and services for immigration compliance. Establish maintain and strengthen relationships with clients and internal stakeholders. Seek control and establish in-house immigration services to increase revenue generation efficiency and customer satisfaction. + Analyze prepare and submit visa/work permit applications. Independently maintain and monitor immigration law ensuring ongoing compliance with regulatory changes and control internal documentation. Appropriately handle escalations analyze when the senior-level review is required determine solutions and guide stakeholders to a timely resolution. Guide for specific travel needs counsel on the immigration process and serve as a point of contact for business travel and sponsorship cases. Control case statuses by effectively utilizing case management and billing systems. Apply immigration knowledge to provide solution-based responses when dealing with complex client cases. Be a team player who can work autonomously and take ownership of day-to-day tasks. Proactively improve processes through automation and documentation. Practicals You'll report to Manager Mobility Team Mobility Location LAMER Start date As soon as possible Application process - Profile review Interview with recruiter Interview with Manager of Mobility Operations Team interview Bar Raiser interview Prior employment verification check(s) Benefits Our full benefits & perks are explained in our handbook at remote.com/r/benefits. As a global company each country works differently but some benefits/perks are for all Remoters work from anywhere flexible paid time off flexible working hours (we are async) 16 weeks paid parental leave budget towards co-working spaces learning and wellness (including gym memberships) mental health support services stock options home office budget & IT equipment How you'll plan your day (and life) - We work async at Remote which means you can plan your schedule around your life (and not around meetings). Read more at remote.com/async. You will be empowered to take ownership and be proactive. When in doubt you will default to action instead of waiting. Your life-work balance is important and you will be encouraged to put yourself and your family first and fit work around your needs. If that sounds like something you want apply now! How to apply Please fill out the form below and upload your CV with a PDF format. We kindly ask you to submit your application and CV in English as this is the standardised language we use here at Remote. If you don't have an up to date CV but you are still interested in talking to us please feel free to add a copy of your LinkedIn profile instead. Not only do we encourage folks from all ethnic groups genders sexuality age abilities disability status and any other under-represented group to apply but we prioritize a sense of belonging. We have 4 ERGs (Women Disability Queer Minorities in Tech) who meet regularly with the People team. During your interviews and beyond we ask & encourage anybody who needs an accommodation to request one from their recruiter. We will ask you to voluntarily tell us your pronouns at interview stage and you will have the option to answer our anonymous demographic questionnaire when you apply below. As an equal employment opportunity employer it's important to us that our workforce reflects people of all backgrounds identities and experiences and this data will help us to stay accountable. We thank you for providing this data if you chose to. At Remote we embrace AI as a valuable tool while prioritizing human creativity and authenticity. We look forward to meeting candidates who balance innovation with genuine expertise and experience. To learn more about Remote's AI guidelines check see here. Please note we accept applications on an ongoing basis.

New 8 min(s). ago 🔥 View
Corporate Paralegal (LATAM)
Backblaze

Remote Argentina

Corporate Paralegal About Backblaze Backblaze is a public company that makes storing and using data astonishingly easy. When our founding team got together they committed to helping people save their data. Today the Backblaze Storage Cloud provides a foundational platform around the world for a broad community of developers IT generalists entrepreneurs and individuals who seek the easy affordable trusted solutions we provide. We have managed to nurture a team-oriented culture with amazingly low turnover. Our approach is guided by honesty transparency and a commitment to doing the right thing. Our customers are happy and so are our coworkers in the most recent “Great Place to Work” survey 97% of our team rated Backblaze as “a great place to work.” Check out what our employees are saying on Glassdoor! About the Role We are seeking a Legal Paralegal to support Backblaze’s public-company corporate and governance operations. This role is the execution engine behind the Legal & Compliance team public-company filings board and committee preparation entity and governance records and litigation and insurance claims support. It frees attorney time and keeps a fast-moving public-company calendar running on schedule. The ideal candidate is exceptionally organized detail-oriented and comfortable handling confidential and market-sensitive information with discretion. This is a high-ownership role for someone who takes pride in accurate on-time execution and wants to grow with a lean high-impact team. This role reports to the Head of Legal & Compliance and is fully remote. What You’ll Do Public Company and Securities Support Support the preparation and filing of periodic and current reports including Forms 10-K 10-Q and 8-K. Coordinate filing logistics with internal stakeholders outside counsel auditors investor relations and financial printers or filing agents including EDGAR submission support exhibit management and filing-package assembly. Support Section 16 filings (Forms 3 4 and 5) including preparation review coordination and timely submission and help maintain the list of Section 16 insiders. Help administer the insider trading policy including trading-window and blackout tracking and support for the Rule 10b5-1 plans program. Prepare and administer D&O questionnaires and support related director and officer records. Assist with the annual proxy statement annual meeting logistics and related public-company activities. Support stock administration and equity matters including maintaining cap table and equity grant records and beneficial ownership data used in Section 16 and proxy reporting in coordination with Finance. Support Nasdaq listing compliance including listing notifications and related submissions. Board and Committee Support Prepare Board and committee meeting materials manage logistics and coordinate scheduling. Administer the board portal (for example Diligent or Boardvantage) including posting materials and managing director access. Draft and maintain minutes resolutions action items and follow-ups. Entity Management and Governance Records Maintain minute books resolutions and governance records for domestic and foreign entities. Support state and subsidiary filings annual reports good-standing maintenance and registered-agent coordination. Litigation and Insurance Claims Support Support litigation matters including document organization tracking and coordination with outside counsel. Track and administer insurance claims and related documentation. Prepare responses to subpoenas and legal process and coordinate collection and production of responsive materials. Cross-Functional Support AI and Administration Use AI tools and legal technology to streamline filing preparation records management and recurring workflows and help identify opportunities to work more efficiently. Partner with attorneys Legal Operations Finance and other teams to keep matters moving and deadlines met. Other duties as required from time to time. The Right Fit Highly organized and detail-oriented with a strong track record of managing deadline-driven filing and governance calendars. Experience as a corporate or public-company paralegal ideally supporting SEC filings Section 16 board preparation and entity management. Sound judgment and discretion in handling confidential and material non-public information. Experience supporting a Corporate Secretary Board of Directors and senior executives with sensitive market-moving materials. Proactive dependable and solutions-oriented with a strong sense of ownership and accountability. Comfort with AI tools and legal technology or a strong interest and eagerness to adopt them in a legal-support context. Clear communicator who works well with attorneys executives and cross-functional partners. Qualifications Minimum education Bachelor’s degree or an equivalent combination of education training and/or experience. Paralegal certificate from an ABA-approved program preferred. 8 or more years of corporate or public-company paralegal experience ideally including a combination of law firm and in-house experience. Working knowledge of SEC reporting requirements Section 16 and Nasdaq listing standards and public-company governance practices. Familiarity with public-company filing tools and processes (for example EDGAR XBRL and Section 16 filing agents) board portals (for example Diligent or Boardvantage) and entity management software. Experience supporting stock administration and equity plan records is a plus. Litigation insurance claims or subpoena and legal process support experience is a plus. Comfort using AI tools to work more efficiently or a genuine willingness to develop fluency in them. Experience at a public technology or SaaS company is a plus. At Backblaze we value being fair and good to our customers partners and employees. That is why diversity equity and inclusion are at the core of our values. We are committed to fostering a workforce where all employees feel a sense of belonging regardless of race ethnicity nationality gender sexual orientation age religion socioeconomic status ability veteran status and education. We believe that our dedication to cultivating a diverse workspace not only allows us to better serve our customers in over 175 countries but further reinforces our commitment to doing the right thing. We are proud to be an Equal Opportunity Employer.

New 8 min(s). ago 🔥 View
Site Care Partner (Sponsor dedicated) - Buenos Aires only - Min 6+ years of previous monitoring experience, ideally in Oncology!
Syneos Health

Remote Argentina

Site Care Partner (Sponsor dedicated) - Buenos Aires only - Min 6+ years of previous monitoring experience ideally in Oncology! Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together as one team each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life. Discover what our 29000 employees across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts backgrounds cultures and perspectives – we’re able to create a place where everyone feels like they belong. Job Responsibilities Performs site qualification site initiation interim monitoring site management and close-out visits (performed on-site or remotely) ensuring regulatory ICH-GCP and/or Good Pharmacoepidemiology Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance relevant regulations and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP)Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records Applies query resolution techniques remotely and on site and provides guidance to site staff as necessary driving query resolution to closure within agreed timelines Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. May perform investigational product (IP) inventory reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters follow-up letters trip reports communication logs and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment retention and awareness strategies. Enters data into tracking systems as required to track all observations ongoing status and action items to resolution. Understands project scope budgets and timelines for own and others’ activities in the clinical team manages site-level activities / communication to ensure project objectives deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with study site personnel or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in and may lead global clinical monitoring/project staff meetings (inclusive of Sponsor representation as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. May provide direct supervision training and/or mentorship to more junior level CRAs. Performs training and sign off visits for junior CRA staff as assigned. May be mentored and assigned lead tasks under supervision of an experienced Clinical Operations Lead (COL) or operational line manager. This could include participation in business development proposals and/or defense meetings. For Real World Late Phase (RWLP) the Sr. CRA II will use the business card title of Sr.Site Management Associate II. Additional responsibilities include Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs Chart abstraction activities and data collection As required collaborate and build relationship with Sponsor and other affiliates medical science liaisons and local country staff The SMA II may be requested to train junior staff Identify and communicate out of scope activities to Lead CRA/Project Manager Proactively suggest potential sites based on local knowledge of treatment patterns patient advocacy and Health Care Provider (HCP) associations. Identify operational efficiencies and process improvements Develop study and country level informed consent forms Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared Participate in bid defense meetings Provide input into Requests for Proposals (RFPs) scope and budgeting. Develop site management strategy. Participate in Case Report Form design and edit check development. Qualifications Bachelor’s degree or RN in a related field or equivalent combination of education training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication presentation and interpersonal skills. Moderate level of critical thinking skills expected. Ability to manage required travel of up to 75% on a regular basis We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest you'll be added to our talent pipeline and considered should this role become available. Get to know Syneos Health Over the past 5 years we have worked with 94% of all Novel FDA Approved Drugs 95% of EMA Authorized Products and over 200 Studies across 73000 Sites and 675000+ Trial patients. No matter what your role is you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http//www.syneoshealth.com Additional Information Tasks duties and responsibilities as listed in this job description are not exhaustive. The Company at its sole discretion and with no prior notice may assign other tasks duties and job responsibilities. Equivalent experience skills and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company at its sole discretion will determine what constitutes as equivalent to the qualifications described above. Further nothing contained herein should be construed to create an employment contract. Occasionally required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates including the implementation of the EU Equality Directive in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act including the provision of reasonable accommodations when appropriate to assist employees or applicants to perform the essential functions of the job.

New 8 min(s). ago 🔥 View

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