Job Title: Central CRA (Clinical Research Associate) - Registries
Hiring Manager: Project Lead – ESR and Grants
Location: Hyderabad, India
% of Travel Expected: Travel required as per business need
Job Type: Permanent and Full-Time
About Sanofi Business Operations (SBO)
Sanofi Business Operations (SBO) is an internal organization within Sanofi, designed to centralize various processes and activities to support different functions such as Specialty Care, Vaccines, General Medicines, and R&D, Data & Digital. SBO aims to reduce reliance on external service providers and build internal expertise, making it a strategic and functional partner for Sanofi's global operations.
Main Responsibilities
Feasibility and Study Start-up Activities
Site Selection and Feasibility: Collaborate with the Registries Team to support the site selection process.
Study Start-up: Assist in collecting site documents for submission to regulatory authorities (HA/RA) and Ethics Committees (EC/IRB).
Document Review: Ensure quality checks on site and study documents for submission and follow-up with EC/IRB for any additional queries.
Insurance Certificate and ICF Customization: Prepare necessary documents like Insurance Certificates and customize the Informed Consent Form (ICF) based on local regulations.
Site Contracting: Assist in site contracting processes, including document collection, budget negotiation, and agreement finalization.
Site Monitoring and Management
Remote and Onsite Visits: Perform both remote and onsite monitoring visits for registries according to protocols, Good Clinical Practice (GCP), and SOPs.
Data Management: Review study data, ensure the completeness of eCRF, resolve queries, and maintain contact with the Data Management group.
Safety & Quality: Ensure the safety reporting process is followed, monitor safety data submissions to EC/IRB/RA, and uphold site-level quality control, focusing on audit/inspection readiness.
Site Recruitment & Enrollment: Track patient enrollment and assist with recruitment strategies.
Site Facility & Staff Management: Ensure that site facilities comply with study protocol and regulatory requirements, and assist with site staff training.
Study Administration & Compliance
Study Tracking: Maintain tables, trackers, and databases to monitor study progress.
eTMF Compliance: Contribute to the eTMF process, ensuring proper documentation and compliance.
Study Meetings & Stakeholder Management: Participate in meetings with internal and external stakeholders, ensuring effective communication and collaboration across teams.
About You
Experience
3+ years of experience in clinical research, particularly in clinical trial monitoring. Experience with rare diseases, observational studies, or real-world evidence is a plus.
Attention to Detail and problem-solving skills for monitoring trial data and addressing issues as they arise.
Experience in global projects and working in an international matrix environment.
Skills
Communication: Strong written and oral communication skills for interacting with stakeholders.
Adaptability: Ability to adjust to changing requirements and environments.
Project Management: Skills in managing timelines, budgets, and resources efficiently.
Technical Skills: Knowledge of GCP, regulatory requirements, and clinical trial processes (FDA, EMA, etc.).
Data Management: Expertise in data collection, analysis, and reporting.
Medical Terminology: Proficiency in medical terminology and procedures.
Proficient in Microsoft Office products.
Education
A degree in Pharma, Life Sciences, or related disciplines is required.
Languages
High proficiency in written and spoken English.
Why Join Sanofi?
Inclusive Culture: Sanofi is an equal opportunity employer, promoting diversity, equity, and inclusion.
Career Growth: There are ample opportunities for professional development and international exposure.
Supportive Work Environment: Join a team where you can make an impact while contributing to the global mission of improving lives through science.
Apply now and be part of a company that is innovating healthcare for a better tomorrow.
Discover more about Sanofi’s diversity and inclusion efforts on our website.
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