Our Team:
Sanofi Business Operations (SBO) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.
The Sanofi Business Operations is built to reduce reliance on external service providers and facilitate the development of internal expertise. The Sanofi Business Operations will leverage an untapped combination of talent pool.
Main responsibilities:
The Clinical Project Assistant (CPA) will support for the below:
Provide support for the set up and administration of electronic Trial Master File (eTMF) and IMPACT CTMS/eSTRA and relevant clinical operations tools ensuring adherence to protocol, Good Clinical Practices (GCP) guidelines and company Corporate and Local Standard Operating Procedures (SOPs).
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2. Provide support for setup from the beginning to its closure which includes collection, archiving, uploading for the existing as well as new sites and ensure quality control.
3. Project administration and coordination as project execution, reporting, track progress against the timelines and milestones.
4. Draft, update, maintain key study related documentation including share points, tools, manuals, SOPs, useful links, training guides.
5. Maintain study portals with relevant content accessibility and change/amend the versions as per the process.
6. Provide support in budgetary tracking and site payments as and when required.
7. Prepare meeting minutes, status reports, stakeholder updates, conduct meetings if necessary.
8. Perform file review, support internal and external audits by ensuring document readiness and completeness.
9. Assist onboarding of new team members, providing tools access support and orientation support.
10. Maintaining e- training records, monitor completion rates, inform and ensure team compliance with mandatory learning requirements.
11. General administrative support which included miscellaneous activities when required and connect with local countries for local language document review (English/Japanese).
12. Serves as a point of contact between operations team and stakeholders and update site milestone & IRB/IEC approval dates, enrolment metrics for the site/ country as applicable
13. Collaboration and stake holder engagement which includes engaging with CPLs, site staff, cross- functional teams.
· People: (1) The CPA is part of the study team and will collaborate with the people involved in the conduct of the Study from the start-up, up to the closing and archiving activities.
(2) CPA will interact with the clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and site’s staff, when applicable, to ensure that all the administrative tasks are completed in a timely manner.
· Performance: (1) Maintain study documents (2) conduct routine QC check of study documents
· Process:
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· Stakeholder: (1) Commit to Customers – Understand, meet, and excel internal and external stakeholders’ expectations to create positive impact through the evolution of the study function. (2) Cooperate Transversally – Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact study efficiency and execution.
About you
Experience:
3+ years of experience in Clinical research & development including clinical trial eTMF document management experiences.
Understanding of ICH GCP guidelines and clinical trial methodologies required.
· Soft skills:
• Excellent written and oral communication skills needed.
• Excellent eTMF management skills.
• Ability to maintain confidentiality of data and information during interactions with study staff at all levels and across studies and sponsors.
• Effective relationship management, sites, and study teams.
· Technical skills:
• Methodical approach to work and prioritization of tasks
• Understanding of the principles of ICH-GCP and applicable local regulatory requirements
• Be comfortable with emerging technologies, mobility applications.
• Excellent cross-functional collaboration skill and experience required.
• Competent with Microsoft Office products.
Education: A bachelor’s degree in life sciences or a related field.
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· Languages: High Proficiency in written and spoken English.
Pursue progress, discover extraordinary.
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!