Job Title: Clinical Project Assistant (CPA)
Company: Sanofi
Location: India
About Sanofi Business Operations
Sanofi Business Operations (SBO) is a global resource organization designed to centralize processes supporting various divisions like Specialty Care, Vaccines, General Medicines, and R&D. SBO aims to reduce reliance on external service providers and build internal expertise across its functional areas.
Main Responsibilities
eTMF Management & Administrative Support
Assist the Registries team in setting up and managing the electronic Trial Master File (eTMF), ensuring compliance with Good Clinical Practices (GCP) and corporate SOPs.
Handle the archiving process for TMF, including document collection, reconciliation, and filing.
Upload and perform Quality Control (QC) checks on documents for all study sites.
Support the project schedule, update key milestones, and collaborate with the Registries team to ensure project timelines are met.
Project Coordination & Budget Tracking
Provide administrative assistance for project management activities, including budget tracking and site payments.
Coordinate and support onboarding of new project team members and ensure system access.
Assist in preparing meeting minutes, correspondence, and project-related documents.
Documentation & Regulatory Compliance
Maintain registry study documents and ensure their timely update in both paper and electronic formats.
Monitor compliance with document upload standards and manage the filing of trial documents to ensure inspection-readiness.
Support audits and coordinate reviews of core files to meet regulatory and quality standards.
Cross-functional Collaboration
Work closely with Clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and site staff to ensure the completion of administrative tasks.
Facilitate effective collaboration between study teams and stakeholders to improve study execution and Registry study efficiency.
Required Qualifications
Experience:
3+ years of experience in Clinical Research & Development, with a focus on eTMF document management.
Knowledge of ICH GCP guidelines and clinical trial methodologies.
Skills:
Soft Skills:
Excellent written and verbal communication skills.
Strong relationship management abilities, with the capacity to manage interactions with study staff at all levels.
Methodical and detail-oriented, with effective task prioritization skills.
Technical Skills:
Proficiency in eTMF management and Microsoft Office products.
Comfort with emerging technologies and mobility applications.
Education:
Bachelor’s degree in life sciences or a related field.
Language Skills:
High proficiency in written and spoken English.
Why Join Sanofi?
Sanofi encourages diversity and is committed to creating a supportive environment for employees. By joining Sanofi, you contribute to groundbreaking healthcare advancements, embracing new ideas, and making a real difference in patient outcomes.
What We Offer:
An inclusive work culture with a focus on diversity, equity, and inclusion.
A platform for professional and personal growth.
Watch the 'ALL IN' video and explore Sanofi’s Diversity, Equity, and Inclusion initiatives here.
Join us in pursuing progress and discovering extraordinary together!
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