Clinical Project Assistant

3+ years

Not Disclosed

Hyderabad

10 Dec. 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Project Lead – ESR and Grants
Location: Hyderabad
% of Travel Expected: Travel required as per business need
Job Type: Permanent, Full-Time

About the Job
Join Sanofi Business Operations (SBO), a key internal resource organization that centralizes processes and activities to support a wide range of Sanofi functions, including Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital. Sanofi Business Operations aims to reduce reliance on external service providers while fostering internal expertise and leveraging a diverse talent pool.

As the Project Lead – ESR and Grants, you will be part of a dynamic team responsible for supporting the Registries team, ensuring adherence to protocols, Good Clinical Practices (GCP) guidelines, and company Standard Operating Procedures (SOPs). This role involves managing electronic Trial Master Files (eTMF) and supporting various project management activities.

Main Responsibilities

Assist the Registries team with the setup and administration of eTMF, ensuring compliance with protocols, GCP, and SOPs.
Oversee the TMF archiving process, including preparation, collection, reconciliation, and filing of relevant documents.
Manage document uploads for all existing and new sites, ensuring primary quality control (QC).
Provide administrative support to the project team, assisting with project schedules and key milestones.
Support project budget tracking and site payments.
Prepare correspondence and meeting minutes for the project team and stakeholders.
Assist in coordinating core file reviews and support audits as required.
Monitor e-Training tracking for project teams and ensure compliance.
Support onboarding of new team members and system access.
Maintain and update Registries SharePoint.
Perform miscellaneous administrative tasks as needed.

People

Collaborate with study teams, including Clinical Project Leaders (CPLs), Clinical Research Associates (CRAs), and site staff, ensuring timely completion of administrative tasks.

Performance

Maintain and update registry study documents.
Conduct routine QC checks of registry study documents.
Ensure correct classification of documents in the eTMF system, ensuring inspection-readiness at all times.
Manage the TMF archiving process for trial documents.

Stakeholder

Understand and meet stakeholder expectations to positively impact the efficiency of the registry study function.
Work cross-functionally and collaborate with peers and partners to enhance registry study execution.

About You

Experience: 3+ years of experience in clinical research and development, including experience with eTMF document management.
Skills:
- Excellent written and verbal communication skills.
- Proficient in eTMF management and attention to detail.
- Strong relationship management skills with study teams and sites.
- Good understanding of ICH-GCP guidelines and clinical trial methodologies.
- Competent in Microsoft Office and emerging technologies.
Education: Bachelor’s degree in life sciences or related field.
Languages: High proficiency in written and spoken English.

Why Choose Us?
At Sanofi, we strive to make a meaningful difference in healthcare, pushing the boundaries of science to create life-saving innovations. We believe in the power of diverse teams and offer an inclusive workplace where every individual can thrive.

Sanofi is an Equal Opportunity Employer, committed to fostering diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, gender, gender identity, sexual orientation, disability, veteran status, or any other characteristic protected by law.

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Clinical Project Assistant

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