Clinical Project Assistant
SanofiÂ
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Job Description
 Location: Hyderabad, Telangana, India (Hybrid)
Job ID: R1594980
Job Overview
As a Global Trial Acceleration Associate, you will play a vital role in supporting the successful execution of global clinical trials. This individual contributor position focuses on centralized activities such as clinical documentation management, regulatory submissions, and site activation processes across all phases of clinical research.
You will collaborate with internal teams, clinical sites, vendors, and contract research organizations (CROs) to ensure high-quality, compliant, and efficient trial operations driving BMS’s mission of transforming patients’ lives through science.
Role & Responsibilities
- Manage and execute centralized operational activities supporting global clinical trials, with a focus on documentation and compliance.
- Serve as a primary point of contact for essential document management and submission-related activities throughout all phases of the study (start-up, maintenance, and close-out).
- Collaborate with Country Trial Managers (CTMs), Clinical Trial Monitors (CTMos), and vendors to support timely completion of study deliverables.
- Initiate and manage start-up documentation and ethical/regulatory submissions to ensure adherence to global and regional standards.
- Review, track, and maintain Site Monitoring Visit reports; identify and escalate issues as needed to ensure resolution and follow-up.
- Oversee country and site activation processes including document review, validation, and checklist completion prior to site initiation.
- Support outsourcing and vendor coordination, ensuring compliance with BMS’s quality, procurement, and regulatory standards.
- Maintain and update clinical systems such as CTMS, eTMF, and related vendor platforms for accurate trial status reporting.
- Facilitate certified translations of key documents (e.g., Informed Consent Forms, Protocols, Investigator Brochures) as required.
- Coordinate or create study-specific materials, including investigator and pharmacy site files, for site initiation visits.
- Provide quality control checks and maintain standardized templates for consistent documentation.
- Contribute to Clinical Study Report (CSR) distribution and Informed Consent Form (ICF) adaptation at country and site levels.
- Support continuous communication with global study teams to ensure operational efficiency and regulatory compliance.
- Perform other duties as assigned to support successful trial delivery.
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Educational Qualification
- Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Experience: 0–2 years of relevant experience in clinical research, trial coordination, or document management preferred.
- Strong understanding of ICH-GCP guidelines, clinical operations, and trial documentation.
- Excellent communication and collaboration skills for cross-functional teamwork.
- Proven attention to detail, organization, and problem-solving abilities.
- Proficiency in MS Office and familiarity with clinical trial management systems (CTMS, eTMF).
- Ability to multi-task and manage priorities in a dynamic, fast-paced environment.
- Commitment to quality, ethics, and continuous learning.
Location
Hyderabad, Telangana, India (Hybrid)
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