Contract Manager

Job Description

Job Title: Legal & Contract Manager – Biologics & CRO (Legal Focus) Location: Vapi, Gujarat About the Role We are seeking an experienced Contract Manager with a strong background in legal writing to support global contract management for clinical research organizations (CROs) and pharmaceutical/biologics programs. The role involves drafting, reviewing, and negotiating complex agreements within regulated environments, collaborating cross-functionally with legal, clinical, procurement, and business development teams. Key Responsibilities Draft, review, and negotiate a wide range of agreements including: Clinical Trial Agreements (CTAs) Confidentiality Disclosure Agreements (CDAs) Master Service Agreements (MSAs) Statements of Work (SOWs), Licensing, Consulting & Collaboration Agreement. Ensure compliance with internal policies and external regulations (ICH-GCP, FDA, EMA, etc.) Liaise with internal legal counsel, investigators, sponsors, and CRO partners Track contract timelines, approvals, renewals, and change orders Maintain contract templates and standard terms in line with global guidelines Mitigate legal and financial risks while safeguarding organizational interests Support audits and due diligence processes related to contracts and vendor relationships Preferred Qualifications Bachelor’s/Master’s Degree in Law, Life Sciences, Pharmacy, or related field 5–10 years of experience in contract management within CROs, biologics and biotech industry Strong understanding of clinical development phases and regulatory frameworks Exceptional legal writing, communication, and negotiation skills Proficiency with contract management systems (e.g., Medidata, Veeva Vault, or equivalent) Nice to Have Certification in Contract Law or Clinical Trial Regulations Exposure to biologics, gene therapy, or oncology-related trials Familiarity with global regulatory authorities and submission protocols Show more Show less