Contract Manager

As a Legal & Contract Manager specializing in Biologics & CRO with a strong focus on legal matters, you will play a crucial role in supporting global contract management for clinical research organizations (CROs) and pharmaceutical/biologics programs. Your responsibilities will include drafting, reviewing, and negotiating various agreements such as Clinical Trial Agreements (CTAs), Confidentiality Disclosure Agreements (CDAs), Master Service Agreements (MSAs), Statements of Work (SOWs), Licensing, Consulting & Collaboration Agreement. You will need to ensure strict compliance with internal policies and external regulations from bodies like ICH-GCP, FDA, EMA, etc. Collaboration with legal, clinical, procurement, and business development teams will be essential in this role. Your tasks will involve liaising with internal legal counsel, investigators, sponsors, and CRO partners, tracking contract timelines, approvals, renewals, and change orders. It will also be your responsibility to maintain contract templates and standard terms in accordance with global guidelines to mitigate legal and financial risks while safeguarding organizational interests. To excel in this role, you are expected to hold a Bachelors/Masters Degree in Law, Life Sciences, Pharmacy, or a related field along with 5-10 years of experience in contract management within CROs, biologics, and biotech industry. A profound understanding of clinical development phases and regulatory frameworks is crucial. Your exceptional legal writing, communication, and negotiation skills will be key to your success in this position. Proficiency in contract management systems such as Medidata, Veeva Vault, or equivalent is preferred. Having a Certification in Contract Law or Clinical Trial Regulations and exposure to biologics, gene therapy, or oncology-related trials would be advantageous. Familiarity with global regulatory authorities and submission protocols is also beneficial in this role. Your role will also involve supporting audits and due diligence processes related to contracts and vendor relationships, ensuring the smooth and compliant operations of the organization.,