Senior Study Contract Manager

Job not on LinkedIn

🕒 April 30

🏄 California – Remote

🏄 California – Remote

⏰ Full Time

🟠 Senior

👔 Manager

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Adapt global templates of agreements to local use in accordance with local requirements and SOPs. • Develop and negotiate clinical site budgets based on Fair Market Value. • Negotiate agreement language and budget with clinical study sites. • Act as point of contact and interface with Legal if necessary to ensure integrity of contracts. • For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources. • Ensure final contract documents are consistent with agreements reached at negotiations. • Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines. • Support internal and external audits activities. • Ensure compliance with client’s Code of Conduct and company policies and procedures relating to people, finance, technology and security. • Ensure that all contracts are included in the TMF

🎯 Requirements

• Bachelor degree in related discipline, preferably in life science, law, finance or equivalent qualification. • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. • Good knowledge of relevant local regulations. • Basic understanding of the drug development process. • Good understanding of Clinical Study Management including monitoring, study drug handling and data management. • Excellent attention to details. • Good written and verbal communication skills. • Good collaboration and interpersonal skills. • Good negotiation skills. • Ability to travel nationally/internationally as required.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off