Manager, Clinical Contracts (FSP)

About ExecuPharm/PAREXEL FSP

A global provider of functional service solutions across a range of specialized disciplines for clinical development and biopharmaceutical product lifecycle support including clinical operations, biometrics, safety, regulatory, medical writing, and medical affairs.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.For our European operations we are currently looking for a Clinical Contracts Manager to be fully home-based in one of the European countries.

The Manager, Clinical Contracts is responsible for leading the clinical study contracts team, supporting Seattle Genetics sponsored clinical trials by providing management and oversight of the clinical study contracts process, including the flow of clinical trial agreement lifecycles, negotiating clinical site budgets, conducting business operations as detailed below, and for ensuring that study deliverables are completed on time, with a high degree of quality, and in accordance with corporate and regulatory requirements. This position will work closely with stakeholders such as clinical study teams, clinical project managers, the Legal department, and clinical study site personnel.

Principal Responsibilities Lead the clinical contract, Master Clinical Trial Agreements (MCTA), Non-Disclosure Agreements (NDA), and vendor contract processes Manage the study site budget process from initial template stage to fully negotiated site contracts and amendments. Analyze site contract trends and develop metrics. Benchmark against industry standards. Establish target goals. Work with stakeholders to identify, evaluate, and implement opportunities to improve processes Conduct contract quality control and remediate as needed Ensure consistency in site payment schedules and terms Serve as clinical contract liaison with the Legal group Serve as clinical contract liaison with Contract Research Organizations (CROs), Site Management Organizations (SMOs) and other partners Work collaboratively with the clinical study teams to ensure Clinical Contract deliverables are identified, communicated appropriately and met Manage the contract and/or budget escalation process Maintain the clinical finance database with site and vendor contract budget data Support maintenance of the Legal contract database

People Management Set goals and provide oversight, guidance, mentoring, feedback and performance reviews Manage team workload efficiently across studies to ensure deliverables are met Perform hiring and training activities as needed Provide status updates to management and stakeholders Develop and maintain process documents and tools Adhere to department standards and guidelines Ensure compliance with regulatory requirements Special projects as required QualificationsBachelor’s degree in Life Science, Business or equivalent. MBA preferred

• Minimum four (4) years of global experience working in a biotech or CRO, finance and/or business environment as a contract analyst/specialist

• Experience negotiating contract payment terms and budgets

• Intermediate Excel and database management skills

• Knowledge of GCP/ICH requirements

• Excellent analytical and problem solving skills

• Requires effective organizational and communication skills

• Work both independently and ability to successfully work in a “virtual” team environment

• Has a track record of exceeding goals successfully

• Partners with others to get work done

• Follows through on commitments

• Shows personal commitment and takes action to continuously improve

• Deals constructively with problems that do not have clear solutions or outcomes

• Maintains a positive attitude despite adversity

• Acquires data from multiple and diverse sources when solving problems