Senior Study Contract Manager - FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Typical Accountabilities · 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 Upon local decision, additional responsibilities may include*: · Training and mentoring of new members of the local Study Team regarding financial/contractual issues and sharing experiences. · Support preparation and negotiation of a Local Master Service Agreement · Contribute to process improvements, knowledge transfer and best practice sharing. *Note: Additional responsibilities may be adjusted locally Education, Qualifications, Skills and Experience Essential · 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. Desirable · Ability to work in an environment of remote collaborators. · Post-graduate training in contracts administration or work experience as a paralegal in pharmaceutical or health care industry · Manages change with a positive approach for self, team and the business. Sees change as an opportunity to improve performance and add value to the business. · Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. · Good analytical and problem-solving skills. · Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. · Familiar with risk-based monitoring approach including remote monitoring. · Good cultural awareness. · Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. · Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. · Good medical knowledge and ability to learn relevant client’s Therapeutic Areas. Key stakeholders and relationships Internal (to client or team) · LSADs and Local Study Teams · Line Manager and local SMM LT · Clinical Quality Associate Director · Local Medical Teams: MSLs and Medical Affairs · Global Study Teams · Global Clinical Solutions functions · Clinical Data Management · Regulatory Affairs · Patient Safety External (to client)

• Investigators and site personnel
• Study related vendors
• Inspectors

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