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