Senior Study Contract Manager - FSP

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