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