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
Apply To This Job
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
Apply To This Job