INTRODUCTION

The Senior Study Contract Manager (SrSCM) plays an important role in driving the costings and contracts, being responsible for negotiation and budgeting in clinical trials and for developing and managing contracts and annexes with investigators and institutions or external vendors, ensuring ethical, fair, and compliant practices.

SrSCM has regular communication with investigators and institutions as well as other key external and internal stakeholders.

SCM might have different internal titles based on the experience level (SCM, Senior SCM). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks, or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head or Executive Director, Regional Head.

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.

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 the 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.

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