Senior Study Contract Manager
Parexel - Washington, DC
Apply NowJob Description
The Senior Study Contract Manager (SrSCM) play 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 u00b7 Adapt global templates of agreements to local use in accordance with local requirements and SOPs. u00b7 Develop and negotiate clinical site budgets based on Fair Market Value. u00b7 Negotiate agreement language and budget with clinical study sites. u00b7 Act as point of contact and interface with Legal if necessary to ensure integrity of contracts. u00b7 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. u00b7 Ensure final contract documents are consistent with agreements reached at negotiations. u00b7 Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines. u00b7 Support internal and external audits activities. u00b7 Ensure compliance with clientu2019s Code of Conduct and company policies and procedures relating to people, finance, technology and security. u00b7 Ensure that all contracts are included in the TMF Upon local decision, additional responsibilities may include: u00b7 Training and mentoring of new members of the local Study Team regarding financial/contractual issues and sharing experiences. u00b7 Support preparation and negotiation of a Local Master Service Agreement u00b7 Contribute to process improvements, knowledge transfer and best practice sharing. Note: Additional responsibilities may be adjusted locally Education, Qualifications, Skills and Experience Essential u00b7 Bachelor degree in related discipline, preferably in life science, law, finance or equivalent qualification. u00b7 Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. u00b7 Good knowledge of relevant local regulations. u00b7 Basic understanding of the drug development process. u00b7 Good understanding of Clinical Study Management including monitoring, study drug handling and data management. u00b7 Excellent attention to details. u00b7 Good written and verbal communication skills. u00b7 Good collaboration and interpersonal skills. u00b7 Good negotiation skills. u00b7 Ability to travel nationally/internationally as required. Desirable u00b7 Ability to work in an environment of remote collaborators. u00b7 Post-graduate training in contracts administration or work experience as a paralegal in pharmaceutical or health care industry u00b7 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. u00b7 Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. u00b7 Good analytical and problem-solving skills. u00b7 Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. u00b7 Familiar with risk-based monitoring approach including remote monitoring. u00b7 Good cultural awareness. u00b7 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. u00b7 Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. u00b7 Good medical knowledge and ability to learn relevant clientu2019s Therapeutic Areas. #LI-KW1 #LI-REMOTEEEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Created: 2026-05-11