Senior Study Contract Manager - FSP

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<p><b>When our values align, there's no limit to what we can achieve.</b><br> <br>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.</p><p>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.</p><p></p><p></p><p><span><b>Typical Accountabilities</b> </span></p><p><span>· Adapt global templates of agreements to local use in accordance with local requirements and SOPs. </span></p><p><span>· Develop and negotiate clinical site budgets based on Fair Market Value. </span></p><p><span>· Negotiate agreement language and budget with clinical study sites. </span></p><p><span>· Act as point of contact and interface with Legal if necessary to ensure integrity of contracts. </span></p><p><span>· 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. </span></p><p><span>· Ensure final contract documents are consistent with agreements reached at negotiations. </span></p><p><span>· Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines. </span></p><p><span>· Support internal and external audits activities. </span></p><p><span>· Ensure compliance with </span><span>client</span>’s Code of Conduct and company policies and procedures relating to people, finance, technology and security. </p><p><span>· Ensure that all contracts are included in the TMF </span></p><p><span> </span></p><p><span><b>Upon local decision, additional responsibilities may include*:</b> </span></p><p><span>· Training and mentoring of new members of the local Study Team regarding <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">financial/contractual</span> issues and sharing experiences. </span></p><p><span>· Support preparation and negotiation of a Local Master Service Agreement </span></p><p><span>· Contribute to process improvements, knowledge transfer and best practice sharing. *Note: Additional responsibilities may be adjusted locally </span></p><p><span> </span></p><p><span><b>Education, Qualifications, Skills and Experience</b> </span></p><p><span><b><u>Essential</u></b> </span></p><p><span>· Bachelor degree in related discipline, preferably in life science, law, finance or equivalent qualification. </span></p><p><span>· Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. · Good knowledge of relevant local regulations. </span></p><p><span>· Basic understanding of the drug development process. </span></p><p><span>· Good understanding of Clinical Study Management including monitoring, study drug handling and data management. </span></p><p><span>· Excellent attention to details. </span></p><p><span>· Good written and verbal communication skills. </span></p><p><span>· Good collaboration and interpersonal skills. </span></p><p><span>· Good negotiation skills. </span></p><p><span>· Ability to travel <span style="overflow-wrap: break-word; display: inline; text-decoration: inherit; hyphens: auto;">nationally/internationally</span> as required. </span></p><p><span><b><u>Desirable</u></b> </span></p><p><span>· Ability to work in an environment of remote collaborators. </span></p><p><span>· Post-graduate training in contracts administration or work experience as a paralegal in pharmaceutical or health care industry </span></p><p><span>· 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. </span></p><p><span>· Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. </span></p><p><span>· Good analytical and problem-solving skills. </span></p><p><span>· Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. </span></p><p><span>· Familiar with risk-based monitoring approach including remote monitoring. </span></p><p><span>· Good cultural awareness. </span></p><p><span>· 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. </span></p><p><span>· Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. </span></p><p><span>· Good medical knowledge and ability to learn relevant </span><span>client’s</span> Therapeutic Areas. </p><p><span> </span></p><p><span><b>Key stakeholders and relationships</b> </span></p><p><span><b><u>Internal (to </u></b></span><span><b><u>client</u></b></span><b><u> or team)</u></b> </p><p><span>· LSADs and Local Study Teams </span></p><p><span>· Line Manager and local SMM LT </span></p><p><span>· Clinical Quality Associate Director </span></p><p><span>· Local Medical Teams: MSLs and Medical Affairs </span></p><p><span>· Global Study Teams </span></p><p><span>· Global Clinical Solutions functions </span></p><p><span>· Clinical Data Management </span></p><p><span>· Regulatory Affairs </span></p><p><span>· Patient Safety </span></p><p><span> </span></p><p><span><b><u>External (to </u></b></span><span><b><u>client</u></b></span><b><u>)</u></b> </p><p><span>• Investigators and site personnel </span></p><p><span>• Study related vendors </span></p><p><span>• Inspectors </span></p>

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