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.
Parexel FSP is hiring a Senior Study Contract Manager to join us on a
permanent full-time, home-based basis.
The position can be based in the Netherlands or Belgium
If you’re driven by the potential of science to create meaningful change and
eager to explore your capabilities, join us.
Dedicated to a single sponsor in BioPharma, who is revolutionizing healthcare by harnessing the power of science to benefit people, society, and the planet. Turkey is a vital part of their global network, hosting colleagues from every segment of the life sciences value chain. Their science-driven approach aims to transform healthcare and improve patient outcomes, while also fulfilling a
purpose-led role in society.
The Senior Study Contract Manager (Sr.SCM) 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. Sr.SCM has regular communication with investigators and institutions as well as other key external and internal stakeholders.
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Adapts global templates of agreements to local use by local requirements and SOPs.
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Develops and negotiates clinical site budgets based on Fair Market Value.
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Negotiates agreement language and budget with clinical study sites.
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Acts as point of contact and interface with Legal if necessary to ensure the integrity of contracts.
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For each agreement, maintain the status of the agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources.
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Ensures final contract documents are consistent with agreements reached at negotiations.
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Ensures all agreements are executed promptly contributing to efficient site start-up timelines.
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Supports internal and external audit activities.
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Ensures compliance with client’s Code of Conduct and company policies and procedures relating to people, finance, technology, and security.
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Ensures that all contracts are included in the Trial Master File (TMF).
ESSENTIAL REQUIREMENTS
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At least 2 years of experience in site contract negotiation/customization.
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Experience in negotiating contracts with clinical investigative sites/hospitals.
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Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
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Good knowledge of relevant local regulations.
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Basic understanding of the drug development process.
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Good understanding of Clinical Study Management including monitoring, study drug handling, and data management.
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Experience of Netherlands contracts.
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Desirable - experience with Belgium contracts.
Education:
Bachelor’s degree in a related discipline, preferably in life science, law, finance, or equivalent qualification.
Apply today!
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What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com.
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