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Clinical Site Agreement Manager

An excellent opportunity to form a new function in a fast-growing biotech company

Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.

Genmab is looking for a Clinical Site Agreement Manager to join the Global Clinical Operations Team at Headquarters in Copenhagen. Global Clinical Operations is part of Clinical Development, which is responsible for managing clinical cancer trials from early First-in-Human (FIH) studies to late stage trials. The function is newly established, and you will have the possibility to influence and further develop the position as Clinical Site Agreement Manager within the company.

Clinical site agreement negotiations are crucial for the successful start-up of clinical trials. As Clinical Site Agreement Manager you will be responsible for reviewing, negotiating and finalizing contracts and budgets for phase I-III clinical trials globally, in close collaboration with the Clinical CRO and internal stakeholders. You will be responsible for the development of the clinical site agreement strategy at trial level in close collabotation with the Clinical Trial Manager and the Legal Trial Representative to ensure timely execution of site agreements.

Moreover, as Clinical Site Agreement Manager you will be the responsible for ensuring that contractual terms and provisions are in compliance with Genmab policies/processes, overseeing the site budgets for the clinical trials, and ensuring compliance with Fair Market Value (FMV). You will act as a Subject Matter Expert in site contract terms, budget building and the resolution/escalation of contract and budget issues.

It is also the responsibility of the Clinical Site Agreement Manager to oversee, maintain and optimize the clinical site agreement processes and provide oversight of contract negotiations between the Clinical CROs and sites; this includes but is not limited to Hospital, Investigator, Pharmacy and Laboratory agreements. Moreover, you will be responsible for ongoing development/review of metrics for contract negotiations and budgets with sites across trials and clinical CROs, together with relevant stakeholders within trial management, legal and finance.

With direct report to Vice President, Head of Clinical Operations.

Your main tasks are:

  • Coordinate and execute clinical site agreements within clinical trial timelimes and in accordance with all applicable regulations, guidelines and SOPs
  • Review wording of clinical site contracts and budgets, and provide input in collaboration with relevant stakeholders
  • Develop and deliver consistent site agreement strategy and oversight, and provide support to Clinical Trial Managers and legal representatives at the trial level
  • Manage issues and risks for individual trials by addressing contract challenges and evaluating site budget. Ensure timely escalations and resolutions of contractual issues in close collaboration with Genmab Legal
  • Develop and monitor KPIs to ensure adherence to trial timelines, including but not limited to timelines for review cycles, contracts, rate limiting for SIV etc.
  • Act as an Subject Matter Expert evaluating country level budget, monitor trends and refine existing guidance, tools, and templates
  • Maintain oversight of the performances of CROs, review the status of site agreements, processes/KPIs, and proactively propose improvements as applicable
  • Attend relevant meetings e.g. Clinial Management Team meetings when strategic decisions impacting site budgets/contract strategy are being discussed in order to provide updates etc.
  • Lead communications with trial teams regarding contracting issues and participate in on-going process improvement
  • Support development of analytical and financial tools to predict costs at trial/project level
  • Ensure that contracts are reviewed for accuracy and completeness, ensuring all corrections are appropriate and documented
  • Facilitate the execution of contracts by signatories and ensure that the dashboard is maintained and up to date 

Your qualifications include a minimum of 3 – 5 years of relevant experience in the biotechnology/pharmaceutical, CRO or healthcare industry. You have experience in Clinical Operations and a thorough understanding of GCP, and relevant ICH standards. Experience with FDA/ EMA guidelines would be beneficial. You have experience in project management and either site contract or budget drafting, negotiation and execution across Phase I-III clinical trials. You are proficient in both written and spoken English. 

You have a Bachelors’s Degree within life science or the equivalent combination of education, training, and relevant experience. 

As a person you have excellent communication (oral and written) and negotiation skills as well as decision-making and presentation skills. You are able to build and maintain relationships. You have strong organizational skills, including the ability to prioritize and handle a high volume of tasks within a given timeframe and are able to work independently as well as in teams. You are capable of prioritizing work in a fast paced and ever-changing environment. You have a quality focus and an eye for detail. You are result and goal-oriented, and committed to contributing to the overall success of Genmab.

Genmab offers a challenging position, where the right candidate will get the opportunity to work with highly specialized people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients. Genmab is an organization with a short chain of command, and you will have the opportunity to influence your own work as well as your personal and professional development.

Domicile: Kalvebod Brygge, Copenhagen

For more details about the job or the company, please contact Partner Jørn Duhn, Unique Human Capital on M +45 21 75 19 25. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
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cvr: 31502705
Stamholmen 157
2650 Hvidovre
Skelagervej 375E
9000 Aalborg
Søren Frichs Vej 42R
8230 Aabyhøj
Unique Human Capital Poland Sp. z o.o.
ul. Gie³dowa 4a, lokal 191
01-211 Warszawa
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