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Site Agreement Manager

Posted: 9/14/2018
Location: Copenhagen, Hovedstaden
Category: Clinical Operations
Req Number: Projects01883

Job Summary

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.

The Role

Genmab is looking for a motivated Site Agreement Manager to join the Global Clinical Operations team at our Headquarters in Copenhagen.

Global Clinical Operations is part of the Clinical Development department which is responsible for managing clinical cancer trials from early First-in-Human (FIH) studies to late stage trials.

Site agreement negotiations are crucial for the successful start-up of clinical trials. As Site Agreement Manager you will be responsible for reviewing budgets and contracts for Phase I-III clinical trials, and provide support in close collaboration with the department from the trial planning and throughout the lifecycle of a clinical trial.

In addition, you are responsible for providing planning, budget and site contract strategy, resolution and escalation of contract and budget issues, and maintaining oversight of the performance of Clinical CROs to ensure compliant and timely execution of site agreements. The Site Agreement Manager is responsible for adherence to all processes, financial transparency regulations and guidelines along with CRO relationship management, acting as a subject matter expert in site contract terms, budget building and the resolution of contract and budget questions.

It is the responsibility of the Site Agreement Manager to oversee, maintain and optimize the site agreement process and provide oversight of the contract negotiations between Genmab, CROs and other sites; this includes but is not limited to hospital, investigator, pharmacy and laboratory. You will work closely with our Clinical Trial Managers and our legal department and you will report to the head of Clinical Operations.

You will be responsible for ongoing development of metrics for contract negotiations and budgets with sites across trials, clinical CROs and provide input for continuous improvement of the overall process.

Key Accountabilities

  • Coordination and execution of site agreements within trial timelines and in accordance with all applicable regulations, guidelines and SOP’s.
  • Liaise with Legal and Clinical Operations team to review wording of 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 (CTMs) at the trial level.
  • Manage issues and risks for individual trials by addressing contract challenges and evaluating site budget escalations.
  • Coordinate escalations to Genmab Legal of general legal issues
  • Develop and monitor KPIs, including cycle times and SIV targets, to ensure adherence to established study timelines.
  • Acting as an SME, evaluate country level budget strategy, monitor trends and refine existing guidance, tools, and templates.
  • Maintain oversight of the performances of CROs, reviewing the status of site agreements, processes /KPIs, and proactively propose corrective actions where applicable.
  • Ensure close collaboration with Clinical Trial Managers, providing information regarding contract statuses, pending issues and prepare correspondence as necessary.
  • Attend Clinical Management Team meetings on an “agenda-driven” basis, e.g. when strategic decisions that impact site budgets/contract strategy are being discussed, 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.

Skills and Experience

  • A minimum of 3-5 years of relevant experience in the biotechnology/pharmaceutical, CRO or healthcare industry.
  • Bachelor’s Degree within life science or equivalent combination of education, training, and relevant experience.
  • Experience in Clinical Operations and a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines would be beneficial.
  • Experience in project management and either site contract or budget drafting, negotiation and execution across Phase I-III clinical trials.
  • Excellent communication (oral and written) and negotiation skills, including conflict resolution, decision making and presentation skills.
  • Strong organizational skills, including the ability to prioritize and handle a high volume of tasks within a given timeframe.
  • Proficient with both written and spoken English.

Moreover, you meet the following personal requirements:

  • You have the ability 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

About Us

Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural culture, all aiming to make a difference for cancer patients.

Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.

If you would like additional information about this position before applying using the link, please contact Uthen Khamproh, Onsite Recruiter (ukh@genmab.com)

Genmab has selected Korn Ferry as a global recruitment partner to help us manage your application.

For more information about Genmab please go to http://www.genmab.com/

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