Merus

Expert Clinical Manager - Utrecht

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Active since 14-06-2017 Job category Health care - Physical
Location Utrecht Level Professional
Educational level Master / Post-Graduate / ... Employment type Fixed term contract with option...
Hours 0 Salary -

Merus is a well-financed biotechnology company based in Utrecht, The Netherlands that is listed on NASDAQ, with several candidate drugs in clinical trials. Merus has developed a leading platform for the generation of bispecific antibody-based (Biclonics®) therapeutics in oncology.

We are currently looking for an Expert Clinical Manager who will conduct all operational aspects of global clinical trial(s) under the management of the Senior Director Clinical Trials and manage other tasks independently. The Expert Clinical Manager will support scientific aspects of clinical trial(s) as assigned and will be responsible for program level activities as assigned.

The role

  • Ensure all operational trial deliverables are met according to timelines, budget, operational procedures, quality/compliance and performance standards under the management of the CTH.
  • Assigned responsibilities can include development of specific sections of protocol and related documents; development of study tools; guidelines and training materials; management of clinical study material; oversight of vendors and other third parties; implementation of issue resolution plan; conduct clinical data review.
  • Prepare clinical outsourcing specifications. Responsible for management of Contract Research Organizations (CROs) and ensure adherence to scope of work within timelines and budget.
  • Support the development, management and tracking of trial budget as assigned, working closely with the appropriate partners internally and externally.
  • Manage interactions with relevant line functions such as Data Management, Drug Supply Management, etc., under the direction of the CTH. Attend Clinical Trial Team (CTT) meetings, participate and report study progress and issues/resolution plan at the Clinical Trial Team meeting.
  • Prepare training materials and presentations related to the planning and conduct of the trial.
  • Contribute to program level activities (e.g., development of clinical sections of regulatory documents such as Investigators’ Brochures, DSUR/PSUR, IND/NDA submission documents) and provide support, as needed, for HA and/or IRB/IEC inquiries.
  • Responsible for education, implementation and compliance to standards (SOPs) and best practices for trial management, including sharing lessons learned.
  • Contribute to talent development through active participation in on-boarding and training activities. Participate in initiatives and working groups.

Our ideal candidate

  • Advanced (e.g., Masters) degree or equivalent education/degree in life science/healthcare
  • 2-5 years of experience in clinical development with a minimum of 2 years in global clinical research. Involvement in cross-functional, multicultural and international clinical trial; demonstrated capabilities in supporting operational aspects of clinical trial related activities.
  • Knowledge of Good Clinical Practice; comprehensive knowledge of clinical trial design; understanding of the overall drug development process.
  • Basic knowledge of oncology, hematology, endocrinology or any appropriate therapeutic area is preferable.
  • Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
  • Proven ability to work either independently or in a team setting, to meet goals by managing compliance, budget and timelines.

We offer
Working at Merus offers opportunity to grow and develop a career that offers both individual and company success.

Merus’ Head Quarters are located in The Netherlands, with offices in the US and collaborators around the world. You will work within an international, talented and stable team in a very inspiring area of Utrecht (Utrecht Science Park) in a brand new state of the art building.
Furthermore, we have an excellent pension scheme, company bonus and we offer 30 holidays based on a full-time position. We care about the team spirit and organize multiple company events a year.

If you are interested in this opportunity please click on the link below to apply or e-mail Femke Markslag, Senior Recruiter, for more information via f.markslag@merus.nl.

More information about Merus is available via www.merus.nl.

More information
This listing is a full-time job

Job category Health care - Physical
Industry / Industries Biotechnology
Region Netherlands
Keywords

Contact information

Name Daniel Logtenberg

Location

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