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(Senior) Clinical Data Manager

Utrecht, Netherlands
Merus is seeking a skilled Clinical Data Manager to join our dynamic Biometrics team. With a focus on oncology, this role is pivotal in leading and coordinating the end-to-end quality deliverables of data management activities for one or more clinical trials. This includes study setup, conduct, and closeout, ensuring compliance with GCP and applicable regulatory guidance. Reporting directly to the Vice President of Biometrics, you will play a critical role in maintaining our high standards and driving our clinical research forward.

Your Role

As a Clinical Data Manager, you will:

  • Act as the sponsor lead data manager for one or more clinical trials.
  • Oversee vendors and ensure implementation of Merus standards across trials, ensuring the integration of project protocols into daily operations.
  • Serve as the primary liaison between CRO Data Management groups and Clinical Trial Teams, facilitating effective communication and collaboration.
  • Collaborate on CRF design, statistical planning, and Clinical Study Reports to optimize data management strategies.
  • Ensure the development and maintenance of data management project documentation, perform independent reviews of data management deliverables, and manage the operational and financial aspects of data management tasks.
  • Identify and manage data management milestones and project risks, ensuring that data management objectives are met with quality and on time.
  • Act as the clinical data custodian, liaising between vendors, ensuring compliance with regulatory guidelines and documentation requirements, and monitoring the data cleanup process conducted by CROs from study start-up through data archiving.
  • Manage existing company standards related to the collection, handling, and review of clinical trial data, and process requests for new standards as needed.

Your Profile:

If you are driven to achieve, excel in collaborative environments, and are dedicated to advancing cancer treatment, we encourage you to apply.

Requirements:
  • A University Degree in Biomedical Sciences or a related field; an Advanced Degree is preferred.
  • 6-8 years of data management (especially in Oncology), preferably on the sponsor as well as the CRO side.
  • Industry-level experience with CDISC, CDASH, SDTM, and related industry and health authority initiatives.
  • Strong leadership skills and the ability to work collaboratively across teams.
  • Proven ability to manage risks and deliver high-quality clinical data on time and within budget.
This position offers the opportunity to be at the forefront of data management within a company that is passionate about developing advanced therapies for cancer treatment. You will have the chance to work with cutting-edge biometrics applications and software tools, providing expert input and taking a leadership role in shaping the future of clinical data management at Merus..

Our Offer:

We offer a once-in-a-lifetime opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll experience a steep learning curve from your very first day in the job. And you’ll get to interact with a great international team of people who love what they do! To top it all, we offer a competitive salary, flexible working hours, an excellent pension scheme, a company bonus and 30 days’ annual leave (based on a full-time position). Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.

Blijf op de hoogte van de laatste farma vacatures

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Blijf op de hoogte van de laatste farma vacatures