Biomarker Operations Project Manager
ProClinical Recruitment
vor 15 Tg.

A new job opportunity has arisen for an exciting Biomarker Operations Project Manager position at an excellent multinational healthcare company.

ProClinical is advertising this position for a talented and hardworking individual to join the company in its Swiss team, on a contract basis.

Job Responsibilities :

  • Ensuring the timely and efficient delivery of all biomarker operation aspect of one or more studies within the Oncology Therapeutic Area through all phases, supported by Pharma Development.
  • Providing biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams (SMTs).
  • Planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples, including companion diagnostic samples.
  • Closely collaborating with biomarker scientists and Biomarker Operations Program Leaders (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and internal / external stakeholders.
  • Developing and maintain effective working relationships with SMT members, particularly focusing on the operation team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors.
  • Managing the development and oversight of the biomarker analysis timelines, budget, risk, and quality plans.
  • Providing clinical biomarker operations expertise to ensure operational feasibility and delivery.
  • Delivering the operational elements of the biomarker management plan.
  • Providing the day-to-day operational management of biomarker vendors to ensure delivery against contracted scopes of work.
  • Identifying areas of best practice and process improvements; this may including leading or acting as a representative on functional group goals, initiatives, and work-streams.
  • Ensuring study and biomarker operational adherence to ICH / GCP and SOPs.
  • Skills and Requirements :

  • A Bachelor or Masters' degree in a Life Sciences field, preferably Scientific, Medical, or Healthcare.
  • A further qualification, such as a PhD and / or project management certification is desirable.
  • At least three years of demonstrated professional experience in either a clinical research setting, clinical / diagnostic laboratory, or pharmaceutical / biotechnology R&D environment.
  • Proven clinical development experience with working in teams running clinical studies.
  • Proven clinical or biological laboratory experience with evidence of involvement in the processing and / or analysis of biological samples.
  • Demonstrable project management skills and global Vendor Management experience preferred.
  • Critical reasoning skills, focused on identifying and resolving complex problems.
  • Detail oriented with the ability to work independently and manage competing priorities.
  • Planning, organisational, and time management skills.
  • Professional interpersonal skills, excellent oral / written communication, and influencing skills.
  • Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team.
  • Proficiency in English and German preferred.
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