Manager, Biomarker Operations - Mainz, Germany - Permanent
Proclinical is seeking a dedicated and proactive Manager for Biomarker Operations. This is a permanent position located in Mainz, Germany.
Primary Responsibilities:
The successful candidate will be responsible for executing the biomarker strategy, managing operational activities, and ensuring compliance with clinical trial protocols. This role requires efficient communication, meticulous organization, and a strong understanding of analytical methods used in therapeutic areas like Oncology, Immuno-oncology, or Infectious Diseases.
Skills & Requirements:
- Natural/ life sciences or medical background (University degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Laboratory Technical Assistant).
- Experience in clinical operations or central laboratory operations including clinical sample tracking/management (e.g., biomarker, PK/PD) and/or sample reconciliation activities.
- Proven knowledge of analytical methods used in therapeutic areas like Oncology, Immuno-oncology, or Infectious Diseases.
- Experience in (global) project management and ability to work in a matrix team environment.
- Strong organizational and communication skills in English.
- Proficiency in usual software (Word, Excel, Power Point, MS Project).
The Manager for Biomarker Operations will:
- Execution of the biomarker strategy, including planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples in global Phase I-IV clinical trials.
- Ensure biomarker sample related collection, tracking, and storage in compliance with the Clinical Trial Protocol and Patient Informed Consent.
- Management of cross-functional integration and execution of operational biomarker elements.
- Ensuring biomarker operational deliverables in time and quality (including ICH/GCP regulations).
- Building of efficient biomarker sample logistics from study set-up until data delivery and study close-out.
- Establishment and ensuring accurate tracking and reporting of biomarker sample and data metrics.
- Work with internal functions on the selection and contracting process for biomarker sample processing and analysis vendors.
- Act as liaison point for internal labs to ensure efficient communication and information flow.
If you are having difficulty in applying or if you have any questions, please contact Sam Kennaugh at s.kennaugh@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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