Biomarker Operations Project Manager
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.
- 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.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Andrea Rotmistrovsky on +44 203 854 0675 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £500 per day
ProClinical is advertising a vacancy for a Contract Clinical Study Manager
Somerset, New Jersey
ProClinical is partnering with a workforce management solution company to advertise a vacancy for a Remote Project Coordinator
£0.00 - £42000 per annum
ProClinical is advertising a vacancy for a Clinical Project Manager
ProClinical is partnering with a leading multinational organisation
ProClinical is advertising a vacancy for a Senior Research Associate position
Nouvelle opportunitée de CHARGE DE PROJET MEDICAL RWE / RWE SPECIALIST, CDD de 1 an renouvelable, en region parisienne (92)
ProClinical is seeking a Clinical Project Manager to be based in Hamburg on a permanent basis.
ProClinical is excited to announce that an exciting opportunity has arisen for a Clinical Trial Manager
A new job opportunity has arisen for a Regulatory Start-Up Manager position for a scientifically-driven, global, full-service clinical contract research organization.
£0.00 - £70000.00 per annum
A well-known global pharmaceutical company with leading products across various therapeutic areas is looking to hire an Associate Director in Clinical Study Management.