Biomarker Operations Project Manager

Hobson Prior are currently working with a leading pharmaceutical organisation who focus on preventing, diagnosing and managing diseases. Our client is looking for a Biomarker Operations Project Manager to join them on a contract basis in Hertfordshire, where you will be responsible to ensure of the timely and efficient delivery of all biomarker operational aspects of one or more studies within the Oncology Therapeutic Area through all phases (phase 1b-IV) supported by Pharma Development.

Job Responsibilities:

• Delivers biomarker operational expertise and guidance to one or more cross-functional global Study Management Teams.
• Develops and maintains effective working relationships with SMT members, with focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors.
• Accountable for planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biomarker samples (including companion diagnostic samples) * (collection, processing, analysis, data delivery process and final sample disposition).
• Responsible for collaborating closely with biomarker scientists and Biomarker Operations Program Leaders to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders.
• Manages the development and oversight of the biomarker analysis timelines, budget, risk and quality plans.
• Provides clinical biomarker operations expertise to ensure operational feasibility and delivery.
• Delivers the operational elements of the biomarker management plan.
• Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work.
• Recognises areas of best practice and process improvements; may lead or be a representative on functional groups goals, initiatives and work-streams.
• Ensures study and biomarker operational adherence to ICH/GCP and SOPs.

Key Skills:

• Critical reasoning skills including the identification and resolution of complex problems.
• Detail oriented with the ability to work independently and manage multiple competing priorities.
• Planning, organizational and time management skills.
• Professional interpersonal skills, excellent oral/written communication and influencing skills.

Requirements:

• Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable.
• A minimum of 3+ years related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
• Extensive clinical development experience with evidence of working in teams running clinical studies.
• Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.
• Project management skills and global Vendor Management experience preferred.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.