Biosample Operations Manager
South San Francisco, CA
We are currently searching for a skilled professional to join a well-known client’s team as a Biosample Operations Manager in South San Francisco, CA. The Biosample Operations Manager (BOM) is accountable for the execution of the biomarker strategy that includes the planning and coordination all operational activities required for the collection and delivery of clinical trial samples (Biomarker, PK and PD) for assigned studies. The BOM is an integral part of the Study Management Team (SMT) and provides operational/ project management expertise as it relates to sampling, site and patient logistics, and vendor management to ensure deliverables to the SMT or biomarker scientist provided for analysis. The BOM works closely with the Clinical Study Managers, CRO partners, Site Monitors, Data Management, Biomarker Scientist, etc. to ensure the study protocol and overall program deliverables are met.
- Accountable for planning, organizing and overseeing the collection and shipping of biosamples from investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analysable quality
- BOM will also oversee the assay laboratory and ensure delivery of assay results and is the key contact for the assay lab
- Determine timelines and all internal resource needs for all biosample operational activities, ensure these are included in study plans and are appropriately tracked
- Write the Biosample Management Plan, a functional deliverable to the SMT, to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type
- Provide input to clinical study protocol and ICF to review for collection and analysis rationale, feasibility of biological sampling and alignment with policies and study/ program plans
- Utilize operational and project management skills to think through issues to ensure deliverables met
- Raise issues to the Sr. BOM program leader, Biomarker Scientist, or SMT as required
- Maintain oversight of all study biosample operational activities (for agreed samples) and regularly report on status (including sample collection and reconciling against consent
- Sample reconciliation activities as required)
- Accountable for providing answers to ethics questions with regard to repository samples and policies
- Ensures study adherence to ICH/GCP and SOPs
- Identifies areas of best practice and process improvements
- Process development and creation of guidance documents in alignment with USMA and/or PD processes/ SOPs
- Maintain professional knowledge of current GCP, biobanking, and sample management policies and best practices and ethical guidelines and apply knowledge appropriately
- Proven clinical development experience of working in teams running human clinical studies (phase I-IV)
- Monitoring clinical studies or experience of working in clinical studies at an investigator site
- Proven biological laboratory research experience with proficient knowledge of current assay platforms (NGS, RNAseq, etc.)
- Proven critical reasoning skills including the identification and resolution of complex problems
- Detail oriented with the ability to work independently and manage multiple competing priorities
- Proven ability to work successfully under pressure
- Life sciences degree (Bachelor or Master) in Scientific, Medical or Healthcare subject area required. Further qualification, e.g. PhD and/or project management certification is desirable
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.