Biosample Operations Manager
South San Francisco, CA | Contract
Bayside Solutions is seeking a Biosample Operations Manager to be part of our client’ s team in South San Francisco. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to save patients’ lives.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Biosample Operations Manager
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.
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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 analyzable 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 Roche 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 Roche 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 appropriate.
Summary of Qualifications:
- 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
- Clin Ops/ Med Affairs background IS A MUST (minimally 2 years) and experience in a Clinical Operations function (industry or site).
- 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.
- Biological laboratory research experience with proficient knowledge of current assay platforms (NGS, RNAseq, etc.)
- Critical reasoning skills including the identification and resolution of complex problems.
- Detail oriented with the ability to work independently and manage multiple competing priorities.
- Ability to work successfully under pressure.
- Planning, organizational and time management skills
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
- Effective communication and presentation skills and effective influencing skills
- Ability to build and maintain effective working relationships.