Biomarker Operations Project Manager
455 E Grand Ave., SSF44 South San Francisco, CA 94080 | Contract
Bayside Solutions is seeking a Biomarker Operations Project Manager to be part of our client’ s team in the South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
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.
- 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:
- Provides biomarker operational expertise and guidance to global Study Management Teams (SMTs).
- 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 (BOPLs) to execute biomarker operational strategies, serving as a single point of contact for biomarker operations on multiple SMTs, and with internal and external stakeholders.
- Develops and maintains effective working relationships with SMT members, with particular focus on the operational team, diagnostic partners, external CRO & Central Lab (for outsourced teams), and external biomarker vendors, where applicable.
- Builds and maintains effective and efficient high performing biomarker sample* analysis & data delivery.
- Supports relevant stakeholders in their accountabilities, responsibilities and deliverables to drive decisions on timelines.
- Responsible for the identification and selection of biomarker vendors in collaboration with the BOPL, biomarker scientist, GPPS and diagnostics/CDx managers; ensuring appropriate cross-functional input is incorporated into the scope of work.
- Ensure collection, delivery and analysis of biosamples under the highest standards of quality, ethics, and informed consent at study level.
Summary of Qualifications:
- Bachelors or Master’ s degree within Life Sciences, Medical, or Healthcare is required. A PhD or project management certification is desirable.
- 3+ years of related professional experience in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
- Good knowledge of ICH GCP Competencies.
- Must have previous project management skills or experience.
- Global Vendor Management experience is preferred.
- Extensive clinical development experience with evidence of working in teams running clinical studies.
- Pharmaceutical industry experience or experience working as a clinical trial coordinator within a clinical trial setting is a plus.
- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.
- Critical reasoning skills including the identification and resolution of complex problems.
- Ability to plan, organize, and demonstrate strong time management skills.
- Highly flexible working in a fast pace global matrix environment.
- Proven leadership skills, ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Ability to working within a team environment and create team culture and promotes team spirit.
- Professional interpersonal skills, excellent oral/written communication and influencing skills.
- Detail oriented with the ability to work independently and manage multiple competing priorities.