Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Biosample Operations Manager Job

Eingestellt von Yoh

Gesuchte Skills: Support, Client

Projektbeschreibung

BIOSAMPLE OPERATIONS MANAGER needed for a CONTRACT opportunity with Yoh's client located in SOUTH SAN FRANCISCO, CA.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Clinical development
- Biological samples

WHAT YOU'LL BE DOING:

- The Biosample Operations Manager (BOM) plans and coordinates all operational activities required for the collection and delivery of Biosamples (Biomarker, PK and PD) within a clinical study. (Support for gRED studies will also include coordinating assay activities.)
- The BOM is simultaneously assigned to multiple studies and is a member of the SMT for each.
- They provide sample management expertise and may also participate in Biomarker and Pharmacology teams.
- In addition, the BOM is accountable for ensuring that samples collected are of good analyzable quality and are collected in adherence to the highest standards of ethics and informed consent.
- The BOM is the first point of contact for monitors/CRO partners regarding all aspects of biosample handling for Biomarkers, PK, PD.
- 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.
- Accountable for biomarker and PK samples and any other samples deemed by the Biomarker and Experimental Medicine Leader (BEML) and/or Sr. BOM/TA Leader to require special oversight.
- 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 Study Sample Management Plan, a functional deliverable to the SMT, to document cross-functional agreements on the life cycle and reconciliation plan for each sample type.
- Provide input to protocol and ICF to ensure logistical feasibility of biological sampling and alignment with appropriate policies, procedures, and sample testing plans.
- Ensure Sr BOM and/or Biosample TA Lead are aware of all study needs including timelines and protocol requirements so they can be communicated to CSO Heads and/or Central Lab Project Managers.
- Maintain oversight of all study biosample operational activities (for agreed samples) and regularly report on status (including sample collection and reconciling against consent) to the SMT, Sr. BOM/TA Leader and BEML.
- 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
- Maintain professional knowledge of current GCP, biobanking, and sample management policies and best practices and ethical guidelines and apply knowledge appropriately

WHAT YOU NEED TO BRING TO THE TABLE:

- Life sciences degree
- Proven clinical development experience of working in teams running clinical studies, monitoring clinical studies or experience of working in clinical studies at an investigator site
- Proven clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.
- 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
- Proven planning, organizational and time management skills
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team
- Proven effective communication and presentation skills

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Hannah Cihlar

Yoh, a DayJ2W:CLINICAL

MONJOBJ2WSWSCI

Ref:

SFSF: LS

Projektdetails

  • Einsatzort:

    South San Francisco, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Yoh