Biosample Operations Manager
Charlene Dutchman at CK Clinical is recruiting for a Biosample Operations Manager to join a leading Pharmaceutical company based in Hertfordshire, on a full time, temporary basis for 6 months.
The Biosample Operations Manager (BOM) will plan, coordinate, and oversee all operational activities required to manage the lifecycle of biosamples (including collection, processing, analysis, data receipt and final repository) of non-safety samples in a clinical study. The BOM is assigned to multiple studies, covering the following therapy areas; Immunology, Infectious Diseases, Ophthalmology and Neuroscience, and will provide biosample operational expertise to the SMT and other stakeholders.
As a Biosample Operations Manager, you have the following responsibilities:
- Accountable for planning, organising and overseeing the collection and shipping of biosamples from investigator sites or centralized locations and subsequent delivery to assay laboratories to meet timelines.
- Provide input during protocol and ICE development to ensure logistical feasibility of biological sampling and alignment with ICH/GCP, appropriate policies, procedures, and sample testing plans.
- Accountable for accurately forecasting and tracking study costs associated with biomarker and companion diagnostic assays, sampling materials, logistics & shipping as needed.
- Give input to assessment of site feasibility for relevant sample processing, collection, storage and shipping to ensure sites can meet sample-handling needs of the study.
- Determine timelines and request the type of internal resource needed for all biosample operational activities, ensuring these are included in study plans and are appropriately tracked.
- Write the Biosample Management Plan (BMP), a functional deliverable to the SMT, to document cross-functional agreements on the lifecycle and reconciliation plan for each sample type and contribute to the development of biomarker-related plans.
- Accountable for ensuring suitable sample handling training and sample collection and processing reference material are provided to the investigator sites, study monitors/CRO partners.
- Deliver presentations and trainings at investigator and monitor meetings.
- Accountable for providing answers to questions from Ethics Committees with regard to repository samples and policies.
- Participate to the biosample day-to-day operational management of CROs (i.e. central lab, etc.) and biomarker assay vendors to ensure delivery against contracted scope of work, including coordination of scope of work development, performance management, and issue resolution.
- Oversee vendors for the duration of the contract to ensure samples are received, assayed, and data is reported according to study timelines.
- Review and approval of invoices (as needed) in financial systems to ensure appropriate work has been completed.
Ensure that investigator sites and/or central labs send samples according to agreed stability shipping schedule for the study and take corrective action where necessary.
Responsible for monitoring effectiveness of investigator site sample handling training and quality of samples received and take corrective action as necessary.
As a Biosample Operations Manager, you will have the following qualifications, skills and experience:
- Life sciences degree or equivalent experience
- Proven clinical development experience working in teams running clinical studies, site monitoring or 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, organisational, and time management skills
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team.
- Proven effective communication, influencing, and presentation skills
- Proven ability to build and maintain effective working relationships
- Experience in leading initiatives/projects.
- Vendor Management experience advantageous
For more information or to apply for this Biosample Operations Manager, position please contact Charlene Dutchman on 01246 45 77 33 or email email@example.com. Alternatively, please click on the link to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL32740 in all correspondence.