Company: CK Clinical
Location: Welwyn Garden City
Closing Date: 15 Mar 17
Salary (£): Negotiable
Lucy Stendall is recruiting for a Biomarker Operations Project Manager in Oncology to join a leading pharmaceutical company at their site based in Welwyn Garden...
Lucy Stendall is recruiting for a Biomarker Operations Project Manager in Oncology to join a leading pharmaceutical company at their site based in Welwyn Garden City on a contract basis for a 12 month contract initially.
The main purpose of the role will be to
- 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 BOPM is assigned to multiple studies and provides biosample operational expertise to the SMT and other stakeholders.
- 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 ICF development to ensure logistical feasibility of biological sampling and alignment with ICH/GCP, appropriate policies, procedures, and sample testing plans.
- Ensure sampling information is appropriately collected for tracking and informed consent reconciliation.
- 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.
- Organise and lead the cross-functional Sample and Data Handling or other stakeholder meetings to drive decisions on sample collection, kit design, shipping schedule, and data deliverables.
- Deliver presentations and trainings at investigator and monitor meetings.
Further responsibilities will include:
- 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.
- Serve as the first point of contact for biosample operational questions and issues for the SMT and scientific business partners.
- Responsible for monitoring effectiveness of investigator site sample handling training and quality of samples received and take corrective action as necessary.
In order to be considered for this role, you will be required to 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 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 and a proven ability in planning, organisational, and time management.
- Proven ability to successfully achieve results within a multi-cultural and geographically diverse team, proven effective communication, influencing and presentation skills as well as a proven ability to build and maintain effective working relationships.
- Experience leading initiatives/ projects.
- Both vendor management and oncology experience would be advantageous.
CK Clinical is an Equal Opportunities employer who 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 CL38267 in all correspondence.
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