Will be accountable for the planning, coordination and oversight of all operational activities required for the collection and shipment, receipt and reconciliation of clinical trial biosamples from Investigational Sites.
location: Philadelphia, Pennsylvania
job type: Contract
salary: $60 - 70 per hour
work hours: 9 to 5
- Maintain oversight of all study biosample operational activities and regularly report on status, including consent status.
- Provide input into the clinical study protocol and ICF development to review the collection and analysis rationale, to assess the logistical feasibility of biological sampling and to ensure alignment with ICH GCP, appropriate policies, SOPs and sample testing plans.
- Demonstrate operational expertise to ensure deliverables are met, identifying and resolving or escalating issues to the clinical scientist in a timely manner.
- Manage key vendors and CROs to support clinical sample collection, sample storage and sample shipping, including reviewing RFPs, defining scopes of work, and providing ongoing vendor management and contract management in support of the study objectives
- Review the study Biosample Management Plan (BMP) to document cross-functional agreements on the reconciliation plan for each sample type.
- Provide training and support to CRAs and sites for sample collection, handling and shipment.
- Support sample analysis data transfer and data reconciliation.
- Ensure that samples are shipped per the schedule of assessments and that the sample integrity meets requirements necessary for sample analysis.
- Participate in the CRF development process to ensure lab sample information is appropriately collected for sample tracking and reconciliation purposes.
- Review and develop SOPs, work instructions and biosample management processes.
- Assist in the consent reconciliation process for samples and act as a consent expert in the process.
- BSc in Life Science or related discipline
- 3+ years pharma/biotech industry experience in drug development
- 3+ years clinical or biological laboratory experience with hands-on experience in biosample management.
- Strong working knowledge of FDA and ICH GCP regulations
- Effective team player and ability to collaborate with cross-functional stakeholders, both internally and externally.
- Ability to manage lab vendors and oversee biosample management activities across multiple clinical trials and research studies.
- Demonstrated ability to develop SOWs, review contracts, develop budgets and manage key study and biosample management metrics.
- Demonstrated ability to working independently to manage complex projects with multiple priorities in a fast-paced environment
- Excellent written and interpersonal communication skills
- Demonstrated project management skills, with planning, organisation, problem solving and analytical skills.
skills: Clinical Supply Chain
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.