Responsibilities include but are not limited to the following:
- Review clinical study protocols and service providers’ scope of work documents for sample handling and processing details
- Accountable for preparation of study related documents (biosample management plan, laboratory manual, sample handling sheets etc.) as well as development of shipment schedules, sampling and storage requirements in close collaboration with central and analytical laboratories.
- Training of investigational sites on all topics regarding biosample handling
- Provide specimen updates of received specimens and data to study teams
- Review status of specimens received and completeness of data in data system; create reports for study teams when requested
- Ensure the appropriate level of sample quality, defining corrective actions if necessary, and acting as a point of escalation for issues at the study and project levels.
- Accountable for project level oversight of laboratories/vendors and associated costs involved in biosampling activities and analyses. Provides input to the laboratory selection process to ensure appropriate vendor selection where applicable.
- Delivers expert input on strategic direction and operational considerations for Biomarker sampling to project and study teams.
- Implementation of the biosample strategy within multiple clinical programs in accordance with the requirements of quality, ethical and regulatory standards including ICH/GCP/GLP.
- Leads or contributes to innovation and continuous improvement activities in the area of biosample collection, processing and data delivery.
Qualifications & Experience
- BA/BS in life sciences, medical technology or related field
- 6+ years of directly related experience including clinical development, biospecimen lifecycle management or clinical laboratory analysis. Management experience preferred.
- Extensive experience in leading and managing biosample operational activities on a range of logistically complex multi-center clinical studies, preferred
- Detailed knowledge of the ethical, legal and logistic requirements of obtaining and processing human blood and tissue samples.
- Understanding of ICH, GCP and local regulations
- Very high attention to detail, ability to work independently and excellent multi-tasking skills
- Ability to work with internal and external partners
- Excellent written and spoken English, effective communication and negotiation skills