Biosample Operations Manager
The Biosample Operations Manager will be an integral member of the clinical and research teams accountable for planning and coordinating all operational activities required for collection, delivery and disposition of clinical trial and research samples. He/She will provide operational/project management expertise as it relates to sampling, site and patient logistics, and vendor management to ensure deliverables for clinical and pre-clinical programs. He/She will work with cross-functional teams (internal and external) to ensure the clinical trial and research protocols and overall program deliverables are met within timelines, quality and budget. This position will initially report to Sr. Director, Clinical Operations.
Essential Duties & Responsibilities:
- Plan, organize and oversee the collection, shipping, receipt, storage, reconciliation and disposition of biosamples from investigator sites, research facilities or centralized locations and subsequent delivery to assay laboratories or Apexigen. Partner with the clinical and research teams to support a quality biosample dataset in accordance with program timelines.
- Manage relationships with laboratory and other vendors, provide input into trial-specific agreements and assess service level commitments of labs involved in sample analysis. Ensure issues are resolved or escalated in a timely manner.
- In partnership with the Clinical/Translational Lead, provide adequate training and guidance to the investigator sites and study monitors for sample collection, handling and shipment.
- Support sample analysis data transfer and reconciliation.
- Create the Biosample Management Plan (BMP) or laboratory manual, as appropriate, for assigned studies to document the lifecycle and reconciliation plan for each sample type
- Participate in the identification, selection and oversight of central laboratory vendors for sample management, including drafting RFPs and defining scope of work in support of study objectives and goals.
- Accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, sampling materials, logistics & shipping as needed
- Provide regular biosample metrics and status updates. Investigate and address discrepancies detected from the biosample metrics and recommend effective solutions.
- Participate in protocol and Informed Consent Form development to ensure logistical feasibility of biological sampling and alignment with ICH/GCP, appropriate policies, procedures, and sample testing plans
- Provide guidance on country and site feasibility relevant to kit design, sample processing, collection, storage and shipping to ensure sites can meet sample handling needs of the study
- Monitor effectiveness of investigator site sample handling training and quality of samples received and recommend corrective action as necessary
- Participate in the CRF development process to ensure lab sampling information is appropriately collected for sample tracking and reconciliation purposes
- Review and develop SOPs and working practices.
Qualifications & Requirements:
- BS/BA in Life Science or related discipline
- 3+ years industry experience in drug development
- 3+ years clinical or biological laboratory experience with hands-on experience in biosample management
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines
- Proficiency in MS office including Word, Excel, PowerPoint and other applications
- Effective team player and ability to collaborate with cross functional clinical study teams
- Ability to manage lab vendors and oversee biosample management activities across multiple clinical trials and research studies
- Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast paced, team-based environment
- Excellent written and interpersonal communication skills necessary to interface with outside vendors, consultants, and team members.
- Demonstrated strengths in planning, organization, analytical skills, time management, problem solving, good judgement and attention to detail.
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Email resumes to email@example.com. Please reference Job ID: Biosample Operations Manager
Apexigen is an equal opportunity employer