Specialist/Manager - Biosample Operations (m/f)
|Main focus:||Clinical Operations|
HOOKIPA is seeking a Biosample Operations Manager (BOM) to support our oncology and infectious disease clinical trials. The successful candidate will be an organized self-starter with a collaborative attitude, willingness to learn from mentors, and have the ability to complete project tasks with attention to details. The BOM will be responsible for the operational organization and oversight of biosample, collection and delivery in collaboration with these internal team members, central labs, data management, and analytical vendors.
- Main point of contact for planning and coordination all operational activities required for the collection and delivery of clinical trial samples (Biomarkers, immunogenicity, etc.) for assigned studies
- Engage effectively with central labs, external vendors and internal labs to ensure timely and consistent execution of biomarker processing, analysis and data delivery
- Collaborate closely with biomarker scientists to document the program/protocol biosample plan and provide guidance for operationalization. Implement this plan when working with central labs, confirming collection kit components and design.
- Provides operational/ project management expertise as it relates to sampling, site and patient logistics, and vendor management to ensure deliverables to the study management or biomarker scientist provided for analysis
- Accountable for planning, organizing and overseeing the collection and shipping of biosamples from investigator sites or Central Labs and their subsequent delivery to assay laboratories to ensure timely delivery and optimal analyzable quality
- Maintain oversight of all study biosample operational activities (for agreed samples) and regularly report on status (including sample collection and reconciling against consent; Sample reconciliation activities as required)
- Determine timelines and all internal resource needs for all biosample operational activities, collaborating with the biomarker scientist to ensure all collected samples are available for required analyses per the planned analysis timelines
- Provide input to clinical study protocol and ICF to review for collection and analysis rationale, feasibility of biological sampling and alignment with study/ program plans.
- Contribute to contracting for central lab and biomarker work, ensuring alignment between internal team members and vendors, review SOW, identify and request samples shipments.
- Track, resolve and appropriately escalate issues related to samples and/or data quality.
- Ensure study adherence, regarding biosamples, to ICH/GCP
- Actively partners with CRO Data Management to oversee biosample reconciliation. Coordinate biomarker data format and delivery timelines
- Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
- Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required.
- 3+ years related professional experience in biosample operational logistics in a clinical research setting, clinical/diagnostic laboratory, or pharmaceutical/biotechnology R&D environment.
- Experience of working in teams running an oncology first-in-human clinical studies
- Vendor management experience of overseeing central labs
- Clinical or biological laboratory experience with evidence of involvement in the processing and/or analysis of biological samples.
- Critical reasoning skills including the identification and resolution of complex problems
- Detail oriented with the ability to work independently and manage multiple competing priorities
- Experience in creating and review a biosample tracker
- Ability to work successfully under pressure
- Planning, organizational and time management skills
- Effective communication and presentation skills
- Ability to build and maintain effective working relationships.
What we offer
- Strong team with dedicated and passionate employees
- State of the art infrastructure
- An excellent working atmosphere
- Opportunities for personal development
- Working in a multinational and multicultural environment
Currently remote until safe office-work / commuting can resume. Intention for position to be office-based in midtown Manhattan upon the resolution of the COVID-19 pandemic.
We offer a comprehensive package with competitive salary, paid holidays and sick leave, along with a full range of medical, dental/vision insurance and 401(K) plan. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.
Starting date: as soon as possible