Manager, Translational Biomarker Operations

Role Summary:

The Manager, Translational Biomarker Operations role is an integral team member will support all aspects of the clinical trial sample life cycle, including inventory management at CROs, shipment initiation and tracking, sample reconciliation and sample testing timelines. The Translational Biomarker Operations Manager will work within the Translational Biomarker team, across all clinical studies and programs, and collaborate cross-functionally with additional teams at Dyne. This person will help in CRO management, the contracting/SOW/PO process, invoice management and meeting management. They will also be responsible for appropriate documentation generation, updating and eTMF filing. The ideal candidate will have the scientific background required to fully understand clinical trial samples and the operational expertise to execute all aspects of sample management and biomarker operations.

This role is based in Waltham, MA without the possibility of being a remote role. 

Primary Responsibilities Include:

• Accountable for the oversight and management of clinical trial samples, including shipment requests, tracking, logistics, sample reconciliation, and life-cycle management to maintain chain-of-custody in a GxP-compliant setting
• Integral team member, accountable for supporting study deliverables and milestones requiring clinical trial sample analysis data and reporting on sample metrics, quality issues, risks, and proposed mitigation strategies
• Helps manage SOW, PO, contract amendments and invoices for Translational Biomarker laboratory vendors
• Helps manage external clinical trial sample processing laboratories and vendors for the Translational Biomarker team and effectively builds standard procedures with services providers to optimize execution
• Attends and/or leads routine meetings with external laboratories
• Oversee development of study specific Translational Biomarker Sample Management Plans in collaboration with key functional stakeholders across teams
• Leads development of innovative sample management process improvement, both internally and externally
• Provide SME support to protocol development, ICF considerations, eCRF build, and feasibility of sample collection
• Works closely with clinical operations, CRO, central laboratories, and/or clinical sites to resolve sample related issues in a timely manner
• Coordinates sample shipments to off-site biobank for long term storage upon completion of study
• Identifies clinical trial sample issues or quality events for Translational Biomarker team and effectively collaborates with the appropriate team members for resolution

 Education and Skills Requirements:

• Bachelor’s degree or equivalent in life sciences or related discipline
• 5+ years of relevant experience with 2+ years of direct experience with clinical trial sample management and biomarker operations
• Experience with clinical sample collection, processing, tracking, reconciliation and storage at either a CRO or sponsor company is required
• Experience with CRO/testing laboratory management, including contracting, PO process and meeting management is highly desired
• Working knowledge with clinical biomarker sample and bioanalytical sample preparation is preferred
• Solid knowledge of clinical development processes with strong emphasis on clinical samples is required
• Familiarity with GxP, ICH/GCP, CAP/CLIA regulations
• Ability to communicate in an open and clear manner (written, verbal and presentation), listen effectively and invite responses and discussions with internal and external partners
• Ability to collaborate effectively with the Translational Biomarker team, cross-functional team members and external partners
• Comfortable in a fast paced, results-driven environment

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