Opportunity OverviewAs an integral member of the Clinical Operations team, the Manager, Laboratory and Sample Management will be responsible for sample management and laboratory processes within Clinical Operations, CROs and external vendors involved in clinical studies. This position will report to the Senior Director, Laboratory & Sample Management.
Responsibilities and Duties- Day-to-day communication with external diagnostic programs, partner laboratories and CROs to ensure on-time delivery of samples and reporting of data across multiple projects.
- Oversee clinical samples lifecycle management, including central laboratory third party laboratory, and long-term storage inventories to ensure sample holdings meet business and regulatory requirements.
- Sample management and laboratory support of ongoing clinical studies.
- Guiding internal rhythm data exchange, based on samples processed at diagnostic laboratories.
- Support the creation and revision of lab related documents, both internal and site facing.
- Proactive identification, mitigation, and resolution of lab and sample related issues.
- Project management of ongoing clinical laboratory initiatives.
- Support QA activities in auditing and troubleshooting external vendors.
- Participation in quality and operational improvements within the company focused on external laboratory vendors.
- Evaluate capabilities and qualifications of potential and contracted laboratory vendors based on portfolio needs.
- Lab vendor Purchase Order (PO), Statement of Word (SOW), and invoice management.
Qualifications and Skills- BS or BA in a Life Science or related field.
- Minimum of 5 years' experience with CLIA/CAP accredited laboratories or CROs; MLS/MT (ASCP) certification preferred.
- Regulatory knowledge, including Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
- Exceptional organizational skills and ability to deal with competing priorities, strong reasoning, and problem-solving ability.
- Ability to assemble a plan and execute on the details.
- Proficient with MS Office Suite (Excel, Word, and PowerPoint).
- Ability to communicate effectively with internal and external stakeholders.
- Project Management experience preferable
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
The expected salary range for this position is $110,000 - $165,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
