What are the responsibilities and job description for the Manager Clinical Affairs position at Cypress HCM?
Responsibilities
Clinical Affairs (Primary Focus)
- Support the planning and execution of clinical studies for Bladder CARE, including clinical utility and evidence generation initiatives
- Coordinate study activities with external partners, including investigators, clinical sites, CROs, and vendors
- Assist in development and refinement of study documents, including protocols, case report forms, and study plans
- Track study timelines, milestones, budgets, and deliverables to ensure on-time execution
- Monitor study progress and identify risks or delays, escalating as needed
- Support data collection, data quality review, and coordination with biostatistics or external partners
- Contribute to preparation of abstracts, manuscripts, and scientific presentations
- Support development of evidence packages used for physician education, publications, and payer discussions
- Maintain organized documentation to support study execution and audit readiness
Regulatory Support (Secondary Focus)
- Support CE-IVD / IVDR-related activities by coordinating with external regulatory consultants and internal teams
- Assist in compiling documentation and tracking deliverables required for regulatory submissions
- Maintain regulatory documentation, trackers, and internal files
- Coordinate cross-functional inputs (lab, quality, clinical) required for regulatory activities
- Monitor timelines and ensure alignment with project milestones
Cross-Functional Collaboration
- Provide clinical, scientific and regulatory input to product development teams and senior leadership.
- Work closely with laboratory operations, R&D, commercial, and leadership teams
- Coordinate with external consultants (clinical, regulatory, statistical) as needed
- Support communication of study progress and key updates to internal stakeholders
- Contribute to a collaborative, execution-focused environment in a growing organization
Education And Experience
- Bachelor’s or Master’s degree in life sciences, biomedical sciences, public health, or related field
- 4–7 years of experience in clinical affairs, clinical research, or clinical operations within diagnostics, medical devices, biotechnology, or laboratory testing
- Experience supporting clinical studies, including site/vendor coordination, data tracking, and study execution
- Strong project management skills with ability to manage multiple studies and timelines simultaneously
- Experience working with CROs, investigators, or external clinical partners
- Familiarity with GCP and general clinical research standards
- Strong organizational, communication, and problem-solving skills
Preferred
- Experience in molecular diagnostics, oncology, urology, or laboratory-developed tests (LDTs)
- Experience supporting clinical utility or observational studies
- Exposure to regulatory processes for IVD or CE-IVD / IVDR (direct ownership not required)
- Experience supporting publications, abstracts, or scientific presentations
- Experience in a small or early-stage company environment
Compensation:
$140-160k base bonus