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