Clinical Affairs Manager

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