Director of Clinical Operations

Location

Fort Collins, CO | United States

Job description

New business development
Multi-year strategies for the firm’s clinical study operations
Professional representation to corporate sponsors
Management of clinical research team and extramural consultants
Regulatory support for veterinary research
- Assessment of product feasibility and study design
- Creation of product development plans
- Participation in regulatory conferences
Planning, management, and leadership of clinical studies
- Preparation of study timelines, budget estimates, and sponsor RFPs
- Prioritization of personnel, time, and supplies across studies
- Sponsor communications on study progress
- Site-, monitor-, and budget-related concerns
- Preparation or review of clinical study protocol, forms, and EDC platforms
- Oversight of:
  - Contract laboratory accounts
  - Study site selection and recruitment
  - Data management activities (form design, data review, query resolution)
  - EDC development/testing
  - Study notebook design
  - Paper data handling
  - Product management
  - Site training and monitoring activities
  - QC/QA activities (audit and monitoring reports, corrective action plans)
  - Project expenses versus budget allocations
  - Study closeout activities
- Veterinary expertise (oversight of AE reporting, concomitant medications, medical reviews)
- Participation in CVM meetings and communications
- Preparation and/or review of final reports
- Maintain SOPs, working guidelines, training programs (study management and personnel)

Benefits

Core requisites

Education: 1) Veterinarian preferred. 2) Other degrees and qualifications considered.
10+ years in clinical research and management
Experience in Good Clinical Practice (VICH GL9 / CVM GFI 85)
Fluency in U.S. regulatory requirements
Proficiency with electronic data capture (EDC) platforms
Knowledge of veterinary medical terminology

S econdary expectations

Job tags

Salary