Senior Director, Clinical Operations
Contract to Perm
Position Description
Primary Responsibility
- Manage end-to-end enrollment process between research sites and Company
- Responsible for collection and review of screen data in a time-sensitive fashion that does not prolong the screening process
- Liaise with Company Medical personnel to review screen data and ensure per-protocol enrollment of study subjects
- Write and issue protocol exemptions as determined necessary by Company Medical personnel
- Responsible for documentation management with sites, CRO,s and Sponsor Personnel
- Subject matter expert (SME) on patient status tracking
- Able to create functional spreadsheet(s) to track key information on potential patients
- Provide metrics from tracking
- Use tracking to follow-through on all potential subjects until enrolled or no longer interested
- Work with clinical development and clinical operations teams to create SME training as needed for at-site patient identification and enrollment
- Work with CRAs and Clinical Trial Specialists to ensure timely, efficient enrollment and work with CRAs on medical data entry issues at the site level
Additional Responsibilities
- Additional drug development roles will be added as time is available and commensurate with the incumbents interests, such as, but not restricted to:
- Attending and sharing approved information about Company studies at medical congresses
- Coordination with patient advocacy groups
- Review of patient identification processes at research sites and provide remediation on process as appropriate
- Perform medical/clinical review on: data listings, regulatory reports, CSRs, etc.
Candidate Profile
- RN, FNP, PA degree required. Prior nursing or physician assistant experience in Cardiovascular and/or Cardiopulmonary interventions and patient treatment is mandatory
- Minimum 5 years of clinic and/or hospital setting as a health care provider
- Minimum of 2 years functioning in a management capacity
- Minimum of 2 years in a similar role for a Pharmaceutical company or CRO
- Internally motivated to deliver high-quality work products on time and within budget
- Excellent communication and planning skills
- Able to prioritize multi-faceted role against dynamic timelines and rapidly changing corporate needs
- Working knowledge of ICH GCP