Requirements
- Bachelor's, Master's, or Doctorate degree in life sciences plus 12+ years of progressive experience in clinical drug development, including 10+ years of Clinical Operations line management experience.
- Domestic and international clinical trial execution experience.
- Experience and expertise in the conduct and execution of end-to-end global clinical trials, including process and experience within one or more key functions.
- Working knowledge of clinical trial systems (CTMS, IRT, EDC, eTMF).
- Experience working in a matrix environment with other functional groups (e.g. Regulatory, Clinical Supply, Data Management, Quality) where consensus across multiple opinions and good working relationships are important.
- In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Ability to manage early phase clinical programs, through regulatory filing.
- Demonstrated track record of successfully developing and executing on clinical development plans (CDP).
- Proven ability to build strong relationships with external partners, CROs, and vendors including experience managing contracts and clinical finance activities.
- Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
- Willingness and expertise to work effectively in a fast-paced, team-based matrix environment as well as the ability to function independently as appropriate.
- Flexibility to accommodate changes in team and project needs.
- Analytical thinking with excellent problem-solving skills.
- Excellent interpersonal, verbal, and written communication skills.
- Excellent planning, organization, and project management skills.
- Ability to make independent, timely and appropriate decisions.
- Proficiency with project software including Excel and Microsoft Project.
Nice to Have
- Experience with Veeva suite of Vaults (clinical, quality, RIM).
- Experience in training and process improvement.
Compensation
Not specified
Work Arrangement
On-site
Team
Matrix environment
Team
Structure: subfunctions that include, but may not be limited to, Records Management, Monitoring Oversight, BioSample Operations, Inspection Readiness, Systems and Central Services, and Process Improvement/Training.
Other
Travel: Some to considerable national or international travel may be required (~10-25% as needed).
Not specified
