Sr. Manager/Manager, Clinical Trials (Medical Device)
- Day to day management of assigned clinical trial to ensure deliverables are met in all phases of trial.
- Ensuring timelines are met.
- Manage trial feasibility process.
- Work closely with study Clinical Operations Lead to execute clinical studies.
- Drafting or reviewing SOPs, ICH/GCP regulations, site materials including training, manuals and support documentation.
- Monitoring of clinical data to ensure timely entry and readiness for data review meetings.
- Review of clinical monitoring reports to ensure timely completion and identification of issues.
- Perform third paty and CRO vendor invoices and data.
- Approve IP releases.
- Maintain trial metrics.
- Oversee and maintain eTMF.
Requirements of the Sr. Manager/Manager, Clinical Trials (Medical Device):
- BS/MS in life science, engineering, or health related discipline.
- Must have industry experience. Preferably at sponsor or CRO level.
- Ideal candidate will have dual pharma and medical device background, medical device strongly preferred.
- At least 5 five years of trial management experience in a clinical research environment early to mid-phase in both patients and healthy volunteers.
- Good project management skills.
- Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
- Must have experience with CTMS.
- Must be comfortable working in a small startup environment.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.