Clinical Project Manager
Responsibilities:
- Manage successful execution of assigned clinical studies in adherence to International Conference on Harmonization & Good Clinical Practices (ICH-GCPs) and in compliance with the protocol, appropriate company Standard Operating Procedures (SOPs) and applicable regulatory guidelines per geography
- Accountable for all aspects of clinical operational management and execution of assigned trials(s) to meet company assigned goals, timelines and budget including study/site startup, patient recruitment, follow-up and study closeout
- Able to support Clinical Research and Clinical Trials submissions (as/where needed) to governing Regulatory Agency(ies) in full compliance with local regulatory requirements.
- Effective management of clinical research activities across multiple projects and effective utilization of internal and external resources
- Ability to work within a cross-functional Clinical Affairs team
- Develops and shares best practices to accelerate project timelines
- Oversee study submissions to competent authorities, ethics committees, and other review bodies
- Oversee site contracting activities, vendor management and budget negotiation
- Role requires active participation in the Global Clinical Affairs team activities ranging from SOP development/ review to planning of clinical activities
Skills and Experience:
- Bachelor’s degree in science field. Advanced degree preferred
- 3+ years of experience as a Clinical Project Manager with studies involving IDEs and Class II/III device process
- 3+ years of regulatory/clinical trial experience in the medical device industry including experience executing feasibility, pivotal and post-market approved device trials
- Demonstrates current working knowledge of all stages of clinical trial development from concept through final CSR and knowledge of operational and regulatory processes involved with device clinical trials.
- Experience writing clinical trial documents including protocols, ICFs, designing CRFs, clinical study reports, protocol amendments. Writing clinical section of PMA/510(k) is desired.
- Demonstrates data management skills, including descriptive data analysis, consistent with the need for report preparation
- Knowledge of financial principles in budgeting and budget negotiation
- In-depth knowledge of US clinical trial processes and regulations; familiarity with non-US clinical trial regulations and processes desired
- Professional presentation and training capabilities
- Able and willing to travel as needed, up to 30%
Successful candidate(s) will be required to comply with Insightec’s Vaccination Policy.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender/gender identity, age, disability, marital status, sexual orientation, national origin, veteran status, and any other legally protected status entitled to protection under federal, state, or local anti-discrimination laws.
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