Clinical Project Manager
Responsibilities:
- Manage successful execution of assigned clinical studies in adherence to Good Clinical Practices (ICHGCPs) and in compliance with the protocol, appropriate company Standard Operating Procedures (SOPs) as applicable under the Regulatory Agency(ies) governing the study
- Accountable for all aspects of clinical operational management and execution of assigned trial(s) to meet company assigned goals, timelines and budget from protocol development, study and site startup, patient recruitment and follow-up, study closeout and report generation for submission to the regulatory agency
- Full responsibility of Clinical Research and Clinical Trials submissions (as/where needed) to governing Regulatory Agency(ies) in full compliance with local regulation and laws.
- Effective management of clinical research activities across multiple projects and effective utilization of internal and external resources
- Builds and sustains great professional relationships across multiple functions at study team level and with external site personnel, vendors, sub-contractors
- Develops and shares best practices to accelerate project timelines
- Be active participant in the global activities ranging from SOP development / review to global 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 English is a MUST
- Professional presentation and training capabilities
- Able and willing to travel as needed, up to 30%
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