Clinical Project Manager
What you will be doing:
- Responsible for managing clinical studies under assigned indication, therapy and/or geography
- Leads/direct/Coordinate all aspects of clinical studies from initiation through delivery:
- Site onboarding to include site qualification, contract negotiation/budgeting and IRB/EC approval for the study; ensure all regulatory documentation is collected and current during the study.
- Create all study documentation for study startup, to include the clinical monitoring plan, the CRF guidelines, the data management plan, and support the database build /testing and document all steps in CTMS and RACI
- Perform and document internal stakeholders study training
- Support participating clinical site startup regulatory process
- Track all patient recruitment and treatments within CTMS; work with monitors/CSMs to address all site compliance issues, data issues, and safety issues; elevate issues as needed to Clinical Affairs management.
- Ensure that all sites are current with data entry and conduct routine data reviews to ensure quality of data.
- Ensure all project goals are met per timeline and budget.
- Conduct site initiation/closeout activities per company SOPs.
- Implementation of strategy, scope, process, and programs related to clinical trials
- Provide significant and positive impact to short-term, mid-range, and long-term organizational goals
- Demonstrate continual improvement in product/system development related matters
- Create a work environment that supports cross-functional team effectiveness and promotes efficiencies
What you have:
- Bachelor’s degree in life science field. Advanced degree preferred.
- Professional presentation capabilities directed peer-to-peer, and site investigators
- Good understanding of current working knowledge of clinical trial development from concept through final CSR;
- Minimum of 2 to 3 years of relevant experience in clinical studies management involving IDEs/INDs and/or Class II-III device/drug combination processes.
- Good understanding of data management skills, including descriptive data analysis, consistent with the need for report preparation.
- Knowledge of US clinical trial processes and regulations; familiarity with non-US clinical trial regulations and processes desired.
- Able and willing to travel as needed
- Computer/keyboarding skills and familiarity with Microsoft Office products (e.g., Outlook, Word, Excel, Powerpoint, Sharepoint, TEAMS, and Adobe Acrobat).
Advantages:
- Experience managing clinical vendors (statistical consultants, contract research organizations, core labs, data safety monitoring boards) is a plus
- Being introduced by an Insightec employee
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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