Clinical Project Manager
What you will be doing:
- Responsible for leading the study team and managing global clinical trial activities on a pivotal trial or multiple feasibility trials from start-up through study closeout in a manner that manages risk and ensures compliance with the protocol, GCP, and the local governing regulations.
- Effectively communicates and guides / directs the activities of the clinical team members through all the details of large and complex trials, to include regulatory compliance, high quality data collection, and audit readiness that will lend itself to regulatory process approvals.
- In collaboration with stake-holders, supports the regulatory processes with regulatory writing, strategy development, and corrective actions as needed.
- Responsible for management of all clinical studies including activities such as but not limited to:
- Developing project management strategy, cost and timelines
- Identification, qualification, and training of investigators and their teams
- Contribute to protocol writing/amendments, regulatory deficiencies, annual progress reports, final study reports
- Manage the activities related to IRBs/ECs, tumor boards, CROs, and clinical study vendors, CRO, and core labs, and take active role in the management of statistical consultant
- Develops SAE narratives for DSMB review and manages oversight of the safety profile as per the protocol/stopping rules, local regulations, and IRB.
- Proactively assist/ manage the data management and data lock processes of the clinical trial and takes an active role in the final clinical study reporting process
- Develops great site relationships with the PI and coordinator to establish trust and collaboration between both parties.
- Assist/support preparation of registration packages, and activities requiring regulatory agency approvals
- Implement solid strategy, scope, process, and programs related to clinical trials
- Assist / manage in the development of other clinical project managers within the Global Clinical Affairs team as a mentor / leader
- Provide significant and positive impact to short-term, mid-range, and long-term organizational goals
- Demonstrate process 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.
- Advanced writing expertise of all relevant clinical trials documents including protocols, clinical study reports, safety reports, ICFs, designing CRFs,
- Experience writing protocols and clinical trial section of PMA/510(k) desired
- Professional presentation capabilities to site investigators, internal management presentations and/or Clinical User Meetings.
- Demonstrate current working knowledge of clinical trial development from concept through final CSR/PMA; knowledge of operational and regulatory processes involved with device clinical trials; knowledge of GCP and medical device regulations.
- Minimum 5 to 6 years of relevant experience as a Clinical Project Manager with studies involving IDEs/INDs or Class III device/drug combination processes
- Experience with regulatory agencies (FDA and OUS) study(ies) approvals process;
- Experience managing clinical vendors (statistical consultants, contract research organizations, core labs, data safety monitoring boards) desired.
- 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, 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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