SR Clinical Project Manager

## SR Clinical Project ManagerUS, Remote
· Full-time#### About The Position Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.

Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values – Our Patients, Integrity, Team, Quality and Innovation.

Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work.

Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.

Walking through our corridors, you will be inspired by stories of career journeys  take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.

Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.
** Responsibilities:
*** Responsible for independently leading the clinical trial 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.
* Partners effectively with R&D, Regulatory, Quality, Marketing/Product 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 plans, 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
* Responsible for the activities related to IRBs/ECs, and clinical study vendors (e.g.. core lab, statistical consultants, etc.)
* Develops SAE narratives for DSMB review and manages oversight of the safety profile as per the protocol/stopping rules, local regulations, and IRB.
* Proactively manage the data management and data lock processes of the clinical trial and takes an active role in the final clinical study reporting process
* Responsible for great site relationships with the PI and coordinator to establish trust and collaboration between both parties.
* Ensure annual regulatory reporting is crafted, updated and submitted in a timely fashion.
* Assist/support preparation of registration packages, and activities requiring regulatory agency approvals
* Implement solid strategy, scope, process, and programs related to clinical trials including leading SOP creation, guidelines, and work instructions.
* Effectively communicate scientific information to key stakeholders and support publication activities
* Provide training on disease, indication, protocol, etc to cross-functional teams as well as external collaborators.
* Provide leadership in the development of other clinical project managers within the Global Clinical Affairs team as a mentor
* Provide significant and positive impact to short-term, mid-range, and long-term organizational goals
* Demonstrate process improvement in product/system development related matters such as electronic data capture, image management and clinical trial management systems
* Create a work environment that supports…