Description 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 cross-functional team effectiveness and promotes efficiencies
- Contribute to conference abstracts and peer reviewed publications with opportunity to present as applicable.
Qualifications:- Bachelor's degree in a Life Sciences discipline required; Master's degree or other advanced scientific/clinical qualification preferred.
- Exceptional proficiency in professional English, with advanced medical and scientific writing skills, including development of clinical protocols, clinical study reports (CSRs), safety reports, annual regulatory reports, informed consent forms (ICFs), case report forms (CRFs), and other regulatory-compliant clinical trial documentation.
- Demonstrated experience authoring clinical study protocols and contributing to clinical sections of regulatory submissions, including PMA and/or 510(k) applications
- Strong presentation and communication skills, with experience delivering scientific and clinical information to investigators, key opinion leaders, clinical study teams, senior management, and at Clinical User Meetings.
- Comprehensive knowledge of the medical device clinical trial lifecycle, from study concept and design through study execution, data analysis, CSR preparation, and regulatory submission support.
- In-depth understanding of medical device clinical research, including operational, regulatory, and quality requirements, with thorough knowledge of Good Clinical Practice (GCP), FDA regulations, ISO 14155, and applicable global medical device regulations.
- Solid understanding of biostatistics and clinical data interpretation, with the ability to critically evaluate scientific literature and effectively communicate statistical outcomes in clinical and regulatory documents.
- Strong business acumen including presentation, verbal and written communication skills as well as negotiation, partnering, and collaboration without direct line management and including regular communications with senior clinical research physicians and scientists.
- Minimum of 5-6 years of progressive experience in clinical project management, including oversight of IDE, IND, Class III medical device, and/or drug-device combination product studies.
- Experience working directly with regulatory authorities, including FDA, notified bodies, and international regulatory bodies, supporting study submissions, approvals, and ongoing regulatory interactions
- Proven ability to manage and oversee external clinical vendors, including contract research organizations (CROs), biostatistical consultants, core laboratories, data management providers, Clinical Events Committees and Data Safety Monitoring Boards (DSMBs).
- Strong knowledge of U.S., EU, Japan clinical trial regulations and processes; experience with international clinical research regulations and global study execution is highly desirable.
- Recognized subject matter expertise in regional clinical research regulations and compliance requirements.
- Excellent organizational, leadership, and stakeholder-management skills, with the ability to manage multiple complex projects in a fast-paced environment.
- Willingness and ability to travel as required, up to 35% of the time. Expected to travel to support investigator meetings and site initiation visits and support monitoring where needed.
Recruiting Agencies: We do not accept unsolicited resumes from third parties for any of our open positions. To submit resumes for our jobs, a fully executed contract must be in place. We are not working with additional third party agencies at this time.
