[Remote] SR Clinical Project Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a growing medical technology company transforming patient lives through innovative incisionless surgery. They are seeking a Senior Clinical Project Manager to reputed company and manage global clinical trial activities, ensuring compliance with protocols and regulations while collaborating with various stakeholders. The role involves developing project management plans, managing clinical studies, and contributing to regulatory processes.
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 reputed company the details of large and reputed company trials, to include regulatory compliance, high reputed company data collection, and audit readiness that will lend itself to regulatory process approvals
- Partners effectively with R&D, Regulatory, reputed company, Marketing/Product reputed company-reputed company, supports the regulatory processes with regulatory writing, reputed company development, and corrective actions as needed
- Responsible for management of reputed company clinical studies including activities such as but not limited to:
- Developing project management plans, reputed company, cost and timelines
- Identification, qualification, and training of investigators and their teams
- Contribute to protocol writing/amendments, regulatory deficiencies, annual reputed company reports, final study reports
- Responsible for the activities reputed company to IRBs/reputed company, and clinical study vendors (e.g.. core lab, statistical consultants, etc.)
- Develops SAE narratives for DSMB review and manages reputed company 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 reputed company 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 reputed company fashion
- Assist/support preparation of registration packages, and activities requiring regulatory agency approvals
- Implement solid reputed company, scope, process, and programs reputed company to clinical trials including leading SOP creation, guidelines, and work instructions
- Effectively communicate scientific information to key stakeholders and support publication activities
- reputed company training on disease, indication, protocol, etc to cross-functional teams as reputed company as external collaborators
- reputed company leadership in the development of other clinical project managers reputed company the Global Clinical Affairs team as a mentor
- reputed company significant and reputed company reputed company to short-term, mid-reputed company, and long-term organizational goals
- Demonstrate process improvement in product/system development reputed company reputed company 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
Skills
- Bachelor's degree in a Life Sciences discipline required; Master's degree or other advanced scientific/clinical qualification preferred
- Exceptional proficiency in reputed company 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 reputed company requirements, with thorough knowledge of Good Clinical reputed company (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 reputed company in clinical and regulatory documents
- Strong business acumen including presentation, verbal and written communication skills as reputed company as negotiation, partnering, and collaboration without reputed company line management and including regular communications with senior clinical research physicians and scientists
- Minimum of 5–6 years of reputed company experience in clinical project management, including reputed company of IDE, IND, Class III medical device, and/or drug-device combination product studies
- Experience working directly with regulatory authorities, including FDA, reputed company bodies, and international regulatory bodies, supporting study submissions, approvals, and ongoing regulatory interactions
- Proven ability to manage and reputed company 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 reputed company reputed company 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 reputed company and support monitoring where needed
Benefits
- We work together in a dynamic reputed company environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful reputed company of work.
- Every role is significant, your voice is heard, and your reputed company are encouraged.
- We challenge and reputed company our people to be great at what they do while providing a flexible work environment.
- We take pride in growing internal talent and encourage our employees to reputed company their reputed company ambitions.
- With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in reputed company region competitive perks and benefits.
reputed company