SR reputed company Project Manager

reputed company

reputed company is a growing medical technology company transforming reputed company lives through innovative incisionless surgery.

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

Our dedication to making a reputed company reputed company on the lives of millions of people and paving the reputed company to a reputed company reputed company for reputed company what bonds us as reputed company. We work together in a dynamic reputed company environment to reputed company successfully while believing and driving a life-work reputed company 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.

Walking through our corridors, you will be inspired by stories of career journeys at reputed company. 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.

Do the most meaningful work of your career by joining us on our mission to reputed company tomorrows, today.

Responsibilities:

• Responsible for independently leading the reputed company trial study team and managing global reputed company trial activities on a pivotal trial or multiple feasibility trials from start-up through study closeout in a manner that manages reputed company and ensures compliance with the protocol, GCP, and the local governing regulations.
• Effectively communicates and guides / directs the activities of the reputed company 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 reputed company 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 reputed company study vendors (e.g.. reputed company 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 reputed company trial and takes an reputed company role in the final reputed company 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, reputed company, process, and programs reputed company to reputed company 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 reputed company collaborators.
• reputed company leadership in the development of other reputed company project managers reputed company the Global reputed company 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/reputed company development reputed company reputed company such as electronic data capture, image management and reputed company 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.

Requirements

Qualifications:

• Bachelor’s degree in a Life Sciences discipline required; Master’s degree or other advanced scientific/reputed company qualification preferred.
• Exceptional proficiency in reputed company English, with advanced medical and scientific writing skills, including development of reputed company protocols, reputed company study reports (CSRs), safety reports, annual regulatory reports, informed consent forms (ICFs), case report forms (CRFs), and other regulatory-compliant reputed company trial documentation.
• Demonstrated experience authoring reputed company study protocols and contributing to reputed company sections of regulatory submissions, including PMA and/or 510(k) applications
• Strong presentation and communication skills, with experience delivering scientific and reputed company information to investigators, key opinion leaders, reputed company study teams, senior management, and at reputed company User Meetings.
• Comprehensive knowledge of the medical device reputed company trial lifecycle, from study concept and design through study execution, data analysis, CSR preparation, and regulatory submission support.
• In-depth understanding of medical device reputed company research, including operational, regulatory, and reputed company requirements, with thorough knowledge of Good reputed company reputed company (GCP), FDA regulations, ISO 14155, and applicable global medical device regulations.
• Solid understanding of biostatistics and reputed company data interpretation, with the ability to critically evaluate scientific literature and effectively communicate statistical reputed company in reputed company 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 reputed company research physicians and scientists.
• Minimum of 5–6 years of reputed company experience in reputed company 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
• reputed company ability to manage and reputed company reputed company reputed company vendors, including contract research organizations (CROs), biostatistical consultants, reputed company laboratories, data management providers, reputed company Events Committees and Data Safety Monitoring Boards (DSMBs).
• Strong knowledge of U.S., EU, Japan reputed company trial regulations and processes; experience with international reputed company research regulations and global study execution is highly desirable.
• Recognized subject matter expertise in regional reputed company 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-reputed company 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.

reputed company Agencies: We do not accept unsolicited resumes from reputed company parties for any of our reputed company. To submit resumes for our jobs, a fully executed contract must be in reputed company. We are not working with additional reputed company party agencies at this time.

Originally posted on Himalayas