Clinical Research Manager

Triton Medical Robotics, a division of Neptune Medical, is an innovative, venture capital funded medical device startup headquartered in Burlingame, CA.

We have already commercialized novel medical devices using our technology. Now the team at Triton is building something truly unique : a fully flexible medical robot that enables doctors to reach deep into human anatomy.

Our robot will disrupt flexible endoscopy and set a new standard in outcomes for decades to come.

TITLE : Clinical Research Manager

POSITION SUMMARY : The Clinical Research Manager will be responsible for the design, execution and monitoring of clinical studies and will provide scientific expertise throughout the development and implementation of the studies.

S / he will work closely with various study support groups cross-functional teams in order to assist in clinical strategy and will interact with regulatory agencies as needed to support regulatory submissions.

The ideal candidate would act with passion and intensity in a medical device start-up that is fast paced and collaborative and display the ability to perform to the requirements outlined below.

For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a genuinely new type of medical robotic platform.

ROLES AND RESPONSIBILITIES :

• Participate in the development of clinical strategy and trial design.
• Generate study-related documents which may include, but are not limited to, clinical trial protocols, protocol amendments, investigational brochures, informed consent forms, and case report forms.
• Write clinical study reports and scientific publications by evaluating scientific literature, analyzing scientific data and staying abreast of current clinical practice.
• Interpret results in preparation for product applications by evaluating clinical and scientific and risk data and literature and presents scientific data by communicating accurate, succinct summaries of clinical results at investigational meetings and regulatory agency meetings.
• Support analysis of trial performance for opportunities for improvement. Identify and communicate study risks; recommend mitigation strategies and alternative solutions;

and upon leadership alignment lead in the implementation of corrective actions in collaboration with cross functional and / or matrix teams.

• Facilitate regulatory submissions and communications. Interacts with regulatory agencies as needed and use scientific and medical knowledge to write strategic responses to questions from regulatory bodies about submissions.
• Manage study preparation, activation, enrollment, submission, maintenance and closure activities.
• Participate in activities associated with the clinical trial, including training of key personnel and preparation and maintenance of objectives and budgets.
• Ensures appropriate oversight of clinical study by internal and external resources including, but not limited to monitoring staff and CROs.
• Manage and develop clinician, research personnel, peer, cross functional and cross business unit relationships to maximize best practice sharing and optimize processes.
• Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers.
• Supervise training of investigators, site staff and field clinical staff.
• Evaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents.
• Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions.
• Regularly communicates study status to senior management and represents organization to key customers.

REQUIRED QUALIFICATIONS :

• B.S. in Biomedical Engineering or similar
• 5+ years of work experience in clinical research within the medical device industry
• Working knowledge of Good Clinical Practice (GCP), FDA, ISO and other applicable regulations
• Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting
• Excellent written and verbal communication, presentation, relationship management and negotiation skills
• High attention to detail and accuracy
• Fluent in medical terminology and sound knowledge of anatomy
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion / judgment in decision making
• Ability to work and excel within a fast-paced, dynamic, and continuously changing work environment while demonstrating a sense of urgency
• Takes initiative and acts quickly to drive to solutions with a driven outlook and with a strong desire to succeed as a team player, and as a key part of a company
• Ability to travel up 20% domestically and internationally

PREFERRED QUALIFICATIONS :

• Experience in medical robotics
• M.S. in Biomedical Engineering or similar
• Experience or knowledge of the GI / endoscopy space

Triton Robotics is located in Burlingame, CA, near the Millbrae Caltrain and BART Station

Our job titles may span more than one career level. The starting base salary for this role is between $135,000 and $180,000 depending on experience.

The actual base pay is dependent upon many factors, such as : education, training, transferable skills, work experience, business needs, and location.

The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.

Triton Robotics provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.