Job Title: Clinical Research Manager
Reports To: Director, Regulatory Affairs
FLSA Status: Exempt
Department: Regulatory Affairs

Summary: The Clinical Research Manager will be responsible for developing and implementing clinical strategies, clinical trials, and post market studies effectively while aligning regulatory and business needs. The Clinical Research Manager collaborates with cross-functional teams, external clinical suppliers / vendors, and external key stakeholders such as hospitals, clinicians and government agencies, to ensure effective planning and execution of clinical trials.

Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Oversee the Global Clinical Strategy for the OptiScanner platform system
• Ensure that specific clinical plans and study protocols are consistent with corporate strategy
• Oversight to ensure patient safety, risk management, and compliance to SOPs, Quality System, Good Clinical Practice and applicable regulations for all Clinical Research activities
• Collaborate with cross-functional teams and external resources to assure successful clinical strategy and study execution.
• Communicate the Clinical Strategy to all levels in the company, including Senior Leadership Team, R&D, Regulatory and Marketing groups.
• Serve as clinical department CAPA and Audit champion
• Manage Clinical Research participation in early product definition, planning, and product lifecycle management, including defining new markets and uses for the OptiScanner platform
• Maintain knowledge of competitive or state-of-the-art technologies and applicable regulatory requirements.
• Oversee Clinical Research review of training materials, external communications, and marketing collateral for current and future product lines.
• Responsible for building, developing and leading the Clinical Research function at OptiScan Biomedical
• Coordinate standardized resource assessment and allocation for all clinical activities
• Comply and interface with applicable FDA and international regulatory laws / standards and the OptiScan Biomedical code of conduct.
• Coordinate process improvement initiatives, taskforces, and committees within Clinical Research and cross-functionally.
• Develops clinical protocols, clinical reports, Medical Affairs Strategies, and Clinical Evaluation Reports as needed
• Reviews clinical documents for regulatory submissions (FDA, Competent authorities, Notified bodies, IRBs, CLIA, CMS, etc.) as needed
• May author and implement clinical departmental policies and procedures in order to maintain clinical compliance at sites and internally.
• As the department grows and budget is approved, recruit and retain talent.

Knowledge, Skill and Competency Requirements:
To perform the job successfully, an individual should demonstrate the following knowledge, skills and competencies:

• Experience with metabolic and hemodynamic monitoring in the ICU setting (i.e., glucose, lactate, hemoglobin, oxygenation)
• Experience with CLIA regulations
• Has prior participation in product development and all facets of clinical study development and execution, with both US and international trials preferred.

Bachelor’s degree in a health, medical, clinical sciences or technical field, (e.g. engineering, physiology, nursing, biomedical sciences)

Minimum Five (5) years of experience in clinical research, medical, medical device or CRO setting

Supervisory Responsibilities:
This job has no supervisory responsibilities.

Physical Demands:
The physical demands described within the Specific Job Duties section of this document are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required Training:
The area supervisor or department head (or delegate) shall determine what internal training (if any) is required in order to satisfactorily meet the job requirements listed above. Such training shall be conducted in accordance with applicable SOPs and said training shall be documented in accordance to our internal training procedure. The employee shall also receive general training in both 21CFR 820 and EN13485 as well as the OptiScan Quality Manual and Quality Policy.

This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

If you are interested in applying to an open position at OptiScan, please email your resume to [email protected]