Clinical Study Manager

At Modular Medical, our goal is to simplify diabetes management, ensuring that everyone has access to the superior care that insulin pumps offer. We believe that managing diabetes should be empowering, not intimidating. You shouldn’t have to be a tech expert or a math genius to take charge of your health. 

Please note: This is an on-site position based in San Diego, CA with up to 50% travel. This role is not eligible for relocation assistance.

The Clinical Study Manager’s responsibilities include, but may not be limited to the following: 

Role and Responsibilities:

• Oversee the planning and execution of clinical studies, including clinical study timeline development, to ensure that deliverables are completed on time and within budget
• Develop clinical study protocols, informed consent forms (ICFs), case report forms (CRFs), and other essential clinical study documents.
• Develop clinical study reports for submission to regulatory authorities.
• Oversee and review deliverables produced by study team members to ensure quality and compliance.
• Manage external vendors to ensure that deliverables are completed on-time, within budget, and are consistent with the scope of work.
• Ensure that studies comply with MMI policies, standards and procedures, FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations.
• Develop and implement standardized processes and operating procedures for conducting clinical research.
• Create and maintain clinical study documents as part of the trial master file (TMF).
• Interact with investigational sites, vendors, key opinion leaders (KOLs) and consultants.
• Conduct on-site clinical monitoring activities as needed.
• Responsible for timely creation and maintenance of clinical study registration updates (ct.gov or global registrations for clinical studies conducted outside of the United States).
• Support the submission of FDA Investigational Device Exemption (IDE) applications, including drafting clinical protocols, investigator brochures, and IDE summary reports.
• Maintain and update the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) in accordance with EU MDR, ensuring integration of clinical data, risk-benefit analysis, and PMS findings.
• Design and execute Post-Market Clinical Follow-up (PMCF) activities, including studies, surveys, and literature reviews, to support ongoing safety and performance of Modular Medical products.
• All other duties as assigned 

Education and Experience:

• BA/BS degree in Health or Life Sciences required, advanced degree preferred.
• Five (5) or more years of experience in Clinical Research.
• Three (3) or more years of experience managing medical device and/or combination products clinical research studies.
• Experience in the diabetes industry preferred.
• Strong working knowledge of Good Clinical Practice (GCP), FDA and ISO regulations, and current industry practices related to the conduct of clinical studies

Skills Preferred:

• Strong analytical and problem-solving skills, including the ability to conduct risk assessments and develop risk management plans.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and regulatory agencies.
• The ability to effectively prioritize tasks and responsibilities and ensure project milestones are met or exceeded.
• Ability to handle multiple tasks while ensuring timely and accurate completion
• Clinical Research certifications from ACRP or SOCRA preferred.

Physical Requirements:

•       Ability to sit or stand for extended periods of time 

•       Ability to lift and/or move up to 35 pounds