Clinical Study Manager
1 week ago
Modular Medical Inc is seeking a highly skilled Clinical Study Manager to oversee the planning and execution of clinical studies. The ideal candidate will have a strong background in clinical research and experience managing medical device and/or combination products clinical research studies.
Key Responsibilities:
- Develop and implement clinical study protocols, informed consent forms, case report forms, and other essential clinical study documents.
- Oversee and review deliverables produced by study team members to ensure quality and compliance.
- Manage external vendors to ensure timely and within-budget deliverables.
- Ensure studies comply with MMI policies, standards, and procedures, FDA regulations, ISO standards, Good Clinical Practice (GCP), and other applicable regulations.
Requirements:
- 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.
Preferred Skills:
- 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.
Physical Requirements:
Ability to sit or stand for extended periods of time
Ability to lift and/or move up to 35 pounds
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