At DEKA, we're changing what's possible through bold ideas, cutting-edge engineering, and groundbreaking medical technologies. As a Clinical Research Manager you will study ground breaking medical devices in actual clinical use-from planning and site onboarding to data analysis and regulatory submission. This is a hands-on, high-impact role where your contribution will directly influence trial success and, ultimately, the patients who benefit from our innovations.
How you will make an impact as a Clinical Research Manager:
- Clinical Trial Operations:
- Develop, review, and maintain trial documentation, including protocols and statistical analysis plans.
- Oversee investigational device supply, product support, and failure analysis.
- Manage safety endpoints, risk mitigation, and timely site contracting/certification.
- Partner with CROs to ensure multi-site trials are onboarded, monitored, and supported.
- Drive Data Integrity & Compliance:
- Track recruitment, milestones, trial requirements, and key endpoints.
- Compile documentation for regulatory reporting during and after the trial.
- Oversee data collection for completeness, accuracy, and integrity in collaboration with monitoring teams.
- Maintain the Trial Master File and resolve missing or incorrect data in partnership with CROs.
- Collaborate Across Teams:
- Work closely with product development to understand device design and performance.
- Investigate and track device-related issues from the trial.
- Coordinate product shipments with contract manufacturers, ensuring accountability and compliance.
- Communicate consistently with investigators, site staff, and internal stakeholders.
What you need to be successful in this role:
- Minimum of a Bachelor's degree in a technical field
- 3+ years experience with medical devices
- Proven ability to lead complex projects and build strong cross-functional relationships.
- Exceptional problem-solving and critical thinking skills.
- Excellent organizational skills with the ability to manage multiple priorities at once.
- Strong communication skills, written and verbal.
- Proficiency with Microsoft Excel preferred.
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research &Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA's brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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