Clinical Study Manager (Contract)
SkyWater has partnered with a client on a contract clinical study manager opportunity. We are looking for an experienced medical device clinical affairs professional to lead a class III study.
The role could be remote for an experienced study leader with occasional visits to their office in the South East metro, or hybrid for someone newer to leading studies.
This is a 6-7 month contract working with a cutting edge, complex device.
Responsibilities
- Lead execution of clinical research activities, including pre- and post-market studies, physician-initiated studies, and clinical documentation supporting global product approval
- Manage operational aspects of clinical trials with project teams in compliance with SOPs, GCP, and country-specific regulations
- Develop and maintain clinical documents (e.g., protocols, informed consent, CRFs, CTAs, investigator brochures/reports) in accordance with global regulatory and ethical requirements
- Collaborate with CROs based on study needs
- Represent clinical research during audits
- Manage clinical trial budgets for assigned projects
- Partner cross-functionally with regulatory, marketing, and product development stakeholders
- Prepare and present project updates and data summaries for senior management
Desired Skills and Experience
- Demonstrated expertise in clinical trial management and execution through education and practical application
- Executes complex work independently with minimal supervision
- Familiarity with IDE trials and submissions is a plus
- Background in start-up, small, or mid-sized company environments is advantageous
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