|Clinical Venture Services Ltd provides clinical study support services to the medical device community with a specialist interest in early and late phase start-up med-tech and bio-tech industries. Currently the clinical partner for ReCor Medical Inc. (www.recormedical.com) a start-up medical device company based in Palo Alto, CA, exploring device-based therapies for hypertension, we are recruiting for a clinical data specialist. The role will support the collection, review and reporting of clinical study data including safety, compliance and quality. The ideal candidate would have expertise in medical and clinical data collection and terminology, an understanding of electronic data capture (EDC) systems, case report form development and adverse event and safety reporting processes. They would be independent and proactive; able to think critically and happy to work in small dynamic teams.
- Participate in protocol review, focusing primarily on data management issues and cross-study data collection consistency.
- Participate in the design, documentation, testing and implementation of clinical data collection using electronic data capture (EDC) systems. Includes use of Standard CRFs, design of study specific Unique CRFs, edit check specifications, CRF Completion Guidelines (CCGs) and Data Management Plans (DMPs).
- Responsible for review and resolution of data discrepancies using documented procedures and guidelines.
- Works closely with the Clinical and Medical Affairs teams to aid in data analysis programming and data clean up.
- Produces study database metrics as requested by the Study Management Team
- Provide support to facilitate clinical study payment process
- Support and monitor clinical study device-management, as required.
- Evaluate clinical data to contribute to annual, interim and final reports and clinical information such as final clinical reports and clinical modules of PMA submissions.
- Minimum of a Bachelors’ degree preferably in health-related or scientific discipline
- Minimum of 2 years Clinical Data Management experience or equivalent
- Prior experience in cardiovascular device or pharmaceutical industry preferred
- Knowledge of clinical trial and regulatory process required including GCPs, ICH, FDA and OUS regulatory guidelines.
- Experience with global clinical trials preferred
- Proven experience in data entry; data tracking and clinical trial process preferred
- Experience with on line databases
- Documented experience with Microsoft Office at minimum (Word; Excel; PowerPoint)
- Strong verbal and written communication skills.
- Self-motivated with excellent time management skills
- Fluent in English at a minimum; additional languages an asset (Dutch; French; German)
- Competitive Salary dependent on experience
- Discovery Park gym membership