ReCor Medical is looking to recruit a Clinical Data Manager, to be responsible for the data collected from one or more clinical trials. Depending on experience they may also be required to lead the design and development of EDC system requirements, case report forms and other clinical data capture documentation. During the course of the trial, the successful candidate will review and query the data to ensure clinical data collected is clean, accurate and of the highest quality possible. They will be responsible for the database lock of the clinical studies and will assist in final clinical study report writing and review.
Duties & responsibilities include:
- 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 reconcile 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.
- Quality-focused – continuously evaluate, recommend and implement quality improvements as needed.
- Independent and proactive personality; able to think critically and create customer based solutions.
- Minimum of a Bachelors’ degree preferably in health-related or scientific discipline.
- Minimum of 5 years Clinical Data Management experience, either directly or indirectly working with Clinical Data Management.
- Prior experience in cardiovascular device industry preferred.
- Knowledge of clinical trial and regulatory process required including GCPs, ICH, FDA and OUS regulatory guidelines required.
- Experience with global clinical trials desired.
- Experience with MedDRA coding desired.
- Strong verbal and written communication skills.
- Self-motivated with excellent time management skills.
Attractive compensation package, commensurate with experience.
Interested applicants should send a covering letter and a copy of their CV to firstname.lastname@example.org or contact Jane Gregory on +44 1304 806862.