ProClinical is seeking a Clinical Data Manager for an international contract research organization providing complete professional services for the clinical research and development of pharmaceutical compounds, medical devices and diagnostic tests in the areas of oncology and life-threatening diseases. This Clinical Data Manager role will be a contract position based in Crawley.
- Act as lead data manager on multiple studies of moderate complexity with minimal supervision
- Main point of client contact for all DM related matters
- Execute all DM start-up activities, including the development and maintenance of
- Edit check and custom listing specifications
- Data Management Plan
- CRF Completion Guidelines
- Conduct user acceptance testing of data outputs per DM specifications
- Organize and actively participate in CRF review meetings with the client
- Perform comprehensive hands-on data review of all patient data through query management and/or manual review in accordance with company SOPs.
- Analyzes study metrics to continually assess both data quality and study progress
- Track and provide project status updates to project managers for monthly project team meetings
- Coordinate with Quality Assurance team to resolve any QA data issues
- May assist in the mentoring of less experienced employees
- Manage and prioritize project deliverables per study timelines
- Reconcile SAEs and work with drug safety
- Ensure that data quality and integrity is maintained from study start through database lock
- Work closely with CRA's to address any negative data trends/issues specifically ahead of site visits
- Provide ad hoc trainings to site members as needed
- May assist the senior data manager based on study demands
Skills and Requirements:
- Bachelor's degree required / Master's degree preferred
- Scope of Responsibility / Level of Independent Decision-Making
- Exercises moderate to high level of independent decision-making
- Performs project specific task and duties with minimal guidance
- Follows established procedures
- 3+ years relevant data management experience in the CRO / pharmaceutical industry required
- EDC experience required
- Demonstrates knowledge of GCPs and protocol
- Strong comprehension and logic skills
- Ability to work independently with minimal supervision
- Proficient in MS Office
- Strong time management and prioritization skills to meet deadlines among multiple projects
- Strong communication skills: verbal/written
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sam Walker on +44 203 8569 336 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.