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Strategically positioned at the heart of Europe, Stamford Consultants is a specialist recruitment company working within the Swiss and wider IT, Financial and Life Sciences sectors. - Everyday we bring together experienced and talented professionals seeking permanent and contract positions, and ambitious companies looking for key personnel with drive. Our client is a CRO located in the French speaking part of Switzerland. For their team in the Biometry department, they are looking for a - Senior Clinical Data Manager - Permanent - French speaking part of Switzerland - Key responsibilities:
- Create data management plans for assigned projects and manage the execution of plans
- Manage clinical trials and patient registry programs through review, cleaning and auditing of clinical data and databases in compliance with standard operating procedures, client guidelines, contractual obligations and regulatory agency guidelines
- Maintain clinical trial and patient registry data accuracy through review of data for completeness and consistency
- Develop and review electronic data edit checks for web-based forms
- Query data inconsistencies and revise case report forms in compliance with standard operating procedures, client guidelines and regulatory agency guidelines
- Prepare study reports, listings, tables, graphs and other presentations of study data
- Perform coding of adverse events and medications (optional)
- Manage and assist with data base audits as needed
Required skills:
- 4-year degree (BA, BS) required with a science or health-related background degree; equivalent experience in data management and a medical-related field may be substituted for lack of science or health-related degree
- A minimum of 4 years experience in clinical data management is required with at least 2 years of experience in leading and managing data management projects preferred
- Familiarity with medical terminology through formal medical terminology coursework or previous experience is required
- Direct experience with FDA regulations for healthcare such as 21 CFR Part 11A a plus
- An ability to work independently, excellent organizational, communication and interpersonal skills are required
- Knowledge of SAS a plus
- Knowledge of MedDRA and WHO-DRUG coding a plus
- Experience with Electronic Data Capture (EDC) and study startup strongly preferred
Permanent - Ref.Nr.: 4157 If you are interested, please forward me your application by e-mail. KeywordsStamford Consultants AG - Mrs. Emel Buzluk - Friedensgasse 10 - CH-4143 Dornach -
emel@stamford-consultants.com -
www.stamford-consultants.com
