Zurück zur Suche.Stamford Consultants - English - Senior Clinical Data Manager
| Beschäftigungstyp: | Permanent |
| Standort: | Lausanne - Vaud, Switzerland, 1200 |
| Gehalt: | 110'000 CHF |
| Sprachen: | Englisch |
| Erforderlichen Sprachen: | 1 |
Details für die Anzeigenschaltung
- Name:Stamford Consultants
- Veröffentlichung:13-02-2012
- Code:VR/04157
Task
- 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
Profile
- 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
- 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
Profile
- 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
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