Senior Clinical Data Manager
Senior Clinical Data Manager
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Salary Not Disclosed
1 Vacancy
Job Description
- Participate in clinical meetings with Sponsor and KPS personnel as required.
- Take necessary actions to ensure data management deliverables are met.
- Establish rules and procedures for secure and responsible data sharing with executives.
- Manage data management resourcing for all clinical studies as required.
- Prepare documents and ensure tools are arranged to allow for data capture and data cleaning.
- Ensure delivery of a clean and secure database.
- Instruct communicate coach and mentor others on data management procedures.
- Ensure compliance with EMEA FDA and ICH GCP regulations and policies.
- Ensure compliance with appropriate Sponsor SOPs.
Requirements:
- BS/BA or masters degree with preference in a biological analytical/data health related or computer science field.
- 7-10 years related experience in a pharmaceutical or CRO setting.
- 5 years experience in Data Management.
- Knowledge of EDC solutions (Oracle Clinical Medidata RAVE Inform etc.).
- Experience working on studies both insourced or outsourced to a CRO.
- Current computer literacy in appropriate software (i.e. Current with recent versions of Microsoft Office software suite).
- Strong management and motivation skills.
- Ability to manage study teams and perform issue escalation to meet database cleaning and lock timelines.
- Extensive and comprehensive knowledge of international ICH GCP guidelines.
- Excellent interpersonal written and oral communication skills.
Employment Type
Full-time
