Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
- 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 master's 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.