Opportunity DetailsOn Assignment
Clinical Data ManagerMalvern, PA
The primary responsibility of the Clinical Data Manager (CDM) is to oversee and manage the Sponsor's clinical programs with regards to data management activities for Sponsor's clinical trials as directed by Sponsor/designee. This includes management, if required, of any 3 rd party vendors and data feeds from those 3 rd party suppliers of the Sponsor.
The CDM will:
- 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.
The CDM will have:
- BS/BA degree with preference in a biological, analytical/data, health related, or computer sciencefield.
- 7-10 years related experience in a pharmaceutical or CRO setting.
- 5 years' experience in Data Management.
- a 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.
- the 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.
