Clinical Data Manager
IL - Deerfield
725 - Biometrics
lunes, 30 de diciembre de 2013
Lundbeck is a global pharmaceutical company conducting research into developing, manufacturing, marketing, selling and distributing pharmaceuticals for the treatment of disorders of the central nervous system (CNS), including depression, schizophrenia, Alzheimer’s disease, Parkinson’s disease, Huntington's disease, epilepsy, insomnia.
The Clinical Data Manager works closely with other programmers, biometric programmers and biostatisticians in supporting the collection and cleaning of clinical data for phase I-IV clinical development programs. The Clinical Data Manager ensures quality, accurate, and timely clinical trial data. This individual reports to the Associate Director, Biometrics.
- Delivers accurate and timely clinical data consistent with organizational standards and in consultation with the study management team.
- Reviews clinical study documents to support efficient data capture including protocols, case report forms (CRF/eCRF), and completion guidelines.
- Authors Data Management/Data Validation plans.
- Maintains working knowledge of internal systems to complete project work.
- Liaises with global counterparts on departmental initiatives such as the development of SOPs, knowledge sharing, and systems life cycle management.
- Understands and conducts work consistent with GCP, ICH, 21 CFR part 11, internal SOPs and training, and international regulatory requirements.
- Other duties as required.
REQUIRED SKILLS AND EXPERIENCE:
- Minimum of 3 years of directly-related clinical data management experience. Experience in clinical data querying, issues resolution, and coordination of Clinical Data Management activities
- Detailed understanding of Electronic Data Capture (EDC) concepts and techniques and of clinical trial principles is required.
- Experience in a pharmaceutical, biotechnology, medical device, CRO, or related environment.
- Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment
- Bachelor’s degree.
PREFERRED EDUCATION, SKILLS AND EXPERIENCE:
- Technical proficiency in clinical data management systems.
- Experience with RAVE electronic data capture system
WILLINGNESS/ABILITY TO TRAVEL
- Up to 10% of domestic travel; international travel may be required.