Clinical Data Manager

Responsibilities:

·         Execute end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, data validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, database lock preparation, protocol review, CRF development, database set-up activities and SAE reconciliation in compliance with Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

·         Design, create, validate, review, approve and maintain data management tool specifications

·         Ensure completeness, accuracy and consistency of clinical data and data structure across all projects.

·         Address Regulatory Submission issues within Biometrics and with other related departments.

·         Utilize appropriate CDM concepts and resources to solve moderately complex technical CDM issues.

Qualifications

1. A minimum of B.A. or B.S. degree, preferably in Bioinformatics, Biological Sciences, Medicine, Pharmacy, Nursing, or health care related discipline, master’s degree preferred

Knowledge and Skills:

1. Proficiency on all related regulations, GCP, and Good Clinical DM Practice

2. Knowledge of Medidata Rave, InForm, or Oracle Clinical Data Management preferred
3. Excellent work planning and time management skills
4. Fluent oral and written English skills
5. Able to work under pressure and in a changing environment with flexibility
6. Good communication skills with the ability to communicate with both the technical and business areas.