The Clinical Data Manager will lead all the data management tasks to ensure that studies are properly designed and presented to successfully support the product development and the resulting regulatory submissions. Essential Duties & Responsibilities: The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned. 1. Represent all aspects of Clinical Data Management (CDM) in a clinical study team environment. Provide advice and solutions to CDM related risks and issues 2. Responsible for the implementation of clinical study database, startup documents, reports, and external data/system planning and incorporation/integration, including but not limited to EDC, IRT, Lab and Central Read data, and integration with CTMS. 3. Manage and ensure CDM quality, timeline and deliverables. Responsible for CDM training, study data collection, data review, query management, medical coding, change management, external data handling, CDM documentation and SAE reconciliation. 4. Responsible for database lock and archival of CDM deliverables and documents. 5. Communicate with other team members, report issues, and coordinate data management related team meetings. Track study data management performance and provide project tracking on an ongoing basis. 6. Perform other data management functions as necessary. Support departmental initiatives.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Demonstrated strong knowledge in medical terminology, clinical study protocol, clinical trial process and therapeutic areas. • Demonstrated working knowledge of EDC Clinical databases, Interactive Response Technology, Clinical Laboratory Data, CDISC understanding, SAS dataset structure, MedDRA and WHO-Drug coding dictionaries • Excellent written and verbal English communication skills. • Proven strong attention to detail • Demonstrated organizational and time management skills, ability to meet deadlines.
Excellent MS Office skills including Excel, Word and Power Point
Bachelor's degree in Science or Medical/Clinical discipline from accredited college or university.
Source: Job Diva – Job Listing