Lead Sr. Clinical Data Manager

Yoh Clinical's client has an immediate need for a Lead Senior Clinical Data Manager. The Senior Clinical Data Manager will report to the Manager of Clinical Data Management.

ESSENTIAL FUNCTIONS:
The individual will plan, coordinate, and track data management tasks for clinical studies performed internally or outsourced to CROs. Participate in validation of Clinical Data Management System. The Individual must have previous experience with a EDC system, from start-up of the trial through completion. Review study protocols; develop and annotate CRFs and CRF Completion Guidelines; develop, implement and maintain Data Management plans; provide written and/or verbal status reports to department and project team; perform medical coding; and supervise contracted resources. Must have a thorough understanding of CRF design and implementation. Participate and run team multidisciplinary team meetings.

Requirements:

Education:

?  Must have at least a Bachelor degree in scientific discipline.

Specific Skills:

?  At least 5 years experience in clinical data management.

?  Demonstrated proficiency initiating and managing clinical data projects.

?  Knowledge of and experience with relational databases, medical terminology as well as demonstrated written and oral presentation abilities is also required.

?  Familiarity with GCP, ICH and FDA regulatory requirements as they apply to clinical data management.

?  Knowledge of medical terminology and clinical trials data structure.

?  Experience with Microsoft window and office is necessary.

?  Ability to follow technical directions and specifications.

?  Strong attention to details and solid follow through.

?  Ability to complete deliverables on time and adjust priorities in a fast paced environment.

?  Independent self-starter with high initiative.

?  Passion for effecting positive change.

?  Proven successful experience in running team meetings.

?  Focused and persistent on quality.
 

 For immediate consideration, please forward your resume to