Sr. Clinical Data Analyst

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Note: These statements reflect the general description of the position and are not intended to be an all-inclusive list of task to which the employee may be assigned.

A. Co-ordinate with CDCs, database programmers and other study team members on study progress.

B. Identify resource for the project and to manage resource needs to meet the study timelines.

C. Creation and revision of standard operating procedure and study related documents.

D. Get involved in study setup activities starting from protocol review, DMP creation, and review of eCRF design as per the protocol requirements.

E. Conduct study setup meeting, delivering data management presentation at Investigator s meeting and to represent data management in various meetings with the sponsor.

F. Provide training to project team as per the requirement and identify the training needs for the self and the team on ongoing basis.

G. Ensure Creation and Maintenance of study binders and other appropriate study related documents until retention period.

H. Provide inputs in defining database specifications, database design, validation programming and testing (UAT).

I. Define the process of External Data handling, SAE Reconciliation and additional data review activities along with Head CDM.

J. Ensure Export and transfer of datasets for statistical analysis as per requirement.

K. Mentor the project team as and when required during the project life-cycle.

L. Coordinate with the study team and communicate the important points to Head CDM.

M. Ensure completion of all CDM activities before database close and lock.

N. Tracking and managing the study, oversee study progress, identify risks and taking corrective action to rectify any errors in consultation with Head CDM.

O. Coordinate with various functional areas such as clinical operations team, statisticians, medical writing team, clinical sites, central lab, other vendors, etc. for seamless project management.

P. Keep the Head CDM informed about the project status in relation to quality and timelines.

Q. Ensure quality on deliverables.

R. Communicate and coordinate with QA team regarding the planned and completed audits, identify the repetitive errors, take necessary corrective action and preventive actions.

S. Monitor metrics (productivity and quality).

T. Participate in recruitment of new staff.

U. Maintain documentation of training as appropriate.

V. Develop, revise, coordinate, schedule and deliver effective training programs for designated staff members.

W. Responsible for mentoring.