Senior Clinical Data Manager

The Clinical Data Manager manages the general conduct of project assigned tasks as the Lead Data Manager or under advisement from senior members of the Data Management Team. Responsible for oversight and conducting data activities in an efficient manner and in accordance with regulations. Responsibilities include all data management activities, customer relationship management where assigned, development and implementation of the data correction process, discrepancy resolution, data control activities, and data validation.

Responsibilities:

· May be designated Lead Data Manager on assigned study, working under oversight of Data Management Team Lead or Senior Data Manager.

· Either as the Lead Data Manager, or assisting designated Lead Data Manager, drives all assigned study data management activities, from study startup through closeout in accordance with SOPs.

· Draft & final protocol review, study specification creation, case report form design, database design/build, form and edit check programming within EDC, and review of all data management specific study documents.

· Implementation of all data cleaning processes, discrepancy resolution, data transfer/control activities, and validation.

· Ensures documentation and management of clinical study data is in accordance with regulations.

· Proactively coordinates and performs start-up, conduct, and closeout activities as detailed within SOPs.

· Participates in reviewing and responding to QA audit reports.

· Proactively participates in appropriate sponsor/project team meetings.

· Leads and/or participates in User Acceptance Testing for projects as needed.

· Assists with development and documentation of department procedures.

· Participates in the review of the cross functional department procedures.

· Trains and mentors junior team members in accordance with the established departmental procedures and SOPs.

· Proactively coordinates and performs start-up, processing and finalization activities as detailed in our SOPs.

Education and Experience:

· BS/BA in health science, life science, information technology, or nursing AND 4 years equivalent experience OR demonstrated aptitude for the Clinical Data Manager role

· Minimum of 4 years pharmacy, clinical lab, or research related experience, study or instruction.

· Experience working in CRO industry preferred.

· Working knowledge of EDC studies.

Skills:

· Excellent organizational skills.

· Strong written and verbal communication skills.

· Technology proficiency including Data Management Systems.

· Study documentation production and maintenance, data processing, data review.

· Knowledge of clinical research including regulatory requirement, GCP/ICH Data Quality.