Sr. Data Manager

DescriptionThis position will report to the Senior Manager, Data Management.

Skills & Abilities:

Strong Oral and written communication skills
Strong Organizational and time management skills
Ability to establish and maintain a good working relationship with all functional areas
Ability to multi-task and work independently
Strong sense of urgency and leadership abilities
Attention to detail
Able to make quick decisions, solve problems, and adapt to changing environments and requirements
Team building and Project Management experience required
Primary Responsibilities: 

Project management and coordination of overall Data Management activities.
Participate in CRO selection and negotiation for data management portion of contract.
Coordinate and supervise activities of outsourced Data Management operations.
Collaborate with SAS programmers (internal and external) to resolve data quality issues.
Maintain existing data libraries (for completed trials) and data documentation.
Direct the design of clinical databases. Ensure standardization, efficiency and quality are met and maintained.
Ensure all SOPs and process guidelines are followed to ensure compliance with regulatory guidelines included in 21CFR Part 11.
Develop and implement standard clinical data quality procedures and related SOPs.
Review and approve clinical data management plan for each clinical trial.
Perform QC and QA audits on data, validated clinical systems CROs and department SOPs.
Perform and/or direct study database design, development and validation as needed.




Requirements

 Experience and Education (minimums):

BS or BA (life sciences preferred) or equivalent
Minimum of 5 years experience in Clinical Data Management or related industry experience
Oncology experience is preferable
SAS Viewer experience is a plus