What are the responsibilities and job description for the Clinical Data Manager position at Signant Health?
Role Overview
The Clinical Data Manager is responsible for working with the Clinical Data Management team and other internal project team members to provide data management services for our customers to ensure on time and accurate deliverables. Responsibilities include providing data management guidance to internal project team members and customers; communicating with internal project team members and customers on all aspects of data management activities performed for a study; authoring data management documents; performing user acceptance testing on data management deliverables; and facilitating and verifying data clarifications and data changes.
Key Accountabilities/Decision Making & Influence
Collaborate across functional groups to address technical issues impacting quality, drive forward technical initiatives within Data Management
Provides data management guidance to internal project team members and customers
Communicates with internal project team members and customers on all aspects of data management activities performed for a study
Authors data management plans (DMP)
Authors data transfer specifications (DTS)
Performs user acceptance testing on reports specified in the DMP
Performs user acceptance testing on automated data checks programmed to support the data cleaning activities specified in the DMP
Reviews, makes decisions, and acts upon output from automated data checks
Facilitates risk assessments for mid-study changes
Verifies data extracts against the DTS
Provides proactive data monitoring per contractual obligations
Facilitates and verifies data clarifications and data corrections
Facilitates and verifies external data reconciliation
Contribute to the development and update of process improvements that reduce processing times, increase quality, mitigate operations risks, improve team performance, and meet departmental objectives and corporate objectives
Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget
Performs all work in accordance with documented Standard Operating Procedures (SOPs), Working Instructions and Best Practices
Assists in developing and improving Standard Operating Procedures (SOPs), Working Instructions and Best Practices
Knowledge, Skills & Attributes
BA/BS degree in a relevant field (Medicine, Statistics, Computer Science) or equivalent work experience
Strong verbal and written communication skills
Ability to complete high quality technical documentation
Demonstrate extreme attention to detail and organization in all aspects of work
Ability to quickly learn and apply new skills, procedures and approaches.
Demonstrated ability to meet very short deadlines & multi-task in an extremely fast-paced work environment with little direct supervision
Proven ability to work both independently and in a team-oriented environment, providing back-up support to team members & establishing/maintaining effective work relationships with co-workers within and across functional areas
Previously demonstrated proactive and positive approach to tasks and projects overall, as well as to the types of scheduling & process changes that are inherent in a fast-paced business
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