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 and 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) and data transfer specifications (DTS)
Performs user acceptance testing on reports specified in the DMP and 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 and provides proactive data monitoring per contractual obligations
Facilitates and verifies data clarifications and data corrections as well as external data reconciliation
Contributes 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
Possesses an analytical mindset and can easily observe patterns and trends that facilitate decision making.
Performs all work in accordance with documented Standard Operating Procedures (SOPs), Working Instructions and Best Practices and assists in developing and improving Standard Operating Procedures (SOPs), Working Instructions and Best Practices
Enhances the CRF Bracket business model by institutionalizing business processes, implementing best practices and templates, and seeking ways to work more efficiently
Communicates effectively within a multi-disciplinary project team to complete assigned tasks on time and within budget
Participates in special data-related projects as needed
Assist with other departmental initiatives and projects as required
Knowledge, Skills & Attributes
BA / BS degree in a relevant field (Medicine, Statistics, Computer Science) or equivalent work experience
Technical aptitudes and ability to complete high quality technical documentation. Ability to understand and work with HTML as well as different types of clinical databases.
Demonstrate extreme attention to detail and organization in all aspects of work. Previous project management experience is an advantage.
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.
Proficient in Access, Excel, and other office software technologies and applications.
Proven ability to handle multiple competing priorities in a fast-paced work environment with minimal direct supervision.
Strong verbal and written communication skills
Familiarity with 21 CFR Part 11 or experience in a regulated environment
3+ years of professional experience in the clinical trials data management field
Familiarity with data management best practices (GCP, GDPR, MHRA)
Familiarity with EDC systems