The Clinical Data Manager (DM) is responsible for the coordination and delivery of Data Management contracted services on assigned projects.
This includes meeting internal and external sponsor requirements according to time, quality, scope and budget parameters. The DM is the primary point of contact for Data Management on a project, for internal project team members, sponsors, and external data vendors.
The DM presents project-related training, and may provide technical guidance and direction to team members.
Duties & Responsibilities
- Serves as the primary Data Management interface for internal project team members, sponsor representatives, third party CROs, and external data vendors.
- Ensures the timely initiation, conduct, and completion of Data Management activities on clinical trials.
- Leads a sub-team of Data Management staff members assigned to a project.
- Tracks Data Management timelines for assigned projects and ensures that all applicable Data Management team members are aware and on target for deliverables.
- Authors the Data Management Plan (DMP), outlining all data management responsibilities.
- Authors the Data Transfer Agreement (DTA) with third party external data vendors
- Oversees UAT of clinical data systems (EDC, eCOA, IWRS) to be implemented on a project.
- Conducts project-specific training throughout the course of the project, as needed.
- Attends and presents at client bid defense meetings.
- Attends and presents at project meetings as required.
- Oversees the completion of a comprehensive data review of clinical data.
- Ensures medical coding is performed in a timely manner
- Ensures DM documentation is audit-ready and filed appropriately at all times.
- Coordinates all activities in preparation for database lock, including Data Review Meeting.
- Oversees the production of status or progress reports, listings, and other output as required during the course of the project
- Monitors budget and scope of work for contracted DM services throughout the duration of the project, identifying out of scope or budget activities, and collaborating with the project manager when out of scope documentation and costs are needed.
Desired Experience & Qualification
- Bachelor’s degree in a related field of study or equivalent combination of education and work experience
- Minimum 2 years experience in clinical research
- Demonstrated experience in a lead role
- Knowledge of ICH/GCP standards, 21 CFR Part 11.
- Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
- Effective verbal and writing skills; English + local language, if relevant.
- EDC experience; knowledge and experience with Rave desired
Method of Application
How to apply: Synteract South Africa
All applicants who meet the above criteria will be required to undergo job related assessments to establish suitability for placement, this includes a verification of qualifications.