Overall purpose of the position:
To manage TASK clinical trials data through review, computerization, cleaning, and auditing of clinical data in compliance with standard operating procedures, client guidelines and regulatory guidelines. 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.
Key performance areas (KPA’s) & 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.
- Works with overall project team (i.e., Customer, Project Management, Clinical, DM Ops & Biostatistics as needed) in defining DM timelines/deliverables for the project.
- Leads a sub-team of Data Management staff members assigned to a project.
- Assists other team members in training and developing data management expertise.
- 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) and quality control procedures to be implemented on a project.
- Coordinates production, review and authorisation of the CRF design.
- Conducts project-specific training throughout the course of the project, as needed.
- 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
- Understands and complies with core operating procedures and working instructions.
- Communicates ongoing project deliverables to DM Ops and ensures adequate progress is being made toward deliverables.
- A B.Sc. degree in bio-medical or bio-statistical; or relevant data management experience
- Knowledge of ICH-GCP with a strong interest in clinical research
- Experience in working with databases
- Professional use of the English language; both written and verbal
- Clinical trial systems knowledge e.g., Clindex or Clintrial
- Advanced computer skills
Key Personal Inherent Characteristics
- Delivers high performance.
- Excellent communicator – able to clearly convey information both verbally and in writing.
- Able to drive quality by displaying ability to clarify and reduce complex issues to simple solutions.
- Able to anticipate problems and resolve problems before they occur.
- Recognize recurring issues and analyse their causes in order to reach a solution.
- Excellent planning & organising skills with the ability to work systematically and sequentially.
- Personal effectiveness and the ability to work in a pressurised environment.
- Maintain good relationships with colleagues and customers.
- Able to adapt to the changing needs and requirements of the position.
Area: Parow, Cape Town
Contract Type: Permanent
APPLICATIONS CLOSE: 20 April 2021
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