Senior Data Manager
- Reference: JLS SDM
- Location: Pontypridd
- Salary: £45000 Negotiable
- Type: Full time
- Start: ASAP
You are an experienced Senior Data Manager with a strong background in Clinical Research who is passionate about drug development and seeking a challenging and rewarding career in a process focused role. You will be looking to move into a fast paced Phase I environment, setting up and maintaining clinical studies within Oracle InForm.
You will be expected to take responsibility for leading all data management activities for assigned clinical studies, being responsible for all aspects of the study from eCRF Design, review and testing, all aspects of data review and database lock procedures. You will have excellent knowledge of data management processes and standards and demonstrates excellent attention to detail.
You will be the main point of contact for internal and external clients and have previous experience attending and presenting at face to face meetings. In addition, you will provide support to the Principal Data Manager, having experience with mentoring and training to junior members of the department and managing the work flow and ensuring timelines are achieved. You will ensure that departmental managers are kept fully informed of all project activities.
You will hold a degree or equivalent in any science subject, ideally having a proven track record as leading multiple clinical trials. You will have excellent communication and time management skills and have the ability to prioritise your workload to meet deadlines with minimal support from management.
You are team focused and can motivate other members of the project team to meet timelines and project goals. You will have a proven record for effective relationship building with sponsors and colleagues, as well as strong management skills.
You are confident in presenting at face to face meetings, and in your presentations to sponsors. You have high standards for the quality of material presented.
Qualifications, Skills and Experience
- JOB PURPOSE
The Senior Data Manager will act as the lead for assigned studies, being responsible for all aspects of clinical trial Data Management procedures. The Senior Data Manager is the main point of contact for internal and external clients and will be responsible for attending and presenting at face-to-face meetings.
The Senior Data Manager will provide support to the Principal Data Manager, providing mentoring and training to junior members of the department (as required) and managing the work flow and ensuring timelines are achieved.
Other tasks as assigned by their manager with appropriate training.
- PRINICPAL DUTIES
1. Performs and oversees Data Management tasks in studies using EDC or paper CRFs.
2. Data Management point of contact for allocated studies.
3. Providing support in the management of the Data Management team.
4. Provides mentoring to junior colleagues.
5. Codes CRF/eCRF data using industry dictionaries.
6. Prepares Data Management documentation for allocated studies, including Data Management Plans, eCRF User Guides and Data Transfer Plans.
7. Specifies and validates the electronic data validation checks that are to be performed on allocated studies.
8. Performs database lock procedures.
9. Attends study team meetings throughout the life of the study to proactively communicate issues that may affect the Data Management of the study.
10. Liaises with internal and external suppliers for receipt of electronic data.
Just Life Sciences
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