Responsibilities :
- To manage each of the data management projects to which assigned; provide leadership to the corresponding data management teams.
- To represent for all dealings with Sponsors with respect to the Data Management aspects of the projects to which assigned.
- To take responsibility for staff training for all projects to which assigned; both direct involvement in training and supervision of staff assigned to training.
- To liaise and collaborate with corresponding teams in other departments working on the same project.
- To ensure that all data management operations are conducted to SOPs; contribute to the ongoing revision / improvement of these SOPs.
- To create and review project specific documentation for assigned trials, the Data Management Plan and the Data Management File.
- To write specifications for the set-up and modification of database and edit check specifications for assigned projects.
- To write and validate Manual and SAS checks.
- To set-up processes for reconciliation and perform reconciliation of data from external sources ( Serious Adverse Events, IVRS, Central Laboratory).
- To perform verification and User Acceptance Testing of configured databases.
- To support and oversee all data cleaning activities for assigned projects.
- To specify and review SAS listings / SAS tables for assigned projects.
- To create and review CRF and eCRF completion guidelines, EDC system manuals and access instructions.
- To train others to make full and correct use of the company Data Capture systems, when used, for the collection of clinical data.
- To produce information / reports directly from the clinical database or via the appropriate procedure to request a new report from the appropriate department or vendor.
- To liaise with personnel at the sponsor company, or their designates, with Central Event Adjudication Committees (CEC) within clearly defined guidelines for matters concerning processing of data.
- To ensure that adequate QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects.
- To ensure timely database locks for all assigned projects.
- To participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings. Ensure that any recommendations are discussed and that solutions are incorporated.
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Requirements :
- Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry.
- years of experience within Clinical Data Management or associated field.
- Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
- Must be computer literate and numerate with a willingness to adapt to various computer systems.
- It is essential that the job holder works with close attention to detail and is questioning about the validity of the data being entered and has an ability to phrase data queries in an understandable and impartial manner.
- To have the ability to train new staff and to monitor their performance.
- Proven project delivery skills.
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