Associate Clinical Data Manager
Location: Morrisville, North Carolina, United States
Requisition Number: 3108
Position Title: Associate Clinical Data Manager
SUMMARY: To assist the Data Manager providing support and technical expertise in the management and processing of clinical data, within assigned projects to ensure that they are executed in an efficient, accurate and timely manner to the Sponsor’s satisfaction.
Tasks may include but are not limited to:
- To assist the Data Manager in each of the data management projects to which assigned, including reporting trial progress and outstanding issues.
- To attend or deputise for the Data Manager at study update meetings or calls with the trial sponsor.
- To assist in 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 WCT departments working on the same project.
- To ensure that all data management operations are conducted to WCT SOPs; contribute to the ongoing revision/improvement of these SOPs.
- To assist the Data Manager in the creation of project specific documentation for assigned trials, i.e. the Data Management Plan and the Data Management File.
- To assist the Data Manager to prepare database and edit check specifications.
- To assist the Data Manager with the creation and validation of Manual and SAS checks.
- To assist the Data Manager with the reconciliation of data from external sources (e.g. Serious Adverse Events, IVRS, Central Laboratory).
- To perform verification and User Acceptance Testing of configured databases.
- To assist the Data Manager in all data cleaning activities.
- To review SAS listings/SAS tables.
- To create CRF and eCRF completion guidelines, EDC system manuals and access instructions.
- To assist the Data Manager in the production of 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 as determined by the Data Manager for matters concerning processing of data.
- To assist the Data Manager with the performance of QC checks (including spot checks) and Database Quality Assessments on the clinical databases of assigned projects.
- To assist the Data Manager with all aspects of database lock.
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
OTHER SKILLS AND ABILITIES:
- The job holder 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
- Educated to degree level (preferably Life Science), Nursing qualification, or relevant industry experience
Employment Type: Regular
Community / Marketing Title: Associate Clinical Data Manager
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.