Senior Data Manager
At proClinical, we are seeking an individual to fill the role of Senior Data Manager, based in Fort Washington, PA.
- Participate in the review of Clinical research documents.
- Develop Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensure DMP is followed according to study design and requirements.
- Develop Case Report Form (CRF), electronic and/or paper.
- Develop database clinical trial data specifications.
- Lead EDC database (DB) specification process.
- Develop Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
- Reconcile electronic data transfers from vendor to Sponsor.
- Develop test scripts and execution logs for User Acceptance Testing (UAT).
- Coordinate UAT of eCRF build and validation documents.
- Track and maintain EDC and relevant clinical databases across allocated clinical trials.
- Perform training on study trial for EDC and create user guides.
- Ensure clinical data within EDC is in quality to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review, and or final database lock.
- Assist in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
- Coordinate the archiving of study databases and related documents.
- Perform close-out audit for closing of study trial in EDC or other clinical data management DBs.
- Assist in reconciling AE/SAE data in Safety DB and/or other Data Management DB.
- Assist and provide input into study and project level data analysis plan.
- Coordinate and communicate with DB vendors on consistent basis to address Clinical teams' requests, project plans, and/or eCRF development activities.
- Prepare and present data where necessary.
- All ad-hoc duties as assigned.
Skills And Qualifications
- BA in a science related field.
- 8+ years of data management and/or related experience in a medical device or pharmaceutical industry/company is preferred.
- Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Working knowledge of Clinical database applications such as EDC.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Estella Nchumuluh at (+1) 2679433657 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.