Data Management Expert
Proclinical is currently recruiting for a Data Management Expert of Early Clinical Development for a pharmaceutical company located in Annapolis, MD. Successful candidate will be responsible for oversight of the delivery of high-quality clinical data management via external partners. To maintain a constant awareness of trends/changes in external DM strategies and technologies and advise management on areas of improvement.
- Data management vendor and appropriate documentation oversight.
- Data management expertise in supporting strategic, operational and standards aspects of Data Management.
- Review, assess and manage DM delivery of relevant performance measures and drive continuous improvement.
- Strategic input to DM activities within and across therapeutic areas and ensure study teams utilize data collection standards.
- Lead, coordinate and ensure transparency and consistency of project, study and partner activities including providing partners with project planning information (scheduling of the studies, volumes, timelines etc.).
- Provide input into the DM related activities associated with regulatory inspections/audits in liaison with Clinical Quality Assurance.
- Work with external partners providing input into the production of the service orders and study costs for data management services where needed.
- Specialist in TA specific data capture and standards (Oncology, respiratory and cardiovascular) and CDISC standards.
- Provide leadership to the delivery of components of technical programming and information for a project.
- Identify opportunities to improve the methodology and provide practical solutions for problems.
- Support DQM's and any other members within ECD as required.
Skills and Requirements:
- Bachelor's degree in the life science, related subject or relevant experience.
- Extensive experience from within the pharmaceutical industry or clinical research organization.
- Demonstrated comprehensive knowledge and experience of aspects of Data Management
- Excellent Communication skills
- Comprehensive knowledge of clinical data standards.
- Comprehensive knowledge of database structures and of capturing and storing clinical information.
- A collaborative mind-set.
- The ability to drive innovations.
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 Felix Hook at (+1) 646-367-2617 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.
Proclinical Staffing is an equal opportunity employer.