Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
The Senior Data Manager will be responsible for oversight of all data management activities in large, complex studies.
Communication
- Provide general oversight on all Data Management activities on large complex global studies
- Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting
Data Management
- Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables.
- Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:
- Reviews and approvals, escalation point and troubleshooting
- Involved in audits and inspections
- Supporting with SOP development and process improvements
- Provide input into Proposals, Budgets and Bid Defense meetings
- Clinical database lock
- Coordination and supervision of processing, dispatch and archiving of CRFs/queries
- Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
- Development of CRF completion guidelines
- Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
- Electronic data transfer (import/export) specifications review and approval
Quality Control
- Database QC checks performance and documentation
- Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
- Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management
Training
- Training junior members of the team
- Project-specific training of investigators and clinical team in CRF completion
Qualifications
- College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
- Significant experience of full scope of data management responsibilities in international EDC studies
- Experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
- Organizational and managerial skills
Additional Information
Advance your career in clinical research and develop new skillsets whilst growing with the organization.
Top Skills
What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
