Senior Data Manager at PSI CRO

Bucharest, , Romania -

Full Time

Start Date

Immediate

Expiry Date

29 Apr, 26

Salary

0.0

Posted On

29 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Management, Clinical Trials, EDC Development, Database Lock, Quality Control, SOP Development, Audits, Training, Communication, Project Management, Data Collection, Data Cleaning, Reconciliation, Medical Coding, CRF Design, Team Leadership

Industry

Pharmaceutical Manufacturing

Description

Company Description PSI is a leading Contract Research Organization with 30 years experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. 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.

Responsibilities

The Senior Data Manager will oversee all data management activities in large, complex studies, ensuring quality and timely delivery. Responsibilities include coordination of data management activities, database lock, and training junior team members.