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. Serve as the communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting. Data Management
Coordinate 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. Involvement in audits and inspections. Support 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 the 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). Review and approval of electronic data transfer (import/export) specifications. Quality Control
Perform database QC checks 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
Train 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). Strong organizational and managerial skills. Additional Information
Advance your career in clinical research and develop new skillsets whilst growing with the organization.
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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. Serve as the communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting. Data Management
Coordinate 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. Involvement in audits and inspections. Support 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 the 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). Review and approval of electronic data transfer (import/export) specifications. Quality Control
Perform database QC checks 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
Train 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). Strong organizational and managerial skills. Additional Information
Advance your career in clinical research and develop new skillsets whilst growing with the organization.
#J-18808-Ljbffr
