Lead Data Manager – Clinical Trials

🕒 July 17

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Primary communication point for project teams and company departments with regard to clinical data management • Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting • 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: • Study documents review • Data Management plan and other project-specific guidelines and instructions development and review • Co-ordinate/perform user acceptance testing • Development of Data Validation Plan/Edit Check Specifications • Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues • Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data • Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues) • Database edits (paper CRF studies) • Manual CRF review (non-medical checks) • 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) • SAE reconciliation • Electronic data transfer (import/export) specifications review and approval • Liaison with Document Center with regard to maintenance of TMF and eTMF • 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 of Assistant Data Managers • Project-specific training of investigators and clinical team in CRF completion • Investigator Meetings preparation/attendance • Meetings and teleconferences organized by client/vendor preparation/attendance

🎯 Requirements

• College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities • At least 3 years of experience of full scope of data management responsibilities in global EDC studies • At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable) • Project data management experience is a plus • Organizational and managerial skills