Lead Data Manager – Clinical Trials

🔥 12 hours ago

🇨🇦 Canada – Remote

💵 $130k - $150k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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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

• Manage all data management activities in large, complex clinical studies under general supervision • Perform data management activities for small to medium-sized projects under minimal supervision • Serve as the primary communication point for project teams and company departments regarding clinical data management • Communicate with clients and vendors regarding data management aspects and reporting • Coordinate EDC development, data collection, cleaning, reconciliation, database lock, final integrated database development, and final data management deliverables • Review study documents and develop or review data management plans and project-specific guidelines • Coordinate or perform user acceptance testing • Develop data validation plans and edit check specifications • Coordinate and supervise data entry and provide feedback on data quality • Perform automatic and manual data validation, discrepancy review and resolution, and query generation and resolution • Handle non-CRF electronic data, including receiving, archiving, loading, review, and reconciliation • Perform database edits and manual CRF review • Coordinate clinical database lock and CRF/query processing, dispatch, and archiving • Provide input into CRF and data collection form design and review CRFs for accuracy and protocol adherence • Code medical data and review coding dictionaries and listings where applicable • Perform SAE reconciliation and review electronic data transfer specifications • Liaise with the Document Center regarding TMF and eTMF maintenance • Perform and document database quality-control checks • Support internal, client, and third-party audits and resolve Data Management audit findings • Train Assistant Data Managers and provide project-specific training to investigators and clinical teams • Prepare for and attend investigator meetings, client/vendor meetings, and teleconferences

🎯 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 with the 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 experience preferable • Project data management experience is a plus • Organizational and managerial skills

🏖️ Benefits

• Remote work available • Career advancement opportunities • Opportunity to develop new skillsets • Growth within the organization