Senior Clinical Data Manager — Remote

Everest-Clinical-Research; Markham; Hybrid; CAD 90,000 - 130,000; Full time

Job summary

Everest Clinical Research in Canada is seeking Senior Clinical Data Managers for Toronto/Markham on-site or remote from a home-based office anywhere in Canada. You will lead data management activities, manage client relationships, and ensure timely delivery of data deliverables across trials.

Responsibilities include designing CRFs, writing DMPs, overseeing QCs, coordinating with vendors, training staff on EDC, and supporting audits and inspections.

Qualifications

• Bachelor's or Master's degree in health and/or pharmaceutical sciences, physical/biological, or chemistry fields.
• At least 5 years of experience in pharmaceutical clinical trial data management or at least 2 year of experience as a Clinical Data Manager II, with demonstrated knowledge, experience and ability to perform to meet high quality standards and high level of customer satisfaction.
• Demonstrated an in-depth understanding of clinical trial data management concepts, processes and procedures, relevant issues related to or impacting clinical data management, as well as pharmaceutical clinical trial regulations, industry guidance, conventions and standards
• Demonstrated a strong leadership in clinical data management activities and a desire to excel in leading data management projects.

Responsibilities

• Lead Data Management Activities, Perform Training and Client Relationship Management
• Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
• Is the primary contact person for day to day data management activities, and is the person ultimately responsible for all data management deliverables for assigned projects.
• Is the primary contact person for communication and discussion of topics related to data management timelines and deliverables; request for out of scope tasks; first line contact for technical or procedural issues.
• Is responsible for planning and implementing data management timelines and deliverables; and is responsible for providing database and data management activities status reports; contributes to the overall project planning, progress tracking and reporting.
• Assist with study-level resource planning and management, including the review of team members’ timesheet reports.
• Assist in performing client relationship management activities. Participate in project bid defense meeting when required.
• Perform training on electronic data capture (EDC) system, dataflow and quality control processes to clinical trial personnel.
• Provide training to new data management personnel on data management processes and procedures. Perform QC review of work performed by less experienced data management personnel.
• Assist in generation of project Work Orders and Amendments.
• Assist in management of dataflow from and performance of Third Party Vendors (Non-CRF data vendors).
• Participate in project kick off meeting, investigators meeting, and regular project management team meeting.
• Provide support to client audits and regulatory inspections. Follow up on audit findings.
• Create and maintain clinical trial Data Management Study Binders.

Skills

Data management

EDC systems

Client relations

Project leadership

Training delivery

Education

Bachelor's or Master's in health/pharmaceutical sciences

Tools

EDC system

Database design

Job description

Everest Clinical Research in Canada is seeking Senior Clinical Data Managers for Toronto/Markham on-site or remote from a home-based office anywhere in Canada. You will lead data management activities, manage client relationships, and ensure timely delivery of data deliverables across trials.

Responsibilities include designing CRFs, writing DMPs, overseeing QCs, coordinating with vendors, training staff on EDC, and supporting audits and inspections.