Senior Clinical Data Managers, Toronto/Markham, Ontario, Canada or Little Falls, New Jersey, USA Locations (on-site or remote)
Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.
Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Little Falls (Greater New York City Area), New Jersey, USA, and Shanghai (Pudong Zhangjiang New District), China. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.
Quality is our backbone, customer-focus is our tradition, flexibility is our strength...that’s us…that’s Everest.
To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Senior Clinical Data Managers for our Toronto/Markham, Ontario, Canada or Little Falls, New Jersey, USA locations (on-site or remote).
I. Perform and Lead Data Management Activities
- 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.
- Plan and implement 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. Is the primary contact person for request for out of scope tasks; first line contact for technical or procedural issues.
- Perform study-level resource planning and management, including the review of team members’ timesheet reports.
- Participate in project kick off meeting, investigators meeting, and regular project management team meeting.
- Develop and maintain Data Management Project Plan (Plan). Document deviations from the Plan, log and report issues, and follow up on their resolutions.
- Design and review case report forms (CRFs/eCRFs). Develop and review Case Report Form Completion Instructions. Generate and review annotated Case Report Forms.
- Design and review Clinical Trial Source Document templates and completion instructions when required.
- Develop and maintain data validation specifications.
- Coordinate database design process and lead User Acceptance Testing (UAT).
- Manage the process of database modifications after go-live.
- 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.
- Develop and maintain Data Quality Review Plan (DQRP). Coordinate with programmers to complete the programming and validation of the listings and summary tables as specified in the DQRP.
- Review data, issue and resolve queries.
- Perform Serious Adverse Event reconciliation.
- Assist in resolving medical coding discrepancies.
- Perform management of dataflow and quality of data from the Third Party Vendors (Non-CRF data vendors).
- Perform database soft lock and hard lock activities.
- Assist in performing client relationship management activities. Participate in project bid defense meeting when required.
- Assist in generation of project Work Orders and Amendments.
- Cooperate and assist internal and external audits on assigned projects.
- Maintain and prepare final archival of data management documentation relevant to the assigned projects, and assist the corporate archivist in assembling and archiving such documentation.
II. Perform as a Technical and Process Leader in Assigned Departmental or Corporate Level Projects
- Manage the EDC CRF to PDF CRF conversion process for generating regulatory submission-ready CRF packages.
- Lead effort in the further development and implementation of a “real time” data and trial information portal/dashboard with standard and custom reports covering the following: reports for data managers and safety data reviewers, reports on site performance, risk factors and scores, patient profiles, reports for data trending and pattern recognitions, etc.
Qualifications and Experience:
- A Bachelors’ 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.
How to Apply:
Please send your application along with cover letter to the applicable country email address:
To find out more about Everest Clinical Research and to review other opportunities, please visit our WEB site at www.ecrscorp.com
We thank all interested applicants, however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.