Document Quality Control Management Specialist I

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 Document Quality Control Management Specialist for our Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in the Canada in accordance with our Work from Home policy.

JOB ACCOUNTABILITIES:

- Assist with the creation or update of resumes and JDs for Everest employees/consultants based on company templates and source documentation.
- Perform QC review of resumes/JDs prepared by other individuals, to ensure that the final product meets specified requirements.
- Coordinate and liaise with all parties involved for the creation, review, update, and sign-off of resumes/JDs.
- Maintain and update the file tracking log in real time with documents’ status to ensure it is up-to-date and audit-ready at all times.
- File physical and/or digital records of resumes/JDs within the appropriate repositories.
- May assist with the creation and update of resume/JD document templates.
- May assist the medical writing functional area in other tasks as needed, such as:
- Perform data verification (QC) on statistical programming outputs against data source such as patient case report forms or other information provided. Report discrepancies found during the QC procedure.
- Perform QC review of clinical documents written by Medical Writers, including QC checks for protocol-related information, accuracy of in-text numbers and source references, and consistency of document styles and formats.
- Perform bookmarking and hyperlinking of case report forms (CRFs) intended for regulatory submission, and/or perform QC review of CRFs completed by others.
- May assist the document control and archiving functional area in other tasks as needed, such as:
- Assist with hardcopy and electronic archiving of clinical study documents.
- Assist with quality control review of archived documentation from the various functional areas of Everest.

QUALIFICATIONS:

- Bachelor’s degree in health science, physical, or biological fields.
- Education or experience must demonstrate the ability to work independently.
- Ability to handle multiple projects and/or changing priorities.
- Proven ability to use Microsoft Word for professional document preparation and Microsoft Excel to develop tracking documents and perform simple calculations.
- Ability to maintain confidentiality for personal and business information.
- Excellent organizational and time management skills, acting with a proactive attitude and with the ability to work on one’s own initiative.
- Excellent interpersonal and teamwork skills; detail-oriented, customer
- and quality-focused.

We thank all interested applicants, however, only those selected for an interview will be contacted.

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