Document Quality Control and Management Specialist, Toronto/Markham, Ontario, Canada Location
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 a committed, skilled, and customer-focused individual to join our winning team as Document Quality Control and Management Specialist for our Toronto/Markham, Ontario, Canada location.
The Document Quality Control and Management Specialist is responsible for performing quality control (QC) procedures on clinical trial documents, and assisting with document assembling, publishing and archival activities. This individual will work closely with multidisciplinary study teams in all aspects of document quality control and document management activities. These documents include but not limited to clinical study protocols, statistical tables, listings, and graphs (TLGs), statistical reports, clinical study reports, integrated summaries, manuscripts, abstracts, etc. These procedures are performed timely and in accordance with Everest’s SOPs and quality standards.
- Perform data verification (QC) on statistical programming outputs against data source such as patient case report forms or other information provided. Report discrepancies found from the QC procedure.
- Electronically assemble and publish statistical TLGs.
- Collect, scan, and electronically assemble and publish clinical trial and regulatory documents.
- Perform QC checks on electronically assembled and published documents, such as Clinical Study Reports and other regulatory submission documents. These checks include but not limited to verifying accuracy and completeness of the following elements within the documents: Table of Contents, bookmarks and hyperlinks, references, numbers reported in the in-text tables and body text, abbreviation list, document pagination, and other QC checks defined by the Medical Writers or regulatory submission specialist. If the documents are scanned from paper versions, the QC checks will include verification of the quality of the scanned documents.
- Perform consistency review of document formats, styles and overall layout according to a document style guide. May assist in editing a document with regard to formats, styles, and overall layout.
- May perform document electronic publishing activities including bookmarking and hyperlinking of documents, document cleaning, and header/pagination stamping, etc.
- Assist with hardcopy and electronic archiving of relevant documents in the appropriate repository, including electronic trial master files, according to established document control and archiving practices.
Qualification and Experience:
- Minimum of a B.Sc. degree in life sciences with at least 2 years of experience in a pharmaceutical clinical trial environment is required.
- Detail-oriented, customer- and quality-focused.
- Strong verbal and written communication skills.
- Excellent proficiency with Microsoft Office Suite and Adobe Acrobat.
- Excellent interpersonal and teamwork skills.
- Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments.
- Experience in document management of clinical and regulatory documents is desirable.
- Experience with trial master file requirements and document archiving for clinical studies will be an asset.
- Experience in electronic document assembling and publishing in a pharmaceutical clinical research setting will be an asset.
How to Apply:
Please send your application along with cover letter to [email protected]
To find out more about Everest Clinical Research and to review other opportunities, please visit our website 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.