Clinical Research Delivery Lead I - Markham, Canada - Everest Clinical Research-Can

Everest Clinical Research-Can
Everest Clinical Research-Can
Verified Company
Markham, Canada

2 weeks ago

Sophia Lee

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Sophia Lee

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Description

verest 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 a Clinical Research Delivery Lead for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Accountabilities

  • Perform document epublishing for CSRs and other clinical/regulatory documents to ensure that the final product meets specific document publishing requirements and timelines.
Document publishing activities include, but are not limited to the following:


  • Rendering the completed final Word document to PDF.
  • Acquiring all documents or appendices from the Sponsor and Everest personnel.
  • Creating hyperlinks and bookmarks and ensuring they have appropriate destinations and properties.
  • Lead the QC teams for the timely completion of linebyline checks of statistical listings against Case Report Forms (CRFs) and/or source datasets, for other departmental teams, ensuring timely and errorfree deliverables by following up on findings until resolution.
  • Perform a lead role in the timely completion of tables, listings and graphs (TLG) assembly packaging into Word and PDF format for other departmental teams.
  • Perform regulatory submission activities for our clients in compliance with company SOPs, working practices, and regulatory guidelines.
Activities include, but are not limited to, the following:


  • Performing document publishing of submission files to ensure compliance with Client and regulatory agency esubmission requirements.
  • Performing QC procedures on finalized submission documents to confirm acceptability of document and file format and metadata.
  • Assisting with tracking document status in the submissionspecific inventory file. Preparing submissionspecific approval forms.
  • Uploading finalized documents into eCTD submission software and compile submission.
  • Performing QC review of submissions complied by others prior to export, including but not limited to, QC checks of external hyperlinks between documents in the submission software system.
  • Validating and exporting submissions and preparing electronic media.
  • Developing and using checklists to standardize and ensure high quality throughout the esubmission process.
  • Performing quality assurance for regulatory submissions using eCTD format for Investigational New Drugs (INDs), New Drug Applications (NDAs), and Biologics Licensing Applications (BLAs).
  • Act as a lead medical writer in the preparation of clinical documents such as clinical study protocols, Clinical Study Reports (CSRs: full, abbreviated, or synoptic), Investigator's Brochures, Development Safety Update Reports (DSURs), patient narratives, manuscripts, posters, and abstracts. Ensure that appropriate QC checks have been performed on the medical writing deliverables.
  • May serve as the DMC Secretary and perform hands on administrative tasks for assigned projects, according to Everest's SOPs.
These tasks include, but are not limited to, the following:


  • Writing the committee Charter and its amendments and circulating for their review, finalization, and signoff by the committee and Sponsor.
  • Serving as the liaison between the committee and the sponsor.
  • Planning, scheduling, and coordinating all committee meetings, producing meeting minutes, and assisting the DMC Chair with the Recommendations Letter, according to the Charter.
  • May assist with the identification, recruitment, and engagement of committee members, including contract negotiations, consultant agreements, and administration of honorarium payments.
  • May assist with coordinating the preparation of the committee Data Reports by
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