Senior Manager, Clinical Documentation (New Jersey)

About Tessa Therapeutics

Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.

Tessa’s clinical pipeline derives from  two innovative cell therapy platforms; CD30 Chimeric Antigen Receptors (CD30-CARs) and Virus-Specific T cells (VSTs). Our lead candidate comprises autologous CD30 CAR-T cell therapy targeting classical Hodgkin lymphoma (cHL) and CD30+ non-Hodgkin lymphomas.

Tessa is also developing a novel, allogeneic platform technology, as a new approach to traditional cell therapy. By combining the unique properties CD30-CARs and VSTs, the platform holds potential for the creation of next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa’s state-of-the-art GMP cell therapy manufacturing facility will open in early 2021, and will substantially enhance in-house production capabilities. Tessa is focused on rapidly and reliably providing safe, effective treatment options for patients.

Job Position

Senior Manager, Clinical Documentation (New Jersey)

Job Descriptions

  • Manages development, maintenance, and continuous improvement of Document Management systems.
  • Drives education of Document Management and controls across Clinical Operations.
  • Determines and/or implements actions related to document control as a result of changes in Regulatory requirements or policies.
  • Performs quality checks of clinical documents throughout the life of a trial (start-up to close-out) and escalates quality issues to the Clinical Project Manager (CPM).
  • Supports the preparation and management of key clinical documents prior to hand-off to Regulatory, as applicable.
  • Performs quality control (QC) of documents as assigned.
  • Tracks and enforces SOP training within Clinical Operations.
  • Assists in the development and maintenance of Clinical Operations SOPs.
  • Assists with Good Clinical Practice (GCP) audits and supports Quality Assurance (QA) in audits for document control and compliance.
  • Manages Clinical Operations document templates.
  • Interacts with Contract Research Organizations (CROs) and third party service providers regarding document management activities.
  • Assists the CPM in the quality oversight of TMFs outsourced to CROs, including the review and QC of trial-related plans and Essential Documents.
  • Assists in the maintenance of TMFs (internally and externally).
  • Supports QA and Information Technology (IT) with the Electronic Document Management Systems (EDMS), including training of Clinical Development staff on system functionality
  • The CDM will also cover the role of an archivist:
    • Archiving duties
      • Manages the Archive Room at Tessa Therapeutics and oversees the clinical documents (i.e.TMFs) stored in the Archive Room at Tessa Therapeutics.
      • Responsible for archiving of all Clinical Development Legal documents, both electronically and in paper.
      • Ensures archived documents/materials are registered systematically and stored properly, as well as protected against loss, modification, and damage.
      • Ensures inventories are complete and maintained.
      • Ensures no unauthorized access to the Archive Room at Tessa Therapeutics.
    • External Archiving Vendor(s)
        • Acts as point of contact for any external archiving vendor(s) and coordinates the shipment/retrieval and reconciliation of clinical documents/materials.

Requirements

  • Minimum Bachelor’s Degree in Life Sciences, related field, or equivalent job experience. Typically a minimum of 6+ years of progressively responsible experience in Regulatory Affairs, IT and/or documentation management.
  • Systematic and structured personality.
  • Demonstrated ability to work cooperatively and productively with others.
  • Ability to work independently in a changing environment.
  • Ability to meet deadlines on multiple assignments/projects.
  • Must be able to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations, European requirements, and company operating procedures, processes, policies, and rules.
  • Working knowledge of word processing and database management programs.
  • Working knowledge of electronic publishing and submission ready standards (e.g. Electronic Common Technical Document (eCTD), including process and document instructions).

Required Training

  • Pharmaceutical experience
  • Clinical trial essential documents/GCP experience
  • Relevant and current procedures for Document Management
  • Electronic Document Management