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.
Senior Manager, Clinical Documentation (New Jersey)
- 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.
- Archiving duties
- 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).
- Pharmaceutical experience
- Clinical trial essential documents/GCP experience
- Relevant and current procedures for Document Management
- Electronic Document Management