Senior Manager, Clinical Data Management

Company Background

Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies.

We are looking for highly motivated and enthusiastic individuals who are interested to be part of our team.

 

Job Position
Senior Manager, Clinical Data Management

Job Description

This individual will work closely with the Clinical Trial team to provide direction and oversight for Clinical Data Management (CDM) deliverable. This Individual will liaise with Contract Research Organizations (CROs) and/or external vendors in all aspects of data management for assigned trial(s).

Responsibilities

  • Develop internal CDM guidelines and quality processes to ensure final databases are accurate
  • Set Key Performance Indicators and drive performance within the department
  • Provide oversight and participate in study set-up and initiation procedures such as CRF design, database design, edit check design/review, and DMP (data management plan) review
  • Perform review of clinical trial protocols, with focus on potential CDM issues and cross-study data consistency
  • Oversee all CDM activities performed by CROs, from study start-up, through database lock
  • Ensures the proper collection, management, and storage of clinical trial data (according to regulatory requirements)
  • Manage the incorporation of external data sets and final production of data sets for regulatory submission
  • Perform data validation and quality checks, and initiate corrective and preventive actions as indicated
  • Summarize data to reflect progress of clinical trial(s) and quality of data and sites on periodic and as required
  • Participate in other activities and meetings to support the Clinical Trial Team as needed
  • Represent CDM and effectively communicate requirements, strategy, timelines, and deliverable at internal cross functional team meetings and meeting with external vendors

Requirements

  • Bachelor’s or Master’s degree in scientific, biological, statistical, computer science, or related field
  • At least 10 years of clinical trial data management experience
  • Working knowledge of Electronic Data Capture and other trial-associated database systems
  • Proficiency with Microsoft Office (Excel, Word, Outlook, Power Point)
  • Experience in Industry-sponsored Oncology trials an added advantage