About Tessa Therapeutics
Tessa Therapeutics is a clinical-stage cell therapy company focused on the development of autologous and off-the-shelf, allogeneic therapies to treat cancer. Tessa’s Virus-Specific T cell (VST) technology platform harnesses the body’s potent anti-viral immune response and has shown early efficacy and a strong safety profile against solid tumors in clinical trials.
Tessa is building a portfolio of innovative, next-generation therapies through combination approaches and other novel immuno-oncology technologies. This portfolio includes a rapidly growing clinical pipeline that target a wide range of cancers, including nasopharyngeal carcinoma, cervical cancer, oropharyngeal cancer, lung cancer, breast cancer, bladder cancer, head and neck cancer, and lymphomas.
Tessa has built up robust operational and supply chain capabilities to successfully deliver cell therapy treatments to a large patient pool worldwide. Together with the Company’s academic, clinical, and commercial research partners, Tessa has created a fully-integrated approach to the treatment of cancer with immunotherapy.
Our global team of over 200 employees is passionate about bringing life-saving cancer treatments to patients all over the world. If this excites you too, explore our job opportunities and see if there’s a match.
For more information on Tessa, please visit www.tessatherapeutics.com.
Manager, Clinical Data Management
Associate Director, Clinical Operations and Data Management
- 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 datasets and final production of datasets 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
- Develop internal CDM guidelines and quality processes to ensure final databases are accurate
- Represent CDM and effectively communicate requirements, strategy, timelines, and deliverables at internal cross functional team meetings and meeting with external vendors
- Bachelor’s or Master’s degree in scientific, biological, statistical, computer science, or related field
- At least 5 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
- Data programming experience such as SAS preferred.
- Keep up with the latest technologies, regulatory guidelines and literature on data management practices for the biotech/pharmaceutical industry preferred
- Experience implementing CDASH/CDISC data standards preferred