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) Specialist, Clinical Project
This individual will be part of the Clinical Operations team and requires a solid understanding of trial to provide key updates and metrics to guide the management of the trials.
- Liaise with CROs and third party vendors to ensure compliance with study protocol, local regulatory and institutional requirement
- Maintain and update internal study trackers
- Oversee site start-up and ongoing sites activities by tracking progresses.
- Generate and track key study metrics such as recruitment, patient statuses, performance and quality metrics for internal stakeholder review
- Assist with preparation of clinical protocols, amendments, informed consent forms, and other clinical research related documents
- Maintains sponsor trial and department documents
- Review site invoices and process payments accordingly
- Coordinate site contract reviews between relevant stakeholders
- Assist with review and reconcile vendor invoices
- Participate in periodic review of data in Electronic Data Capture
- Generate periodic clinical data management reports and metrics, such as but not limited to data entry reports and query resolution reports
- Assist with preparation and review of study/template Case Report Forms (CRF) and Completion Guidelines
- Bachelor’s Degree or Graduate Degree in a field of science or nursing, preferably biology, chemistry, pharmacy, or other field related to human study
- At least 2 years experience working in clinical trial operations, project management or related field.
- Experience in oncology, particularly immuno-oncology an advantage
- Proficiency in Microsoft Excel, Powerpoint, Word