(Senior) Manager, Clinical Data Management

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 Data Management

Responsibilities

The (Senior) Clinical Data Manager works primarily as a lead project data manager on a study team to provide data management (DM) support and perform functional sponsor oversight of CRO for one or more in-house or outsourced clinical studies with supervision as needed, as well as carry out various hands-on DM tasks as required. More specific responsibilities include:

  • Assist in providing Data Management CRO oversight to ensure quality, timeliness, and compliance of DM deliverable
  • Attend project meetings as DM functional team member
  • Review study protocol, case report forms (CRFs), data management plan (DMP), and other DM related study documents and provide inputs as required
  • Participate in study electronic data capture (EDC) system and electronic CRF setup activities and sponsor user acceptance testing (UAT)
  • Oversee data review and data cleaning activities including but not limited to generation and resolution of queries, review of edit checks and findings, AE/SAE reconciliation, and management of external data
  • Support study data cuts for interim analysis, clinical study report, presentations and manuscripts, database freeze, soft-lock, and final lock activities.

Requirements

  • Education background in life science or relevant area preferred
  • Minimum 3 to 5 years’ hands-on experience in biopharmaceutical clinical development setting required
  • Experience in DM tasks such as reviewing DM plan and other CDM documents, testing eCRF and EDC setup, defining and testing edit checks, reviewing study data, coding AEs and medications, generating and resolving DCFs, maintaining project timelines, preparing and performing database lock, etc
  • Knowledge of standard coding dictionaries MedDRA, WHO Drug, etc. and also best industry DM practices
  • Cross-functional teamwork and interpersonal skills
  • Effective oral and written communication skills