(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

Job Description

 This individual will work primarily as a lead project data manager on a study team to provide data management (DM) support and perform functional sponsor oversight of external vendors for multiple in-house or outsourced clinical studies with minimal supervision, as well as carry out various hands-on DM tasks as required.

Responsibilities

  • Supervise and liaise CROs, EDC vendors, and specialty laboratories to ensure quality, timeliness, and compliance of DM deliverables.
  • Attend project meetings as DM functional team member.
  • Contribute to DM aspect of study protocol, study case report forms (CRFs), data management plan (DMP), and other DM related study documents.
  • Participate in study CRF design, 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 8-10 years (Sr. Manager, CDM) or 5-8 years (Manager, CDM) overall experience in biopharmaceutical clinical development setting required, hands-on DM experience required, experience in oncology desired.
  • Well-rounded experience in managing CROs as well as various hands-on DM tasks such as authoring/reviewing DMP and other CDM documents, designing CRFs, testing eCRF and EDC setup, defining and testing edit checks, reviewing study data, coding AEs and medications, generating and resolving queries, maintaining project timelines, preparing and performing database lock, etc.
  • Knowledge of standard coding dictionaries MedDRA, WHO Drug, etc., best industry DM practices, and pertinent regulatory requirements required.
  • Cross-functional teamwork and interpersonal skills.
  • Effective oral and written communication skills