Director, Clinical Data Management

Location
Menlo Park, CA
Posted
Sep 10, 2021
Ref
1747335
Required Education
Bachelors Degree
Position Type
Full time

 

JOIN US!

Adicet Bio, Inc. is a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors and T cell receptor-like antibodies to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. For more information, please visit our website at http://www.adicetbio.com.

 

DIRECTOR, CLINICAL DATA MANAGEMENT

 

Overview:

The Director, Clinical Data Management will be responsible for performing all Data Management activities. He/she will participate as an active member of a multi-disciplinary study execution team to plan, lead and execute the Data Management tasks required for phase 1-2 studies.

The Director, Clinical Data Management must have a broad, fundamental knowledge of the data management process and should be able to perform most required tasks with minimal guidance.

 

Specific Responsibilities:

  • Leader of data management for Adicet’s sponsored clinical trials. Candidate should require minimal guidance in day-to-day performance.
  • Represent data management at study executive team meeting.
  • Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
  • Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design.
  • Be able to perform a thoroughly detailed review of eCRF data requirements and create one if need be.
  • Interact with CRAs, programmers, study operations lead in designing eCRFs and creating the annotated eCRF and CRF completion guidelines.
  • Lead the development of data edit check specifications and data listings.
  • Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company processes.
  • Able to resolve EDC system issues with team members.
  • Develop or lead the development of a Data Management Plan for a clinical study.
  • Able to review and provide feedback to the clinical team on other study documents Statistical analysis plans and vendor specifications.
  • May provide training on the EDC (Medidata Rave) system and/or eCRF Completion. Guidelines at Investigator Meetings and to internal and external study team members as needed.
  • Perform reconciliation of data from external data sources against the clinical database.
  • Lead database upgrades/migrations including performing User Acceptance Testing.
  • Perform database lock and freeze activities per company SOPs.

 

Essential requirements:

  • At least 5 years' experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA-regulated environment, including study lead experience.
  • At a minimum, Bachelor's Degree required in the scientific/healthcare field.
  • Must have good project management skills and a proven ability to multitask.
  • Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Strong written and verbal communication skills.
  • Experience in working with oncology studies and early phase studies.
  • Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications.
  • Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.

 

Benefits:

Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.

Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.