Join Our Team

Senior Clinical Data Manager

Here at Tizona Therapeutics, we value Patients First!
With this goal in mind, Tizona develops next-generation immunotherapies.

The successful development of immunotherapies represents one of the most important and exciting breakthroughs in cancer. Despite the recent progress in the field of immuno-oncology, existing immunotherapies are only effective in a relatively small number of patients and types of cancer – a limitation that we hope to overcome.  
 
Tizona’s therapies are designed to modulate the activity of immunosuppressive cells by targeting the cell types and biological mechanisms responsible for immune suppression in the tumor microenvironment. 
 
General Position Overview:

The Senior Clinical Data Manager role is responsible for all aspects of the clinical trial Data Management (DM) Lead for assigned clinical studies

Responsibilities:

  • Serves as an active member of Clinical Study Teams (CST)
  • Works with other functions to develop timelines and ensure that clinical data management deadlines are met
  • Oversees DM CROs as applicable
  • Works with vendors such as central laboratories in support of timelines and data-related deliverables
  • Ensures laboratory data, if applicable, and associated lab normal ranges are reviewed and reconciled
  • Defines eCRF and edit check specifications as necessary to support data collection and analyses required by the protocol
  • Works closely with database builders during programming of EDC databases, edit checks and reports
  • Drives and performs User Acceptance Testing (UAT) activities for clinical trial database build and modifications
  • Develops study-specific eCRF Completion Guidelines
  • Creates and follows study-specific Data Management Plans
  • Creates and maintains data management documentation
  • Ensure data cleaning activities as specified in the Data Validation Specifications and Data Management Plan
  • Works with the appropriate coding group to ensure medical terminology coding is applied to assigned clinical studies
  • Helps design listings in support of clinical and medical review of data
  • Identifies and troubleshoots operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from other project team members
  • Trains other personnel on eCRFs and EDC, as needed
  • Coordinates with cross-functional team members on serious adverse event reconciliation
  • Provides feedback on draft protocols, Statistical Analysis Plans, CSRs, and other documents as required
  • May participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities
  • Other duties as assigned

 

Qualifications:

  • Proficient computer skills, including Microsoft Office applications
  • Ability to work in cross-functional team-oriented environments
  • Understanding of ICH and regulatory environment as it pertains to data management
  • Experience with SDTM/CDASH
  • Strong project management skills
  • Excellent written, verbal, and organizational skills
  • Must be detail-oriented
  • Minimal travel, approximately 1-2 times per year
  • Writes clearly and informatively
  • Able to read and interpret written information

Key Competencies:

  • Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time
  • Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values
  • Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan
  • Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality
  • Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully
  • Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others
  • Adaptability – Able to adapt to changes in the work environment
  • Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others

 

Education and Experience Requirements:

  • Bachelors and/or combination of related experience in clinical, scientific, or healthcare discipline
  • 5+ years of experience in clinical data management in the pharmaceutical/biotechnology industry


Tizona Therapeutics is an Equal Opportunity Employer. We value diversity and are committed to providing employees a workplace free of discrimination and harassment. All employment decisions are based on qualifications, merit and business needs.

Apply for this Position