Associate Director, Clinical Data and Technologies

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

Tango’s labs and offices are located at 201 Brookline Avenue, in the vibrant Fenway area of Boston, Massachusetts. 

Summary

Tango has an exciting new opportunity to join the Biometrics team as an Associate Director, Clinical Data & Technologies. In this role you will reporting to the Director, IRT Systems. You will be a subject matter expert at electronic Clinical Outcome Assessments (eCOA) and other clinical technologies from study start up through data generation, decommissioning, and documentation archival. Clinical technologies will encompass a spectrum of systems including but not limited to eCOA, IRT and Centralized imaging. This position will enable clinical data management and support clinical data issue resolution for these technologies, ensuring high-quality clinical data to support key initiatives. You will be forward-thinking about the needs of a clinical development operations organization and possess high attention to detail. You will maintain a collaborative outlook with the ability to pursue multiple options in parallel.

Your Role:

• You will serve as the eCOA and clinical technologies Subject Matter Expert for Tango’s clinical studies and programs
• Lead clinical technologies including planning, execution, and delivery of the clinical data activities on eCOA and clinical technologies, implementing secure procedures to initiate best practices and lead data management flow
• Demonstrate strong technical expertise to maintain high standards of data integrity, accuracy, reliability, efficiency and compliance with regulatory requirements
• Working closely with Clinical Data Management and Clinical Operations, assist with documentation and oversight of clinical data quality and timeliness such as tracking, KPIs, data management and monitoring
• Work collaboratively and cross-functionally to gather relevant requirements and utilize available resources to create the system design, provide subject matter expertise, and ensure expert and on-time system delivery and implementation as well as data quality standards are met
• Responsible for IRT vendor management, implementation project management, IRT requirements, and design including integrations with EDC and reporting systems, user acceptance testing, and maintenance
• Responsible for facilitation of IRT technical support, data changes; working with cross-functional stakeholders including Clinical Supplies, Clinical Operations, Biostatistics, and Clinical Data Management in order to achieve goals
• Responsible for UAT test case creation, oversee and facilitate signatures on documentation, and risk and impact assessment
• Responsible for the administration and uploading documentation to appropriate eTMF
• Deliver exceptional customer service and technical support to Clinical Operations, Biostatistics, Clinical Supplies, and Data Management
• Productively contribute to, or lead, process updates, cross-functional initiatives, standards documentation updates, and/or SOPs
• May serve as business or product owner for internal applications that are IRT adjacent, such as forecasting, enrollment planning, and/or centralized clinical inventory and distribution systems
• Support inspection readiness activities as needed
• Additional duties and responsibilities as required

What You Bring:

• Eight years of clinical supply systems experience in the pharmaceutical or biotech industry
• Bachelor’s degree in a science-based subject (advanced degree preferred)
• eCOA Subject Matter Expertise with an in depth understanding of clinical development process and regulatory frameworks governing eCOA solutions
• Hands-on Data Management experience of EDC, eCOA, IRT and Centralized imaging
• Experience with user requirement specifications/user test scripts with clinical data technologies
• Prior demonstration of creative, capable problem solving and innovation as it relates to integrations between clinical systems (eCOA, IRT, EDC, etc.) in a clinical research environment
• Prior engagement in activities that involve system development lifecycle to support the use of clinical technologies within a clinical study
• Ability to deal with time demands, incomplete information and prioritize tasks
• Technical excellence and solid technical skills across data platforms
• Working knowledge of ICH, GAMP, FDA, IRB/IEC and other applicable regulations/guidelines
• Demonstrated understanding of clinical research protocol requirements and appropriate reporting of clinical trial data
• Ability to work independently with a high level of attention and act with initiative to address issues
• Flexible and team-oriented with ability to manage multiple projects in a fast-paced environment
• Strong project management
• Excellent written and oral communication skills
• Demonstrated proficiency with MS Office, such as Outlook, Word, Excel, PowerPoint, and SharePoint

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.