Clinical Informatics Manager

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.

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

Summary  

Tango has an e xciting new opportunity to join the Biometrics team as Clinical Informatics Manager. In this role you will report to the Vice President, Data Management. You will be a subject matter expert at Centralized Imaging, 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:

Serve as the Central Imaging, 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 Centralized Imaging, 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

Partnering 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

Lead cross-functional collaboration to gather requirements, design systems, and deliver technology solutions on time, ensuring data quality and compliance standards are consistently met.

Responsible for implementation project management, including clinical data systems integrations with EDC and reporting systems. Aid in device management as needed

Oversee facilitation of clinical technologies technical support, data changes, data issue resolution; working with cross-functional stakeholders including Clinical Data Management, Clinical Operations and Biostatistics in order to achieve goals

Responsible for user acceptance testing oversight and documentation, including UAT test case creation, facilitating signatures on documentation, and risk and impact assessment

Responsible for the administration and uploading of documentation to appropriate eTMF

Enable and guide study teams by delivering exceptional customer service and technical support for daily use of clinical systems.

May assist with process updates, cross-functional initiatives, standards documentation updates, and/or SOPs

Support inspection readiness activities as needed

Additional duties and responsibilities as required

What You Bring:

7+ years of clinical systems experience in the pharmaceutical or biotech industry

Bachelor’s degree in a science-based subject (advanced degree preferred)

eCOA and/or Centralized Imaging Subject Matter Expertise with an in depth understanding of clinical development process and regulatory frameworks governing 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 and 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, team-oriented, 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.

#LI-Hybrid

 

Salary range

$144,800 — $217,200 USD