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 exciting new opportunity to join the Biometrics team as Sr. Manager, Clinical Data Systems. 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
Skills Required
- 7+ years of clinical systems experience in pharmaceutical or biotech
- Bachelor's degree in a science-based subject
- Advanced degree
- eCOA and/or Centralized Imaging subject matter expertise
- Hands-on data management experience with EDC, eCOA, IRT and Centralized Imaging
- Experience creating user requirement specifications and user test scripts (UAT)
- Experience with system development lifecycle for clinical technologies and integrations
- Working knowledge of ICH, GAMP, FDA, IRB/IEC and applicable regulations/guidelines
- Strong project management skills
- Excellent written and oral communication skills
- Proficiency with MS Office (Outlook, Word, Excel, PowerPoint) and SharePoint
- Technical competence across clinical data platforms and ability to ensure data integrity
What We Do
Tango Therapeutics is a biotechnology company discovering and developing novel medicines targeting cancer vulnerabilities to deliver transformational new therapies for patients. Tango was launched in 2017 with a $55 million Series A investment from Third Rock Ventures. The company has established a robust product engine that leverages advances in DNA sequencing and CRISPR-based target discovery to generate breakthrough medicines that have the potential to provide deeper, more sustained benefit than today’s targeted therapies, and extend the benefit of available immuno-oncology agents. Tango Therapeutics is focused on three areas of drug development, each in well-defined patient populations currently lacking effective treatment options, and each with hallmarks of cancer that have not been targeted yet. These include: loss of tumor suppressor gene function; multiple oncogenic drivers; and immune evasion. What fuels each of Tango’s programs is an increasingly sophisticated ability to utilize synthetic lethality - the interaction between two genes that causes cell death when both are inactivated. In cancer cells, one of these genes is inactivated by mutation; the other will be inactivated by a drug. This approach leaves normal cells largely unaffected, with the potential to greatly enhance anti-tumor efficacy and reduce associated toxicity. Tango’s success will be driven by its depth of understanding of the genetic subtypes of cancer, and corresponding insights into novel drug targets and combinations uniquely relevant to each subtype. By shaping discovery efforts in this way, Tango has the potential to reach the clinic quickly, and with a clear plan for identifying the patients most likely to benefit from each new treatment, an approach that could increase both speed and probability of success in translating novel target discoveries into transformational new medicines for patients.
