Associate Director, Clinical Data Management

Posted 25 Days Ago
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Boston, MA, USA
In-Office
152K-228K Annually
Senior level
Biotech
The Role
Lead clinical data management for Tango's outsourced trials from planning through database lock. Oversee CRO partnerships, data standards (CDASH/SDTM), database design, edit checks, UAT, data quality metrics, vendor oversight, and cross-functional collaboration to ensure timely, high-quality clinical datasets.
Summary Generated by Built In

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

Reporting to the Vice President, Biometrics, the Associate Director of Clinical Data Management will be responsible for leading the clinical data management processes across Tango’s clinical trials. This will include clinical trial planning through data generation and database lock. This position will initiate best practices and lead clinical data management process flow as well as support the oversight of data management vendors, data transfers and data handling. This role is ideal for someone who thrives in a dynamic environment, excels at collaboration, and is passionate about ensuring high-quality clinical data to drive impactful decision-making.


Your Role:

  • Lead the clinical data management partnership with CROs, ensuring seamless execution of Tango’s clinical trials
  • Provide oversight for fully outsourced data management activities from RFP to final database lock, working closely with CROs to develop and standardize data handling plans, data transfer specifications, metrics, and data review tools
  • Develop and/or author key data management documents, including database design specifications, edit checks, CRF completion guidelines, and Data Management Plans, ensuring compliance with CDASH and SDTM standards
  • Partner with cross-functional teams to standardize data collection and reporting processes, enhancing efficiency and data quality
  • Guide and monitor data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholders
  • Provide leadership and oversight for user acceptance testing (UAT) of eCRFs and associated edit checks
  • Establish, review and monitor data quality metrics to ensure clean, consistent, and analyzable datasets
  • Collaborate with internal and external stakeholders (CROs, software vendors, clinical development partners, specialty labs, etc.) to ensure projects are delivered on time and within budget
  • Participate in study team meetings, providing updates, addressing issues, and ensuring data is effectively collected, reviewed, and analyzed

What you bring:

  • Bachelor’s degree in computer science, or a science-based subject with at least 8 years of clinical data management experience in industry, with experience across indications and EDC platforms like Metadata Rave
  • 5-8 years of experience leading the data management of clinical trials, from study start up through database lock, within an industry sponsor, ideally focusing on oncology or rare diseases
  • Strong vendor management and oversight experience
  • Solid technical skills across data platforms; programming experience preferred
  • Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology
  • Cross collaboration proficiency with other related functions such as Biostatistics, Statistical Programming, and Pharmacovigilance
  • Understanding of FDA and ICH GCP guidelines to ensure appropriate reporting of clinical trial data
  • Experience in regulatory GCP inspections/audits preferred
  • Experience with Spotfire, elluminate or other data visualization software
  • Ability to manage multiple projects in a fast-paced environment


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.



Salary range
$152,000$228,000 USD

Top Skills

Metadata Rave,Edc,Ecrf,Cdash,Sdtm,Spotfire,Elluminate
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The Company
HQ: Boston, Massachusetts
157 Employees
Year Founded: 2017

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.

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