Senior Clinical Data Manager

Tango Therapeutics

New York (NY)

Hybrid

USD 145,000 - 217,000

Full time

33 hours ago
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Job summary

Tango Therapeutics seeks a Senior Manager, Clinical Data Management to lead data management for assigned trials, ensuring high-quality, inspection-ready data from startup to closeout. You will oversee outsourced DM activities, align with cross-functional teams, and support regulatory submissions and development objectives.

Responsibilities include overseeing EDC/IRT/eCOA builds, review of DM deliverables, and ensuring adherence to ICH-GCP, FDA and EU CTR requirements, CDISC standards, and data

Qualifications

  • Bachelor's degree in a related field.
  • 5+ years of Clinical Data Management experience.
  • Experience leading Data Management activities in regulated environments.
  • Experience managing outsourced Data Management activities.
  • Experience with IRT/eCOA configurations and vendor oversight.

Responsibilities

  • Act as Data Management lead within the Clinical Trial Team and provide oversight across the lifecycle.
  • Oversee CROs and external vendors, ensuring data activities meet requirements, timelines, budgets, and regulations.
  • Ensure timely delivery of inspection-ready data through EDC, IRT, eCOA activities and data management processes.
  • Review and approve key Data Management deliverables (CRF/eCRF, IRT, eCOA specs, data transfer specs).
  • Establish data quality metrics and KPIs to ensure integrity and regulatory compliance.

Skills

Clinical Data Management
CRO oversight
EDC
eCOA
IRT
CDISC (CDASH/SDTM)
Regulatory knowledge (ICH-GCP, FDA, EU

Education

Bachelor's degree in Computer Science, Life Sciences, Mathematics, Health Sciences, or related field

Tools

EDC systems
IRT
eCOA

Job description

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

The Senior Manager, Clinical Data Management serves as the Data Management lead for assigned clinical trials and is responsible for the planning, oversight, execution, and delivery of data management activities from study startup through database lock and study closeout. The role provides sponsor oversight of outsourced data management activities, ensures high-quality and inspection‑ready clinical data, and collaborates with cross‑functional stakeholders to support trial execution, regulatory compliance, and clinical development objectives.

Your Role:
  • Serve as the Data Management representative within the Clinical Trial Team (CTT) and provide oversight of Data Management activities throughout the clinical trial lifecycle
  • Provide sponsor oversight of CRO and external data vendors, ensuring Data Management, IRT and eCOA activities and deliverables are executed in accordance with study requirements, quality standards, timelines, budgets, contractual obligations, and regulatory requirements
  • Ensure timely delivery of complete, accurate, reliable, and inspection‑ready clinical data through effective oversight of outsourced Data Management activities, including EDC, IRT and eCOA system build, validation and maintenance, data collection, data cleaning, medical coding, external data integration and reconciliation, database/system lock, and submission readiness
  • Review and approve key Data Management deliverables, including CRF/eCRF, IRT, eCOA specifications, edit checks, Data Management Plans, CRF completion guidelines, data transfer specifications, external data reconciliation plans, and other study‑specific documentation
  • Establish and monitor data quality metrics, KPIs, and data review strategies to ensure data integrity, consistency, and compliance throughout the study lifecycle
  • Lead oversight of external data integrations, transfers, reconciliations, and vendor‑managed data streams to ensure completeness, quality, and regulatory compliance
  • Partner with CTT, CRO and external vendors to support effective planning, integration, review, and reporting of clinical trial data
  • Identify data‑related risks and issues and lead the development, implementation, and monitoring of mitigation and contingency plans
  • Participate in audits, inspections, and inspection readiness activities and ensure timely assessment, response, and resolution of Data Management‑related findings
  • Contribute to regulatory submissions, health authority responses, and other regulatory deliverables, as required
  • Support the development and implementation of Data Management standards, processes, technologies, and continuous improvement initiatives
What You Bring:
  • Bachelor's degree in Computer Science, Life Sciences, Mathematics, Health Sciences, or related field
  • 5+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, or CRO industry
  • Experience leading Data Management activities for clinical trials in a regulated environment
  • Experience managing outsourced Data Management activities and providing vendor oversight
  • Experience managing clinical systems (incl. IRT/ eCOA) configurations and implementations, enhancements, integrations, and technology vendors;
  • Experience leading User Acceptance Testing (UAT)
  • Experience supporting database build, data cleaning, external data integrations, medical coding, database lock, and submission readiness activities
  • Experience working within global clinical development organizations
  • Experience supporting audits, inspections, and inspection‑readiness activities preferred
  • Experience using electronic data capture (EDC) platforms and clinical data technologies
  • Oncology clinical development experience preferred
  • Strong knowledge of Clinical Data Management processes and the clinical trial data lifecycle
  • Strong knowledge of ICH‑GCP, FDA regulations, EU Clinical Trial Regulation (CTR), data integrity principles, and other applicable regulatory requirements
  • Knowledge of CDISC standards, including CDASH and SDTM, and associated clinical data requirements
  • Proficiency with EDC systems, IRT, eCOA, and related clinical technologies
  • Knowledge of medical coding dictionaries, including MedDRA and WHODrug
  • Familiarity with data visualization, analytics, and reporting tools
  • Strong understanding of risk‑based quality management and critical‑to‑quality (CtQ) principles
  • Strong vendor management and sponsor oversight capabilities
  • Strong project management, organizational, and prioritization skills
  • Excellent collaboration skills with cross‑functional stakeholders, including Biostatistics, Statistical Programming, Pharmacovigilance, Clinical Operations, and Regulatory Affairs
  • Strong analytical thinking, problem‑solving, and decision‑making capabilities
  • Excellent written and verbal communication skills

#LI-Hybrid

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

$144,800 - $217,200 USD

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self‑identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Tango Therapeutics’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service‑connected disability.

A "recently separated veteran" means any veteran during the three‑year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

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