Senior Manager, Clinical Data Management at Tango Therapeutics

Boston, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, OncologyIndustries

Requirements

BS with 5+ years of clinical data management experience in CRO, pharma, or biotech settings
Strong experience with Medidata Rave EDC systems and electronic trial master files (eTMF)
Demonstrated knowledge of ICH/GCP, FDA regulations, and clinical trial processes
Proficiency in industry data standards including CDISC, SDTM, and CDASH
Prior experience collaborating with CROs on clinical studies
Highly organized with excellent communication and interpersonal skills
Experience in small biotech environments highly preferred
Familiarity with data visualization or analytics tools such as R, SAS or elluminate
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
Ability to manage multiple projects in a fast-paced environment

Responsibilities

Serve as the lead data management representative on cross-functional study teams
Manage day-to-day clinical data management activities with CROs and vendors to ensure timely and accurate data capture
Develop, review, and maintain study-specific data management documentation, including Data Management Plans (DMPs), CRF Completion Guidelines, and Data Review Guidelines
Provide leadership and oversight for user acceptance testing (UAT) of eCRFs and associated edit checks
Guide and monitor data cleaning, discrepancy management, and data reconciliation activities with external vendors and internal stakeholders
Establish, review and monitor data quality metrics to ensure clean, consistent, and analyzable datasets
Partner with CROs to manage timelines and deliverables for data management activities
Contribute to database lock activities, ensuring audit readiness and data integrity
Maintain and ensure accuracy of study-specific trackers and metrics dashboards
Create and manage data deliverable timelines and tasks
Review and provide feedback on vendor data transfer agreements, transfers and reconciliation

Skills

Clinical Data Management

Data Management Plans

CRF Completion Guidelines

Data Review Guidelines

User Acceptance Testing

eCRFs

Edit Checks

Data Cleaning

Discrepancy Management

Data Reconciliation

CRO Management

Vendor Oversight

Tango Therapeutics

Develops targeted cancer therapies using synthetic lethality

About Tango Therapeutics

Tango Therapeutics develops targeted cancer treatments using the principle of synthetic lethality, which allows them to design drugs that kill cancer cells while leaving healthy cells unharmed. Their approach focuses on the interaction between genes, where the loss of both genes leads to cell death, but the loss of only one does not. This method enables them to create therapies that are more precise in targeting tumors. Tango operates in the oncology market, primarily serving healthcare providers and pharmaceutical companies interested in advanced cancer therapies. They collaborate with larger pharmaceutical firms, like Gilead Sciences, to co-develop their treatments, which helps in funding and speeding up the process of bringing these drugs to market. Tango's goal is to advance their pipeline of targeted immunotherapies through strong research and development efforts and strategic partnerships.

Cambridge, MassachusettsHeadquarters

2017Year Founded

$341.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Hybrid Work Options

Risks

Discontinuation of TNG348 due to liver toxicity may affect investor confidence.

Reliance on partnerships for financial support poses risks if partnerships change.

Intensifying competition in precision oncology could impact Tango's market share.

Differentiation

Tango leverages synthetic lethality to target cancer cells while sparing healthy ones.

Their focus includes counteracting tumor suppressor gene loss and immune evasion.

Strategic collaborations with pharma companies accelerate development and commercialization of therapies.

Upsides

Growing interest in synthetic lethality enhances Tango's innovative approach in oncology.

Recent $80 million financing strengthens Tango's financial position for future developments.

FDA clearance for TNG348 and TNG462 boosts Tango's clinical trial advancements.

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