Associate Director, Clinical Data Management

Tango Therapeutics • Boston, MA

26d

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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 This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 101-250 employees