Associate Director, Clinical Data Management
Tango Therapeutics
5 hours ago
Remote friendly (Boston, MA)
United States
$152,000 - $228,000 USD yearly
Clinical Research and Development
Responsibilities:
- Lead the clinical data management partnership with CROs to ensure seamless execution of Tango’s clinical trials.
- Oversee fully outsourced data management activities from RFP through final database lock; standardize data handling plans, data transfer specifications, metrics, and data review tools.
- Develop and/or author key clinical data management documents (database design specifications, edit checks, CRF completion guidelines, and Data Management Plans) in compliance with CDASH and SDTM.
- Partner with cross-functional teams to standardize data collection and reporting processes to improve efficiency and data quality.
- Guide and monitor data cleaning, discrepancy management, and data reconciliation with external vendors and internal stakeholders.
- Lead oversight for UAT of eCRFs and associated edit checks.
- Establish, review, and monitor data quality metrics to ensure clean, consistent, analyzable datasets.
- Collaborate with internal/external stakeholders (CROs, software vendors, clinical development partners, specialty labs, etc.) to deliver on time and within budget.
- Participate in study team meetings with updates, issue resolution, and ensure data is collected, reviewed, and analyzed.
Qualifications:
- Bachelor’s degree in computer science or science-based subject; 8+ years of clinical data management experience in industry (cross-indication experience; EDC platforms such as Metadata Rave).
- 5–8 years leading clinical trial data management from study start-up through database lock within an industry sponsor (ideally oncology or rare diseases).
- Strong vendor management and oversight experience.
Skills (required/preferred):
- Strong technical skills across data platforms; programming experience preferred.
- Experience designing clinical trials using CDASH and SDTM.
- Collaboration with Biostatistics, Statistical Programming, and Pharmacovigilance.
- Understanding of FDA and ICH GCP guidelines for clinical trial data reporting.
- Regulatory GCP inspections/audits experience preferred.
- Experience with Spotfire, elluminate, or other data visualization tools.
- Ability to manage multiple projects in a fast-paced environment.
Benefits:
- Salary range: $152,000—$228,000 USD
- Lead the clinical data management partnership with CROs to ensure seamless execution of Tango’s clinical trials.
- Oversee fully outsourced data management activities from RFP through final database lock; standardize data handling plans, data transfer specifications, metrics, and data review tools.
- Develop and/or author key clinical data management documents (database design specifications, edit checks, CRF completion guidelines, and Data Management Plans) in compliance with CDASH and SDTM.
- Partner with cross-functional teams to standardize data collection and reporting processes to improve efficiency and data quality.
- Guide and monitor data cleaning, discrepancy management, and data reconciliation with external vendors and internal stakeholders.
- Lead oversight for UAT of eCRFs and associated edit checks.
- Establish, review, and monitor data quality metrics to ensure clean, consistent, analyzable datasets.
- Collaborate with internal/external stakeholders (CROs, software vendors, clinical development partners, specialty labs, etc.) to deliver on time and within budget.
- Participate in study team meetings with updates, issue resolution, and ensure data is collected, reviewed, and analyzed.
Qualifications:
- Bachelor’s degree in computer science or science-based subject; 8+ years of clinical data management experience in industry (cross-indication experience; EDC platforms such as Metadata Rave).
- 5–8 years leading clinical trial data management from study start-up through database lock within an industry sponsor (ideally oncology or rare diseases).
- Strong vendor management and oversight experience.
Skills (required/preferred):
- Strong technical skills across data platforms; programming experience preferred.
- Experience designing clinical trials using CDASH and SDTM.
- Collaboration with Biostatistics, Statistical Programming, and Pharmacovigilance.
- Understanding of FDA and ICH GCP guidelines for clinical trial data reporting.
- Regulatory GCP inspections/audits experience preferred.
- Experience with Spotfire, elluminate, or other data visualization tools.
- Ability to manage multiple projects in a fast-paced environment.
Benefits:
- Salary range: $152,000—$228,000 USD