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.

Your role:

• You will manage the clinical data management partnership with clinical CROs for Tango’s clinical trials
• Provide oversight for fully outsourced clinical data management activities from RFP to final database lock by working effectively with CRO partners to develop and standardize data handling plans, data transfer specifications, metrics, and data review tools
• Develop and/or write the database design, edit checks, CRF completion guideline, and Data Management Plan for in-house data management activities ensuring CDASH and SDTM standards
• Work with cross functional team members to standardize data collection and reporting
• Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, specialty labs, etc.) to ensure that project timelines and goals are met effectively, and within budget
• Attend study team meetings to provide updates and issue resolution in terms of data collection through analysis
• Work collaboratively with cross functional team members to ensure clinical data is ready for early phase deliverables in stream
• Support a Tango eCRF library and database build configuration
• Additional duties and responsibilities as required

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
• At least three years of management experience in a clinical research environment, most of which should be in industry and preferably across therapeutic areas including oncology
• 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, eluminate 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.