Director - Clinical Data Services

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology – it is all we do – combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking – we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients.

Position Summary:

This position is responsible for planning, tactical implementation and reporting of activities in the Data Management, Data Analytics, and Biostatistics & Programming departments for clinical research trials. This position oversees operational functions from database development through final statistics delivery, closely integrating with other departments and vendors. This position reports to the Head of Clinical Operations.

Essential Functions:

• Directly oversee and provide strategic management for the Data Management, Data Analytics, and Biostatistics & Programming departments as they provide data solutions for TD2 Clinical Department.

• Support data solutions for other TD2 departments, such as Nonclinical, Translational Medicine, and Regulatory.

• Review trial contracts and provide input to ensure accurate scope and budgeting of data-related activities.

• Participate in monthly revenue recognition activities by accurately reporting completed work and completing appropriate revenue trackers and/or systems.

• Continually evaluate and oversee the implementation of fully validated data systems needed to stay current with industry technology development, Sponsor demands and department efficiencies.

• Effectively prepare annual department budgets and communicate technology needs and strategies to grow the Data Services business.

• Direct the development, evaluation, and on-time reporting of Clinical Data, including but not limited to, data collection, cleaning, analysis, biostatistics and statistical programming, clinical study reports (CSR), FDA reports, abstracts, and manuscripts.

• Ensure staff produce clean and valid clinical trial data for delivery to Sponsors through involvement in all phases of global clinical trial processes from trial start up to final CSR delivery.

• Proactively communicate with TD2 team members and Sponsors to establish department policy and deliver on Sponsor requirements.

• Coach and guide department managers in the sourcing, selection, and onboarding of new Data Services employees.

• Ensure department managers maintain staff time reporting and utilization information per trial and share with senior management monthly to aid in determining data resources.

• Oversee development of department training materials and training of Data Services personnel.

• Maintain accuracy of TD2 controlled documents related to Data Services, creating new controlled documents as needed.

• Compile and provide standard data-related metrics as needed for decision making purposes.

• Represent TD2 during quality audits related to data service activities.

• Participate in Sponsor and bid defense meetings as requested.

• Perform other related duties as assigned.

Job Requirements:

• Minimum Bachelor’s degree (preferred in a health science field)

• Minimum 15 years of experience leading and managing teams

• Data services experience in a contract research, biotechnology or pharmaceutical setting

• Experience in Phase 1 and 2 oncology research trials

Required Specialized/Technical Skills:

• Knowledge in all aspects of clinical trial research, including FDA, GCP/ICH guidelines, CDISC/CDASH, SDTM standards and 21 CFR part 11

• Strong knowledge of the data service aspects of clinical drug development in Phase 1 and 2 oncology clinical trials

• Working knowledge of data tools and platforms such as electronic data capture systems, data dashboards, R, Python, SAS, and Cloud platforms.

• Demonstrated skill with establishing and documenting standard processes by which project tracking data is collected, updated and reported to the project team

• Strong supervisory and management skills, including ability to train and lead the work of others

• Financial acumen to develop annual budgets, review staff utilization, perform revenue recognition, and other related financial tasks

• Excellent communication, written and interpersonal skills, as well as planning and organizational skills

• Strong ability to perform individually and as a part of a team

• Client focused approach to work

• Strong Microsoft Office suite computer skills

• Strategic thinking, contingency planning, problem-solving and dispute resolution skills

• Ability to quickly find common ground and solve problems

TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran’s status, gender, sexual orientation, gender identity, or gender expression.

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