Associate Director, Clinical Data Management (REMOTE)

Takeda
Published
November 30, 2022
Location
Massachusetts - Virtual
Category
Other  
Job Type
Work Setting
In-office

Description

As the Associate Director of Clinical Data Management, you are responsible for timely and high-quality data management deliverables supporting the Takeda portfolio.  You will report to the Director of Clinical Data Solutions. You are responsible for conducting oversight of Data Management activities at the program, group of programs, and/or portfolio level - as performed within Takeda or by Strategic Partners, CROs, or other 3rd Party Vendors - to ensure they meet obligations as described in ICH-GCP and Takeda's Scope of Work, maximize effectiveness and maintain budgets.

You will provide and enable solutions for complex problem-solving that align with the Takeda values.  You will establish Program(s) or Portfolio level strategies and services, and are accountable for managing vendor partnerships to maximize effectiveness and maintain budgets.

You will provide data management expertise and capability supporting global development programs and post-marketing registration and non-registration studies.

Key Accountabilities

  • Lead data management activities for in-house and outsourced studies, and manage staff responsible for performing those activities.
  • Manage vendor oversight activities across global development programs. Represent data management function on the Clinical Sub-team, ensuring aligned expectations between the CRO and Takeda for all data-related deliverables, especially to support decisions and regulatory submissions.
  • Provide input to functional governance with Takeda's strategic suppliers. Partner with appropriate team members to resolve issues escalated by the vendor and teams.
  • For studies where data management activities are conducted within Takeda, leads clinical trial data collection set-up, data review, and database lock as follows:
  • Works with other departments to complete the set up of EDC and other study data collection tools such as IRT, ePRO, and eCOA.
  • Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, and database lock plans.
  • Leads data review, including query management, and leads activities required for interim and final database locks.
  • Oversees the above activities at the program and portfolio level.
  • Participate in preparing function for submission readiness and may represent a function in a formal inspection or audit.
  • Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
  • Accountable for the functional resource coordination to ensure support for Submission Working Group activities.
  • Achieve major data management deliverables with other departments, including the Therapeutic Area Units, Clinical Operations, Pharmacovigilance, and Statistics. This includes securing and coordinating functional resources to support all studies within scope to ensure delivery for implementing data capture tools, Data processing, coding, and validation.
  • Manage external Data Management budgets (in collaboration with Clinical Operations TA Leads) to ensure accuracy, understand trends in variances, and support continuous improvement in forecasting.
  • Be a process expert for operational and oversight models.
  • Maintained SOPs, process maps, templates, and timelines to support operational and oversight models.
  • May prepare metrics to support the function's KPIs.
  • Represent function in external professional projects and organizations such as SCDM, CDISC, and DIA to identify industry best practices and increase the visibility of Takeda.
  • Define and Lead functional Continuous Improvement projects, providing strategic direction and identifying deliverables that meet timelines, budget, and our company, departmental or functional requirements.
  • Ensure the quality of the data in each database delivery, and the quality of other data management deliverables
  • Champion and adopt technology improvements and tools for use in clinical data management processes.
  • Ensure compliance with own Learning Curricula, corporate, and GXP requirements.

Educational Qualifications

  • Bachelor’s Degree or international equivalent preferred, or equivalent combination of education, training, and experience.

Experience:

  • 8 or more years of data management and drug development process with expertise in the data management function.
  • Experience managing vendor relationships and alliance partnerships with at least four years of experience in this area.
  • Minimum 3 years of line management experience or equivalent.
  • Experience in project management and managing data management activities for large drug development programs.
  • Experience with all phases of development in one or more therapeutic areas is preferred.
  • NDA/CTD Experience preferred.
  • Experience in data management best practices, standards, library development, and maintenance.
  • Experience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Experience in the broad drug development process with expertise in the interfaces with the data management function.
  • Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

Special Skills/Abilities

  • Knowledge of relational databases and experience using multiple clinical data management systems.
  • Knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
  • Knowledge of general medical coding in the pharmaceutical/biotechnology industry, including knowledge of medical dictionaries, coding tools, and coding governance models.
  • Ensure adherence to functional budget, and update the manager regarding additional, potential spend, or cost savings.
  • Experience with CDISC standards, SDTM, and TA-specific standards preferred. Experience developing internal data standards and mapping Medical Concepts is ideal.
  • Experience with general medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology, and the nature of disease processes.

What Takeda Can Offer You

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • Health & Wellness programs, including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs
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