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Job Description
OBJECTIVES/PURPOSE
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Drive operational planning and execution activities to enable Clinical Data Management (CDM) delivery across the portfolio.
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Provide operational and strategic CDM outsourcing leadership and acts as the primary focal point across the department for ensuring vendors perform according to agreed requirements in order to deliver on time, within budget, and quality expectations.
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Establish and manage CDM vendor governance framework(s) to ensure high quality delivery of CDM services.
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Oversee CDM strategic, change management and continuous improvement initiatives.
ACCOUNTABILITIES
Provides CDM operational and strategic outsourcing leadership:
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Creates and manages a comprehensive CDM vendor operational and governance framework including Key Performance Indicator (KPI) and quality metrics, portfolio status updates, resourcing algorithms, and allocation strategies to ensure high quality on time and within budget delivery according to Takeda business requirements and enable achievement of Takeda Future Fit objectives.
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Strengthen and align existing CDM vendor relationships and governance and, in collaboration with relevant stakeholders, leads CDM evaluation of new potential vendors.
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Manages FSP vendor staff allocation, onboarding, and offboarding processes across CDM TAU (therapeutic area unit) groups.
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Ensure vendors are aligned to Takeda processes and requirements and lead the operationalization of DM outsourced activities.
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Supports the development of tools and processes to enable effective vendor oversight,
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Facilitates CDM review of provider SOPs, processes and key documentation, as applicable.
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Collaborates with CDM Process Excellence, CDM Compliance and Quality Innovations, and the CDM leadership team to determine areas of focus for vendor engagement and improvement.
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Collaborates with Takeda Partnership Engagement and Takeda Procurement on vendor activities and governance for CDM.
Leads CDM business operations activities:
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Manage and monitor CDM departmental budget planning and PO/invoice tracking, in conjunction with the Head of CDM and CDM leadership team.
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Develop and manage resourcing tools to optimize timely and accurate CDM resource forecasting and allocation to Takeda portfolio studies.
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Manage requests and allocation of CDM staff to non-portfolio projects and initiatives.
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Represent CDM in applicable cross-functional and corporate initiatives.
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Manage CDM playbook, roadshow, and other branding materials to ensure consistent messaging of the CDM mission and vision.
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Provides CDM LT meeting support and development of department wide media and communications.
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Provides leadership and support necessary for the design, development, operation, execution, and improvement of operations, systems, processes or projects to achieve CDM strategies, goals and objectives.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
Education and Experience
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BS/BA required preferably in a health-related, life science area or technology-related fields, or equivalent combination of education, training and experience.
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Preferred 8 plus years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
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Preferred 3 years of line management experience or equivalent.
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Preferred 3 years experience directly managing clinical data management vendors and managing vendor relationships at the portfolio/operational level.
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Preferred business operations and budget management experience.
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Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
Special Skills/Abilities
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Advanced knowledge of office software (Microsoft Office).
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Experience with project planning & management.
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Strong knowledge of relational databases and experience using multiple clinical data management systems.
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Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
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Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
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Experience adhering to functional budget and providing timely updates to manager regarding additional, potential spend or cost savings.
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Strong knowledge of CDISC standards, SDTM and/or TA-specific standards preferred. Experience developing internal data standards and mapping of medical concepts is ideal.
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Advanced knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology, and nature of disease processes.
ADDITIONAL INFORMATION
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This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
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Base Salary Range: $143,500-205,0. Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
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The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
Massachusetts – Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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