OBJECTIVES: (Briefly summarise the overall purpose of the position. Objectives should
be written in 3 – 4 bulleted statements).
Responsible for timely and high quality data management deliverables supporting the Takeda portfolio.
Establish asset and study level strategies and services, including excellence in the application of standards.
Responsible for data management oversight of the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget
Conducts oversight of data management activities performed by Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives. Activities include from protocol synopsis through database release and submission
Contributes to the management of vendor partnerships to maximize effectiveness and maintain budgets.
Provides and enables solutions for complex problem solving that align with the Takeda values.
Serves as a clinical data management expert and provides guidance on CDISC standards.
ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 – 10 bulleted task statements should be identified).
Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially in support of key decision points and regulatory submissions.
Contributes influential leadership in collaboration with other Takeda Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.
Provides input to functional governance with Takeda’s strategic suppliers. Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams.
Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics.
Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents
Oversees the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
Represents function in external professional initiatives and organizations such as SCDM, CDISC, DIA, etc. to identify industry best practice and increase the visibility of Takeda.
Participates and represents function in formal inspections and audits as requested.
Other duties as assigned
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
BS/BA required preferably in a health-related, life science area’
Minimum of 8years data management and/or drug development experience.
Proven track record of strong project management skills and experience managing data management activities for large drug development programs
Experience with all phases of development and at least 2 therapeutic areas.
Ability to handle multiple development programs simultaneously.
Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance.
Good understanding of CDISC standards, and experience implementing standards.
Strong knowledge of clinical study reporting requirements including SAS programming.
Advanced knowledge of office software (Microsoft Office).
Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
Advanced knowledge of FDA and ICH regulations and industry standards and quality control principles.
Experience in medical coding in the pharmaceutical/biotechnology industry including knowledge of coding tools.
Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes.
Able to influence without authority
Excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo
Pragmatic and willing to drive and support change
Is comfortable with ambiguity
Embody a culture of continual improvement and innovation; promote knowledge sharing