Senior Lead Data Manager

Senior Manager, Clinical Data Management

The Senior Manager Clinical Data Management is responsible for timely and high quality data management deliverables supporting the client portfolio. They are responsible for conducting oversight of Data Management activities at the project or program level - as performed within the client or by Strategic Partners, CROs or other 3rd Party Vendors - to ensure they meet obligations as described in ICH-GCP and the Scope of Work, maximize effectiveness and maintain budgets. The Senior Manager Clinical Data Management provides and enables solutions for complex problem solving that align with the client values. They establish Project or Program level strategies and services, and are responsible for the management of vendor partnerships to maximize effectiveness and maintain budgets. The Senior Manager Clinical Data Management serves as an expert for clinical data management, whether directly or by way of managing or mentoring other [junior] data management staff. They will lead cross-functional team members to perform proper Data Reviews, and provides guidance on CDISC standards.

Key Accountabilities

* Responsible for leading data management activities for in-house and outsourced studies; may manage staff responsible for performing those activities.

* 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.

* Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.

* 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.

* For studies where data management activities are conducted within Takeda, leads and manages clinical trial data collection set-up, data review, and database lock: (a) Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO and eCOA. (b) 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, database lock plans. (c) Leads data review, including query management, and leads activities required for interim and final database locks. (d) May oversee above activities at the program level.

* Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.

* Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.

* 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.

* Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.

* Acts as a process expert for operational and oversight models.

* Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.

* May prepare metrics to support the function’s KPIs.

* 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.

* Contributes or Leads functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with company, departmental or functional requirements.

* Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables

* Champions and adopts technology improvements and tools for use in clinical data management processes.

* Ensure compliance with own Learning Curricula, corporate and/or GXP requirements. * Performs other duties as assigned. Educational Qualifications

* BS/BA required preferably in a health-related, life science area or technology-related fields.

Experience

* Preferred 6-8 years or equivalence experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.

* 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 in one or more therapeutic areas preferred.

* Ability to handle multiple development programs simultaneously.

* NDA/CTD Experience preferred.

* Strong knowledge of data management best practices & technologies as applied to clinical trials.

* Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

* Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.

* Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.

Special Skills/Abilities

* Advanced knowledge of office software (Microsoft Office).

* Experience with budget planning & management.

* Strong knowledge of relational databases and experience using multiple clinical data management systems.

* Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.

* Ensures adherence to functional budget, and provides timely updates to manager regarding additional, potential spend or cost savings.

* Expert knowledge of CDISC standards, SDTM preferred. Good experience leading standards selection and implementing in clinical trials is ideal.

* Expert knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes. Behavioral Competencies

* Pragmatic and willing to drive and support change.

* Is comfortable with ambiguity.

* 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.

* Embody a culture of continual improvement and innovation; promote knowledge sharing.

* Demonstrated strong matrix leadership and communication skills.