Data Reporting and Cost Containment Corporation (DRCC)

Data Reporting and Cost Containment Corporation provides consulting, auditing and data reporting services that partners with health systems and payor clients. We provide our clients with the tools, services and advice they need to thrive in the current complex and uncertain pluralistic payment environment and achieve visionary, organizationally relevant results.

 DRCC has expertise in all aspects of population health, strategy, delivery system development, payment systems reform, workforce development and population health management support services, including peerless analytics and performance improvement. Permanent, contract/temporary consultants, coders, and medical record reviewers, DRCC helps the healthcare industry find exceptional talent professionals for any business working in the areas of population health, HEDIS, and HCC Risk Adjustment Coding.

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Senior Manager, Clinical Data Management Boston, Massachusetts, Remote

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Job DescriptionObjective / Purpose:The Senior Manager Clinical Data Management is responsible for timely and high-quality data management deliverables supporting the Takeda portfolio. They are responsible for conducting oversight of Data Management activities at the project or program 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.The Senior Manager Clinical Data Management provides and enables solutions for complex problem solving that align with the Takeda 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) CDM Staff. They will lead cross-functional team members to perform proper Data Reviews and provide guidance on CDISC standards.Accountabilities:<ul><li>Responsible for leading data management activities for in-house and outsourced studies; may manage staff responsible for performing those activities.</li><li>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.</li><li>Contributes influential leadership in collaboration with other Takeda Stakeholders to ensure established milestones and deliverables are met with the highest degree of quality.</li><li>Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks.</li><li>Provides input to functional governance with Takeda’s strategic suppliers. Partners with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams.</li><li>For studies where data management activities are conducted within Takeda, leads and manages clinical trial data collection set-up, data review, and database lock.</li><li>Works with other functions to complete 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. May oversee above activities at the program level.</li><li>Participates in preparing function for submission readiness and may represent function in a formal inspection or audit.</li><li>Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.</li><li>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.</li><li>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.</li><li>Acts as a process expert for operational and oversight models.</li><li>Maintains SOPs, process maps and templates and timelines to support functions operational and oversight models.</li><li>May prepare metrics to support the function’s KPIs.</li><li>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.</li><li>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.</li><li>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.</li><li>Champions and adopts technology improvements and tools for use in clinical data management processes.</li><li>Ensure compliance with own Learning Curricula, corporate and/or GXP requirements.</li><li>Performs other duties as assigned.</li></ul>Education & Competencies (Technical and Behavioral):<ul><li>BS/BA required preferably in a health-related, life science area or technology-related fields.</li><li>Preferred 6 plus years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.</li><li>Proven track record of strong project management skills and experience managing data management activities for large drug development programs.</li><li>Experience with all phases of development in one or more therapeutic areas preferred.</li><li>Ability to handle multiple development programs simultaneously.</li><li>NDA/CTD Experience preferred.</li><li>Strong knowledge of data management best practices & technologies as applied to clinical trials.</li><li>Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.</li><li>Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.</li><li>Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.</li></ul>Location: Massachusetts - VirtualWorker Type: EmployeeWorker Sub-Type: RegularTime Type: Full timeJob Exempt: Yes#LI-Remote
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Takeda

Senior Manager, Clinical Data Management Boston, Massachusetts, Remote

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