Associate Director, Clinical Data Management Compliance and Quality Innovations

Company: Takeda Pharmaceutical
Location: Boston
Posted on: August 7, 2022

Job Description:

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Job Description

Associate Director, Clinical Data Management Compliance & Quality Innovations - REMOTE

Takeda

Takeda fosters a collaborative and stimulating work environment, filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.

As one of the world s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; gastroenterology, oncology, neuroscience, plasma-derived therapies, rare diseases and vaccines. Boston (Massachusetts) is the R&D headquarters.

Associate Director, Clinical Data Management Compliance & Quality Innovations

As the Associate Director, Clinical Data Management Compliance & Quality Innovations you will be accountable for overseeing and ensuring proper execution of prioritized Clinical Data Management (CDM) or cross-functional processes related to timely delivery of quality study Databases (e.g., Quality Gates, Data Review Process). You will report to the Director, Data Management Operations.

You will partner with the Director of DM Operations, the CDM Leadership Team and other cross-functional Leaders to identify and prioritize critical processes requiring oversight to confirm timely execution, appropriate cross- functional engagement, adequate reporting of process Compliance & Quality Index level findings to CDM LT, CDM Leads and other study-level and functional stakeholders.

You will perform continuous evaluation of DM processes and tools to drive optimization & alignment with R&D ecosystem including, but not limited to, TAU-specific data Standards deployment, application (adoption), provide Technical Data Management perspective across CDM & R&D on relevant quality Dashboards, collect and share best practices for Data quality.

Key Accountabilities

• Lead data management process oversight and ensuring proper execution of prioritized Clinical Data Management (CDM) or cross-functional processes related to timely delivery of quality study Databases (e.g., Quality Gates, Data Review Process), and/or managing staff responsible for performing those activities.
  • Perform routine evaluation of processes to determine adherence to procedural documentation, active process engagement by study team functional representatives, and adherence to study milestone cycle times
  • Manage TAU-specific data Standards deployment, application (adoption), and fit for purpose from a Clinical Data Management perspective
  • Develop KPIs, metrics and quality dashboards to track process quality, efficiency and compliance
  • Engage with CDM Study Leads to provide feedback on study team performance on evaluated processes
  • Recruit and manage a team of Compliance & Quality Innovation specialists, and coordinate deployment to various TAUs or Study teams based on portfolio priorities
  • Act as a process expert for operational and oversight models.
  • Maintain SOPs, process maps and templates and timelines to support functions operational and oversight models.
  • Prepare metrics to support the function s KPIs.
  • Represent function in external professional initiatives and organizations such as SCDM, DIA, etc. to identify industry best practice and increase the visibility of Takeda.
  • Define and Lead 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.
  • Work to ensure the quality of the data in each database and on time delivery, as well as 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/or GXP requirements.
    Educational Qualifications
    • BS/BA in a health-related, life science, quality assurance or instructional design areas or technology-related field preferred or equivalent combination of education, training and experience
      Experience
      • Minimum 8 years' experience in clinical data management, compliance, or quality management.
      • Minimum of 3 years of line management experience or equivalent.
      • Project management experience managing data management coding activities for large drug development programs.
      • Experience with GCP, regulatory and ICH guidelines as applicable to clinical data management; clinical experience in one or more of the following therapeutic areas desired: cell therapy, oncology, GI, Neuroscience, PDT, Rare disease, Vaccines and/or vaccine.
      • Experience managing multiple development programs simultaneously.
      • NDA/CTD Experience preferred.
      • Experience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
      • Experience with broad drug development process with expertise in the cross-functional interfaces with the data management function.
      • Experience with FDA and ICH regulations and industry standards applicable to data capture and data management process.
        Special Skills/Abilities
        • Advanced knowledge of office software (Microsoft Office).
        • Strong knowledge of relational databases and experience using multiple clinical data management systems.
        • Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials.
        • Experience developing internal data standards is ideal.
        • Advanced knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes..
          Job Complexity/Travel:
          
          High complexity at program that include multiple projects and/or platforms.
          
          Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be required.
          
          Supervision
          
          Minimal supervision required, should be able to function independently and collaboratively with all levels of employees.
          
          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
            Location: Cambridge, MA or 100% Virtual
            
            Base Salary Range: $160,000-190,000 based on candidate professional experience level. Employee 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, Company Holidays, Personal & Vacation Days, Student Loan Repayment Program and Paid Volunteer Time Off.
            
            This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. 8-5-101 et seq
            
            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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