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Healthcare Information Services Director

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Takeda PharmaceuticalNew Freedom, PA
  • By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.
  • I further attest that all information I submit in my employment application is true to the best of my knowledge.
  • Job Description REMOTE OPPORTUNITY OBJECTIVE : As the Associate Director, Clinical Data Management you will report to the Director, Clinical Data Solutions and you will ensure the quality for all Data Management (DM) deliverables globally within a therapeutic area.
  • You will provide oversight of DM budget in collaboration with program management.
  • You will provide data management expertise and capability to support global development programs and post-marketing registration and non-registration studies.
  • Contribute to management of strategic vendor partnerships to maximize effectiveness of external (CRO) resources.
  • ACCOUNTABILITIES: Manage vendor oversight activities across all global development programs within a therapeutic area.
  • Represent data management function on the Clinical Sub-team ensuring aligned expectations between the CRO and Takeda for all data related deliverables, especially to support essential decisions and regulatory submissions.
  • Provide input to functional governance with Takeda's strategic suppliers.
  • Partner with appropriate team members to resolves issues escalated from the vendor.
  • Represent function in external professional projects and organizations such as SCDM, CDISC, DIA to identify industry best practice and increase the visibility of Takeda.
  • Required EDUCATION, EXPERIENCE, LICENSES/CERTIFICATIONS: Minimum 8 years' data management and/or drug development process with expertise in the cross-functional interfaces with the data management function.
  • Experience managing vendor relationships and alliance partnerships with at least 4 years' experience in this area.
  • Minimum 3 years' of line management experience or equivalent Project management experience 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.
  • Expert knowledge of data management best practices, standards library development and maintenance.
  • Understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
  • Knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function.
  • Knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
  • 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.
  • Locations California - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time

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