AD Clinical Trial Tools and Technologies, Non-standard Clinical Data Acquisition & Delivery

Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 8, 2022

Job Description:

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 DescriptionACCOUNTABILITIESAs the Associate Director, Clinical Trial Tools and Technology, you will create and implement standard processes governing end to end data delivery integration activities for EDC, eCOA, PK, LAB, BIOMARKER and IMAGING data. You will report to the Sr. Director, Clinical Trial Tools and Technology.

• You will oversee creation of training associated with integration activities for EDC, eCOA, PK, LAB, BIOMARKER and IMAGING data.
• You will be responsible for identifying gaps and possible improvements to all clinical data cleaning tools and processes to ensure audit readiness and adherence to GCP guidelines. Ensure systems are fit for purpose and ensure all validation activities are thorough, documented and fit for purpose.
• Secure agreements with appropriate stakeholders (including but not limited to Clinical Operations, Clinical Supplies, IT, and Quality organizations) to develop technology strategies across Clinical Studies in alignment with established Takeda SOPs & Policies, and governance models.
• Manage team of employees and contractors in support of systems and data integration
  CORE ELEMENTS RELATED TO THIS ROLE
  • Accountable for system delivery life cycle, including deployment strategies, user training and management.
  • Act as a primary business change agent to ensure adoption of new capabilities and business process
  • Serve as the first point of contact for Clinical Technology vendors when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality.
  • Act as a process expert for operational and oversight models.
  • Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents.
  • Participate in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.
  • Set strategy for study level technology & deployment and defines vendor oversight activities. .Leadership
    • Manage small team of employees and contractors in support of systems and data integration
    • Demonstrated Business Relations Management experience with multiple vendors, setting strategy and implementation for multiple clinical technologies including but not limited to: electronic Clinical Outcome Assessment (eCOA), electronic Patient Reported Outcome (ePRO), Medical Devices, Interactive Voice/Web Response System (IRT), Electronic Data Capture (EDC), and Clinical Data Wearhouse.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
      • BS/BA required or MS preferred in a health-related, life science area or technology-related fields.
      • Minimum of 10 years' drug development experience
      • Experience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes
      • Experience with FDA and ICH regulations and industry standards and quality control principles.
      • Project management skills and experience managing implementation of eCOA, IRT, EDC, Clinical Data Wearhouse or CTMS for large drug development programs
      • Experience applying System Development Life Cycle (SDLC) and developing strategies to address required changes to clinical trial technologies due to evolving GXP regulations
      • Business Relations Management experience with multiple vendors, setting strategy and implementation for multiple clinical technologies: electronic Clinical Outcome Assessment (eCOA), electronic Patient Reported Outcome (ePRO), Interactive Voice/Web Response System (IRT), Electronic Data Capture (EDC), Clinical Data WearhouseBase Salary Range: $ 140,000 to $190,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement 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.Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.EEO StatementTakeda 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Cherry Hill , AD Clinical Trial Tools and Technologies, Non-standard Clinical Data Acquisition & Delivery, Healthcare , Cherry Hill, New Jersey