As part of the Clinical Trials Tools & Technologies organization, this role is accountable for the following activities:
Manage standard processes governing end-to-end data delivery integration activities for EDC, eCOA, PK, LAB, BIOMARKER, and IMAGING data.
Create Data Transfer Agreement (DTA) or Transfer Specification for 3rd party vendors in support of Clinical Trial.
Perform training associated with integration activities for EDC, eCOA, PK, LAB, BIOMARKER, and IMAGING data.
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.
Secures 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.
CORE ELEMENTS RELATED TO THIS ROLE
Is accountable for system delivery life cycle, including deployment strategies, user training and management.
Acts as a primary business change agent to ensure adoption of new capabilities and business process
Serves 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.
Leads study level technology & vendor oversight activities.
Acts as a process expert for operational and oversight models.
Confirms archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents.
Participates in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.
Follow designated strategy for study level technology & deployment and defines vendor oversight activities.
Performs other duties as assigned.
CORE ELEMENTS RELATED TO THIS ROLE
The person in this role should have the following experience:
Project management skills and experience managing implementation of integrations or implementation of clinical technologies like eCOA, IRT, EDC, Medical Devices, and Clinical Data Wearhouse for large drug development programs.
Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.
Solid experience applying System Development Life Cycle (SDLC) and developing strategies to address required changes to clinical trial technologies due to evolving GXP regulations.
Experience with all phases of drug development.
Moderate supervision required, should be able to function collaboratively (with some guidance) with all levels of employees
Decision-making and Autonomy
May lead study level negotiation and agreement for data transfer or integration on behalf of Takeda.
Participate on complex, cross-organization technology and business process projects.
Drive project delivery in complex matrix organization
Ability to identify new innovative trends in technology to better support clinical trials
Support implementation of innovative solution in Takeda
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.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
BS/BA required or MS preferred in a health-related, life science area or technology-related fields.
Minimum of 6 years drug development experience.
Base Salary Range: $102,200 to $146,000 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 position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
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.LocationsUSA - MA - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time