Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Sr. Manager, Clinical Biomarker Data Strategy and Logistics in our Cambridge office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliverBetter Health and a Brighter Futureto people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
- Build and maintain processes to support Takeda s clinical biomarker data organization and integrity.
- Lead Clinical Biomarker Innovation & Development efforts in implementing and managing CDISC compliant biomarker data standards across all therapeutic areas.
- Effectively execute the Clinical Biomarker Innovation & Development Logistics group s clinical study start up process.
- Support Takeda s Translational Research strategy by ensuring successful collection and use of valuable clinical specimen assets.
- Form strategic partnerships across the global Takeda organization, including Clinical Data Technology & Standards, Clinical Data Management, Clinical Operations and Technical Services, in order to support Translational clinical biomarker data needs.
- Lead effort to implement biomarker data standards across all Takeda therapeutic areas.
- Represent Clinical Biomarker Innovation & Development in Takeda technology and data initiatives.
- Develop, implement and document standard operating procedures related to clinical biomarker data process flow.
- Work with data standards, data management, biostatistics and other key stakeholders to maintain and update existing biomarker data standards for oncology studies.
- Work with clinical teams to provide controlled terminology and mapping instructions for clinical biomarker data.
- Work with Translational Lead Scientists and Bioassay Scientists to develop data transfer specification documents that ensure complete and accurate delivery of clinical biomarker data.
- Interface with clinical project teams to mitigate issues with clinical biomarker data standards.
- Interface with vendors to mitigate issues with clinical biomarker data transfers and reporting.
- Govern established processes and SOPs related to clinical biomarker data processes.
- Lead effort to develop and implement training and educational material related to clinical biomarker data standards and processes.
- Support Clinical Biomarker Innovation & Development Logistics activities that have programming needs. Activities include clinical biomarker sample inventory data configuration for clinical biomarker sample management and sample reporting.
- Represent Clinical Biomarker Innovation & Development operational data needs by forming strategic partnerships with Global Standards Management, Clinical Data Integrity and Technology, Clinical Operations and other stakeholders across the global Takeda organization.
- Coordinate and drive completion of sample management plans for all clinical trials supported by Translational & Biomarker Research.
- Review key study start up documents such as clinical study protocols, requests for proposals for central laboratory services, budgets, contracts and laboratory manuals to verify that biomarker samples are collected as specified in the sample management plan.
- Responsible for creating effective biomarker sample collection language in model patient informed consent forms and for review of changes made during the IRB/EC approval process
- Work closely with key line functions such as Legal, Clinical Operations, Clinical Outsourcing and outside vendors to identify and provide solutions to issues regarding biomarker sample collection in clinical trials
- Responsible for consistency in biomarker sample collection language in documents supporting clinical trials; provide interpretation of the patient ICF language in support of Translational & Biomarker Research activities; maintain document compliance with controlled terminology
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS degree in information sciences, computer sciences, life sciences or related degree
- Experience in regulatory and/or quality data requirements
- An understanding of various biomarker assay platforms (NGS, IHC, Flow Cytometry, etc.) is highly desirable
- 5+ years experience in handling large clinical data sets
- 3+ years experience with clinical data standards
- Familiarity and experience with CDISC and related industry standards
- Microsoft Office proficiency, especially Word and Excel
- Programming skills (SAS, Python, other) a plus
- Highly organized, highly detail-oriented, able to excel in a matrix team environment, good written and verbal communication skills
- Requires approximately 10% or less travel.
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
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