Manager, Clinical Outcome Assessment Operations (Remote)

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Job Description

Objectives:

The Manager, Clinical Outcome Assessment Operations will support the implementation and regulatory compliance of Clinical Outcome Assessments (COAs) in clinical studies.

Specific duties include:

• Facilitate COA selection and implementation by gathering and organizing information from GEO COA Leads and licensors/developers, ensuring correct COA identification, appropriate validation and COA availability.

• Collaborate with CROs and Takeda Regulatory teams to document and track regulatory and EC/IRB submission requirements for COA translations across different countries, ensuring compliance with evolving regulations and timely submissions.

• Support the linguistic validation process, review vendor contracts and deliverables, and verify the consistency of content across documents (COAs, training materials, etc.).

• Establish and maintain a comprehensive dashboard and repository for cataloging COA source documents, supporting materials and translations, enabling easy access, updates, and archival for current and future studies.

Accountabilities:

Manage COA Linguistic Validation Requirements and Support Study Start-Up:

• Coordinate the initiation of linguistic validation activities, ensuring necessary COA selections and pre-study translation documentation are completed.

• Evaluate and document COA translation needs for each study, including the availability of existing translations and the development of new translations or updates.

• Communicate with licensors and developers to gather information on COA validation, scoring, and language availability during early phases of study.

• Maintain ongoing communication to address updates and changes promptly with all stakeholders.

Monitor Regulatory Requirements and Changes:

• Work with CROs and regulatory teams to document and track COA submission requirements for different countries.

• Keep the dashboard updated with current COA requirements for each country.

• Stay informed about changes in COA submission requirements due to new regulations.

• Ensure all clinical studies comply with the latest regulatory standards.

Manage Vendor Contracts:

• Review vendor contracts to ensure all requested COAs and languages are included.

• Track vendor progress to ensure adherence to scope and timelines throughout the project lifetime. Ensure contracts align with project requirements and budget expectations.

• Work with DCT Licensing to ensure timely receipt of licensor-provided materials.

• Ensure compliance with licensing agreements and smooth transitions.

Assess and Verify Translation Deliverables:

• Review translation files from vendors to verify they meet the required methodology and format standards.

• Ensure accuracy and validation, including verification of certificates of translation.

• Distribute COA materials to various study team members as needed.

Catalog and Archive COA Translations:

• Develop and maintain a comprehensive dashboard and repository for all COA source documents and translations used in studies.

• Regularly update and archive translations to ensure they are accessible and compliant.

Core elements related to this role:

• Develops a network within the department; draws on network to answer questions and successfully execute responsibilities

• Demonstrates confidentiality in execution of all responsibilities.

• Strong communication, collaboration skills

Qualifications:

• Bachelor’s degree preferably in a health-related, life science area

• 5 years relevant work experience, or equivalent combination of training and experience

• Demonstrated successful experience in project/program management and matrix leadership

• Excellent organizational, planning, and written and verbal communication skills

• Excellent teamwork, organizational, interpersonal, and problem-solving skills

• Fluent business English (oral and written)

• Adaptable to a dynamic work environment and exhibits strong willingness to learn

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$108,500.00 - $170,500.00

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

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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