Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

The Associate eCOA Licensing & Translations Manager provides support to the Digital project team around the licensing and translation of clinical outcomes assessments (including validated COA/eCOA instruments).

Job Description:

• Work with cross-functional teams to document requirements, obtain necessary licenses, and translation agreements related to clinical outcomes assessments (COAs/eCOAs)
• Support RFPs, quotation analysis, and act as the internal point of contact for the licensing and translation / linguistic validation process related to clinical outcomes assessments (COAs/eCOAs)
• Maintain relationships with instrument authors and copyright holders and determine electronic implementation requirements.
• Copyright/license management - prepare, update and implement appropriate forms of contract and commitment with copyright holders.
• Oversee the execution of licenses and translation agreements upon the direction of the DIM
• Coordinate the translation / linguistic validation processes with translation agencies including, processes, discussions on eCOA design, system functionalities, project timelines and screenshots reviews & author approval processes
• Support project teams' key milestone achievements on decentralized and digitally enabled trials while managing issues and obstacles related to instrument translation and licensing.
• Collaborates with key collaborators and PPD project teams to resolve issues.
• Support the management of the PPD's COA/eCOA licensing database and related trackers

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Knowledge, Skills and Abilities:

• Working knowledge of the instrument licensing process and industry challenges
• Understanding of the linguistic validation process and the impact of migrating a paper instrument to electronic (eCOA) format has on that process
• Ability to coordinate tasks and teams.
• Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
• Possesses cross cultural awareness and is able to adapt appropriately.
• Has an understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology.
• Basic knowledge of Project Management.
• Ability to handle external vendors according to project scope, budget, timelines and quality standards.
• Displays effective communication skills (listening, oral, written) and can communicate in English language (oral, written).
• Sound social skills, is flexible and adapts to changing situations.
• Is organized, proficient at multi-tasking with good attention to detail.

Thermo Fisher Scientific values the health and well-being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform under stress while prioritizing and balancing multiple activities.
• May require minimal as needed travel. (Recruiter will provide more details.)

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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