COA License and Translation Associate Manager

Work Schedule

Environmental Conditions

Job Description

COA License and Translation Associate Manager

At Thermo Fisher Scientific youll 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 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.

PPD has an exciting opportunity in our Digital Trials group for a COA License and Translation Associate Manager to partner closely with cross-functional stakeholders to support the successful use of clinical outcome assessments (COAs/eCOAs) in clinical trials. This role is responsible for coordinating and documenting licensing translation and usage requirements for COA instruments ensuring all necessary permissions agreements and translations are secured in alignment with study timelines and regulatory expectations. Projects may be digital paper or a combination of administration.

The Associate Manager serves as a key point of contact between internal teams external vendors and instrument copyright holders facilitating clear communication and issue resolution. They oversee the end-to-end process for obtaining licenses and translation agreements maintain accurate records and documentation and provide guidance to project teams on COA-related compliance best practices and risk mitigation. Through proactive collaboration and attention to detail this role helps ensure COAs are implemented consistently compliantly and efficiently across global clinical studies.

• 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 determines electronic implementation requirements.
• Supports 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 Digital Implementation Manager.
• Coordinate the translation / linguistic validation processes with translation agencies including processes design system functionalities project timelines screenshots reviews and author approval processes.
• Support the project teams key milestone achievements on decentralized and digitally enabled trials while managing issues and obstacles related to instrument translation and licensing.
• Collaborate with key stakeholders and the organizations project teams to resolve issues.
• Support the management of the organizations COA/eCOA licensing database and related trackers.

Education and Experience:

• Bachelors degree or equivalent and relevant formal academic / vocational qualification
• Previous COA licensing experience that provides the knowledge skills and abilities to perform the job (comparable to 3 years).
• In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities:

• Working knowledge of the COA/instrument licensing process linguistic validation process and the impact of migrating a paper instrument to electronic (eCOA) format
• 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 can adapt appropriately
• Has an understanding and appreciation of clinical research/development including medical and therapeutic areas trial phases and medical terminology
• Basic knowledge of Project Management
• Ability to manage 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)
• Is organized proficient at multi-tasking with good attention to detail

At Thermo Fisher Scientific we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position which also includes the possibility of equivalent experience:

• 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 successfully under pressure while prioritizing and handling multiple projects or activities.
• May require as-needed travel (0-20%).

Location: Remote United States. Relocation assistance is NOT provided.
*Must be legally authorized to work in the United States without sponsorship.
*Must be able to pass a comprehensive background check which includes a drug screening.

The annual salary range estimated for this position is $75- $85K USD. This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy.