COA License and Translation Associate Manager

Thermo Fisher Scientific • Philadelphia, PA

10d • $75 - $85 • Remote

About The Position

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 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.

Requirements

• Bachelor’s 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.
• 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
• 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.
• 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.

Responsibilities

• 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 team’s 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 organization's project teams to resolve issues.
• Support the management of the organization's COA/eCOA licensing database and related trackers.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level