JOB DESCRIPTION
PPD, a part of Thermo Fisher Scientific, is a leading global contract research organization focused on delivering life-changing therapies. Our mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
About the Department:
Now, more than ever, it’s critical to have a strategy to implement decentralized trials in order to continue to advance and protect life-saving clinical research. PPD is pioneering digital capabilities and deploying solutions to streamline protocols, putting patient experience at the center of every design.
About the Position:
The Associate eCOA Licensing & Translations Manager provides support to the Digital project team around the licensing and translation of clinical outcomes assessments (including paper and electronic administration).
Job Description:
- Work with cross-functional teams to document requirements, obtain necessary license agreements/guidance from copyright holders and distributors and translation agreements related to clinical outcomes assessments (COAs/eCOAs)
- Support RFPs, quotation analysis, and function as the internal point of contact for the licensing and translation / linguistic validation process related to clinical outcomes assessments (COAs/eCOAs)
- Build and maintain relationships with instrument authors, copyright holders and distributors.
- Work with copyright holders to understand any translation or electronic implementation requirements.
- Copyright/license management- coordinate, prepare, update and implement appropriate forms of contract and commitment with copyright holders.
- Oversee the execution of licenses and translation agreements between Sponsors and copyright holders
- Coordinate the translation / linguistic validation processes with translation agencies including, processes, project timelines and screenshots reviews author approval process (as applicable for electronic implementation).
- Support project teams’ key milestone achievements on decentralized and digitally enabled trials while managing issues and obstacles related to COA translation and licensing.
- Collaborates with key stakeholders and PPD project teams to resolve issues.
- Support the management of PPD’s COA/eCOA licensing database and related trackers
*LI-Remote
*LI-NA1
Job Qualification
Education and Experience:
- Bachelor’s degree or equivalent and relevant formal academic / vocational qualification
- Previous eCOA/licensing experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’ experience) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
- Working knowledge of the COA licensing process and industry challenges
- Working knowledge of the linguistic validation process and the impact of migrating a paper instrument to electronic (eCOA) format has on the 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 adapts 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 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).
- Sound interpersonal skills, flexibility.
- Is organized, proficient at multi-tasking with good attention to detail.
PPD 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 successfully under pressure while prioritizing and handling multiple projects or activities.
- May require minimal as-needed travel (0-10%)
The annual salary range estimated for this position is $70,000 – $85,000. This position will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Actual compensation will be confirmed in writing at the time of offer.
We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally includes:
- A choice of national medical and dental plans, and a national vision plan
- A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HRAs) or Health Savings Account (HSA)
- Tax-advantaged savings and spending accounts and commuter benefits
- Employee assistance program
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer time off in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan