• Job Description

  Req#: TFSCGLOBALR01205609EXTERNALENGLOBAL

  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.
  

  Summarized Purpose:

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

  Essential Functions and Other Job Information:

  Essential Functions

  • Works with cross-functional teams to document requirements, obtain necessary licenses, and translation agreements related to clinical outcomes assessments (COAs/eCOAs).
  • Supports 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).
  • Maintains relationships with instrument authors and copyright holders and determines electronic implementation requirements.
  • Supports copyright/license management - prepares, updates and implements appropriate forms of contract and commitment with copyright holders.
  • Oversees the execution of licenses and translation agreements upon the direction of the Digital Implementation Manager.
  • Coordinates the translation / linguistic validation processes with translation agencies including, processes, discussions on eCOA design, system functionalities, project timelines and screenshots reviews & author approval processes.
  • Supports 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 stakeholders and the organization's project teams to resolve issues.
  • Supports the management of the organization's COA/eCOA licensing database and related trackers.

  Job Complexity

  Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
  Job Knowledge Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
  Supervision Received Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
  Exercises judgment within defined procedures and practices to determine appropriate action. Business Relationships Contacts are primarily internal to the company with infrequent external customer / vendor contact on routine matters.
  Builds productive internal / external working relationships.

  Qualifications:
  

  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). 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 instrument 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 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 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, is flexible and adapts to changing situations
  • Is organized, proficient at multi-tasking with good attention to detail

  Management Role: No management responsibility

  Working Conditions and Environment:

  • Work is performed in an office environment with exposure to electrical office equipment.
  • Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements:
  • Frequently stationary for 6-8 hours per day.
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Frequent mobility required.
  • Occasional crouching, stooping, bending and twisting of upper body and neck.
  • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
  • Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
  • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
  • Frequently interacts with others to obtain or relate information to diverse groups.
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
  • Ability to perform under stress.
  • Ability to multi-task.

  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

  Apply today! http://jobs.thermofisher.com

• About the company

  Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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