Job Description:

Translations Project Manager I

Job Location

US-PA-Pittsburgh | US-PA-Philadelphia | US-MA-Medford | US-OH-Cleveland

Overview

ERT is looking for a Clinical Systems Translations Project Manager to be responsible for project managing the translations development of electronic solutions for all languages in assigned studies. The Translations Project Manager is client-facing and establishes and maintains scope, provides recommendations, oversees the translations project budget, as well as manages the translations providers supporting the study.

Responsibilities

1. Work directly with the client to schedule and scope translations projects, and drive completion
of translations-related milestones per the schedule. Identifies risk and develops mitigation
strategies related to translation deliverables.
2. Work as a client-facing project team member responsible for providing translations
recommendations as well as project plans for the client, and for also presenting capabilities
and issue resolution. Helps advise the client on how best to achieve EC/IRB submissions by
balancing ICH GCP Guidance with software development timelines.
3. Responsible for budget management for spend that may exceed $1M per assigned study,
ensuring vendor spend does not exceed budget, and escalates accordingly if scope change
occurs. Manages PO approvals and invoice reconciliation for assigned studies.
4. Liaise with General Counsel to vet ad approve of copyright agreements oftentimes required
to support studies.
5. Utilize the technical process required to implement translations into devices, and use technical
troubleshooting skills.
6. Coordinate with translations vendors to deliver work per schedule requirements and defined
scope; this includes initiating new projects with the vendor, and tracking status and progress
of all assigned projects and holding the vendor accountable for CAPAs should quality issues
occur.
7. Review the work product of the translation agency for completeness and escalate and mitigate
quality of delivery issues.
8. Support the sales team with pre-award presentations to educate clients regarding translations
methodologies based upon regulatory authority submissions strategy and endpoint.
9. Works closely with the cross-functional team to ensure hand-offs are completed on-time and
with quality, communicates risk and solutions to the team proactively if issues occur. Manage
the life cycle of translations-issues from identification through to preventative action.

OTHER DUTIES AND RESPONSIBILITIES:
1. Use and troubleshoot internal tools to implement translations
2. Support Quality Control & Assurance/Validation by fixing defects related to translations
during the software testing process.
3. Represent the Clinical Systems Translations department in client meetings.
4. Educate other functional areas and translations vendors on the translations process.
5. Evaluate translations processes for continuous improvement, and participate on crossfunctional teams to drive improvement initiatives.
6. Other duties as assigned by management

The duties and responsibilities listed in this job description represent the major responsibilities of
the position. Other duties and responsibilities may be assigned, as required. ERT reserves the
right to amend or change this job description to meet the needs of ERT. This job description and
any attachments do not constitute or represent a contract.

#LI-LM1

Qualifications

* Strong proofreading and attention to detail is required
* Comfortable using new technology, corporate software, and MSOffice
* Ability to troubleshoot software applications
* HTML experience
* Ability to troubleshoot software applications
Education:
* Bachelor's degree

Experience:
* Minimum 3-4 years Project Coordination/Project Management experience
* Proven track record for adhering to timelines and being a productive cross-functional team
member
* Familiarity with working in highly-regulated environments is preferred, and working in a
Life Science and/or Translations-related industry is a plus.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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