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ERT Translations Project Manager I in Pittsburgh, Pennsylvania

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.

  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.

  1. 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.

  1. 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.

  1. Liaise with General Counsel to vet ad approve of copyright agreements oftentimes required

to support studies.

  1. Utilize the technical process required to implement translations into devices, and use technical

troubleshooting skills.

  1. 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.

  1. Review the work product of the translation agency for completeness and escalate and mitigate

quality of delivery issues.

  1. Support the sales team with pre-award presentations to educate clients regarding translations

methodologies based upon regulatory authority submissions strategy and endpoint.

  1. 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.

  1. Represent the Clinical Systems Translations department in client meetings.

  2. Educate other functional areas and translations vendors on the translations process.

  3. Evaluate translations processes for continuous improvement, and participate on crossfunctional teams to drive improvement initiatives.

  4. 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.

● 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.

Hours: Full Time

External Company Name: eResearch Technology

External Company URL: www.ert.com

Street: 225 West Station Square Drive, PA

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