translation / localization project manager | budapest

posted
contact
randstad hungary
job type
permanent
apply now

job details

posted
location
budapest
job category
Pharma / Healthcare
job type
permanent
reference number
29572 / 30877
contact
randstad hungary
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Cégleírás / Organisation/Department

Join our brand new team in Hungary and be a part of this outstanding opportunity. Clario has a US headquarters with 30 facilities in nine countries. If you would like to work in a full remote setup and you would like to make an impact in the clinical trial industry, then this one-of-a-kind company is for you!

Clario. The Best of ERT & Bioclinica! Two industry-leading companies merged together to generate the richest clinical evidence.  

Clario delivers the leading endpoint technology solutions for clinical trials. Through experience gained from over 19,000 clinical trials delivered in support of 870 regulatory approvals, Clario fuses scientific expertise and global scale into the broadest endpoint technology platform to enable pharmaceutical, biotech, and medical device partners to transform lives. Through Trial Anywhere™, Clario has mastered the ability to generate rich evidence across all trial models: decentralized, hybrid, and site-based clinical trials. With 30 facilities in nine countries across North America, Europe, and the Asia Pacific, Clario’s global team of science, technology, and operational experts has been delivering the richest clinical evidence for nearly 50 years.

Pozíció leírása / Job description

Join us as a Clinical Systems Translations Project Manager and take responsibility 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.

As a Translations Project Manager, you will

  • Work directly with Clario’s clients to schedule and scope translations projects, and drive completion of translation-related milestones per the schedule. Identifies risk and develops mitigation strategies related to translation deliverables.
  • 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. Help advise the client on how best to achieve EC/IRB submissions by balancing ICH GCP Guidance with software development timelines.
  • Take responsibility for budget management for spending that may exceed $1M per the 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.
  • Liaise with General Counsel to vet and approve copyright agreements oftentimes required to support studies.
  • Utilize the technical process required to implement translations into devices, and use technical troubleshooting skills.
  • 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
  • Review the work product of the translation agency for completeness and escalate and mitigate quality of delivery issues.
  • Support the sales team with pre-award presentations to educate clients regarding translations methodologies based upon regulatory authority submissions strategy and endpoint.
  • Work closely with the cross-functional team to ensure hand-offs are completed on time and with quality, communicate risk and solutions to the team proactively if issues occur. Manage the life cycle of translations-issues from identification through to preventative action.
  • Collaborate with other teams on translation-related matters, and educate stakeholders/vendors on the translations process.
  • Evaluate translations processes for continuous improvement, and participate in cross-functional teams to drive improvement initiatives.

Elvárások / Requirements

What do we seek?

  • Bachelor’s degree
  • Minimum 3-4 years Project Coordination/Project Management experience
  • Strong proofreading and attention to detail is required
  • Comfortable using new technology, corporate software, and MS Office
  • Ability to troubleshoot software applications, with HTML experience
  • Proven track record for adhering to timelines and being a productive cross-functional team member
  • Comfortable working in highly-regulated environments is preferred, and experience working in a Life Science and/or Translations-related industry is a plus.

Amit kínálunk / Offer

What we can offer:

  • Multicultural environment
  • Global impact 
  • Support your professional development through internal and external training and certification programs
  • Home office - working remotely
  • Excellent On-Boarding plan
  • Global Exchange Program
  • Exceptional Tuition Reimbursement scheme
  • Comprehensive Benefits Package

Kapcsolattartó / Information

Apply now and we will reach out to you as soon as possible. If you are interested in the role for more information, please contact us:

Tünde Sztojov (tunde.sztojov@randstad.hu) OR Timea Gál (timea.gal@randstad.hu)