Translations Project Manager I

ERT

San José, CR

hace 2 días

Overview

Clario. The Best of ERT & Bioclinica!

In anticipation of our 2022 expansion plans, we're eager to share this opportunity and connect with you now.

Clario Costa Rica is looking for a Clinical Systems Translations Project Manager to 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.

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 Asia Pacific, Clario’s global team of science, technology and operational experts has been delivering the richest clinical evidence for nearly 50 years.

Responsibilities

As a Translations Project Manager, you will

Work directly with Clario’s clients 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.

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 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.

Liaise with General Counsel to vet ad approve of 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, communicates 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 translations related matters, and educate stakeholders / vendors on the translations process.

Evaluate translations processes for continuous improvement, and participate on cross functional teams to drive improvement initiatives.

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.

Clario reserves the right to amend or change this job description to meet the needs of Clario. This job description and any attachments do not constitute or represent a contract.

What 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.

Local to Costa Rica

Ability to work from home on a regular basis (this role will be fully remote to start, although we may offer hybrid options at a later date)

At Clario, we put people first, always. We are united and driven by patients, committed to making a difference, and we are always looking for the best talent to help us transform lives.

LI-DNI

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