Job Description

Are you seeking a purposeful and rewarding Project Management career opportunity?

Our eCOA Translations team is growing in India, and with big ambitions and a clear vision for the future, now is the time to join Clario as a Translations Project Manager.

These positions are subject to European and US working hour shift patterns, and are considered hybrid working roles from our offices in VG Heritage, 18/2, 18/3, Vani Vilas Road, Basavanagudi, Bangalore 560004.

What we offer:

Competitive compensation + shift allowances

Attractive benefits (security, flexibility, support and well-being)

Engaging employee programs

Technology for hybrid working and great onsite facilities

What you\'ll be doing:

The Clinical Systems Translations Project Manager is 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.

Assists with screenshot development and proofreading, troubleshoots errors and communicates to appropriate PM\xe2\x80\x99s, Development and SQE, conducts a quality control check on all internal and external deliverables.

Manages the overall screenshot development and proofing process, communicating issues to PDE and SQE team to ensure proper resolution and quality internal and external deliverables.

Project Ownership (Project Manages all tasks related to translations work for assigned study), managing both internal and external clients, copyright holders and vendors.

Manages all client facing meetings and emails, communicates directly with client, CRO and vendors regarding timelines, study requirements, and scope changes.

Provides direct support to Project Manager and Relationship Managers regarding translations timelines, complexities, author/copyright holder management, methodology requirement and the overall rollout of languages taking into account EC/IRB submission support, and SIV rollouts.

Sets-up projects directly with translations providers [Handoff English-US software files and screenshots, along with any applicable source files, to the translations vendor(s) to request costs and timeline estimates for work reflective of the scope of the study (indicating methodologies, etc.)

Provides SME advice to clients related to linguistic validation, and EC submission strategies.

Manages and troubleshoots technical issues related to all components that impacts translations build, testing and release with internal Clario teams. In addition, manages vendor training on technical files used to create software translations.

Assists with training of new team members, SME mentors/facilities training based on subject/need.

Translation Vendor Management: manages project deliverables & timelines on a per project basis.

Assists with continuous improvement initiatives - cost follow ups, process, document templates, etc.

Ensures practices (internal & external) and procedures meet the regulatory compliance standards for Good Clinical Practices.

Facilitates client-facing meetings: Manages overall client communication regarding all aspects of the CSTL cycle, helps support EC/IRB submission requirements, directs client on linguistic validation efforts, educates client on copyright holder requirements, helps manage and reduce client escalations regarding translations.

Fully Manages translation study budgets, escalating issues to finance and management as appropriate.

Assists in completion and investigation of CAPA\'s both internal and external.

Develops training and provides guidance on Translations related procedures (within Dept.).

Provides instrument and library support & development, providing deliverables.

Project Manages License Procurement Activities, Rater Training, and any other specialized offerings.

What we\'re looking for:

BA/BS in a related field.

2-3 years minimum of project management experience.

Strong proofreading and attention to detail is required.

Strong English language skills

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.

Familiarity with the software development industry.

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. We value the contribution each of our people brings. It\xe2\x80\x99s only through our people that we can continue to innovate technology that will shape the future of clinical trials. Courageously Curious

Our appetite to blend the best of domain expertise, technology and human understanding knows no bounds. We\xe2\x80\x99re relentless in pursuing the information, insights and inspiration that means we can continuously improve clinical trial site support services and technology solutions.

Behaviors:

We learn; embracing change, questioning how we work, finding a better way. And if it doesn\'t go to plan, we don\'t blame each other; instead, we own it and grow together
We partner\' with each other, with customers, patients and sites, working with them to understand their goals and then deliver the best solutions, Deliver Exceptional

We step forward because responsibility powers us; we don\xe2\x80\x99t leave others to do what we can do ourselves. We take charge of events, delivering exceptional work for our customers, patients and each other.

Behaviors:

We prioritize; focusing on what matters, never compromising on quality.
We commit; delivering what we say we will, working with energy and intent, sharing what we learn with each other., People first, always

We think of others before we think of ourselves. We have a deep understanding of our customers, and deep empathy for patients\xe2\x80\x94and each other. We\xe2\x80\x99re united by our purpose\xe2\x80\x94it\xe2\x80\x99s why we go above and beyond to support each other, emphatically.

Behaviors:

We do the right thing; for our customers, patients, sites and each other. And We\'re passionate about it.
We lift each other up; respectful of different views, we listen are inclusive, and support each other to succeed.

Clario