Bioclinica
Location
Bangalore | India
Job description
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 s, 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 CAPAs 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 were 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.
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