Manage the overall screenshot development and proofing process, communicating issues to Development 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 seasoned experience for own projects and direct reports for risk mitigation planning for study work/escalation prevention.
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/facilitates training based on subject/need.
Responsible for onboarding & training of new hires, managing onboarding and assimilations activities, assessing effectiveness at 90 days post hire and developing a plan for key areas of focus.
Assists sales teams and reviews proposals as requested for translations, linguistic validation, and licensing procurement projects.
BD initiatives (includes bid defenses), consultative with customers.
Coaches the team in providing superior customer support, manages vendors closely, in overseeing their project deliveries with accountability, and keeps up with industry standards as it relates to translations methodologies for clinical trials and medical devices and also copyright licensing.
Develops strategic alliance, preferred vendor relationships, and operational efficiencies with select copyright holders.
Translation Vendor Management: manages project deliverables & timelines on a per project basis.
Translations Vendor Management: facilitates monthly check in, quarterly KPI conversations, CAPA review, Project Check Ins, Personnel Checks, Process Improvement.
Responsible for the implementation of continuous improvement initiatives - cost follow ups, process, document templates, etc.
Influences strategic decision mkg; execution in support of strategic initiatives.
Develops & leads execution for continuous improvement initiatives geared toward improving translation quality, process efficiency, harmonization across products, and cost reduction through tools and process enhancements that are scalable to various volume requirements.
Ensures practices (internal & external) and procedures meet the regulatory compliance standards for Good Clinical Practices.
Exemplifies and leads the departments global communication standards with internal resources.
Manages and oversees development of translations procedures as well as training rollout.
Provides and participates in client and vendor audits as departmental SME.
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.
First point of contact to resolve complex process oriented client-escalations.
Provides Translations expertise & program/account level support for key customers in creating and supporting new procedural rollouts, training, and education on the overall Clario translations lifecycle as well as general translations knowledge, process improvement initiatives, advising on best practices, escalation support, and process harmonization efforts.
Fully manages translation study budgets, escalating issues to finance and management as appropriate.
Able to identify and solve financial/issue management at the process level.
Assists in completion and investigation of CAPA's both internal and external.
Participates in Operational readiness planning and related task ownership.
Responsible for Study assignment activities.
SME for all service lines supported by the Translations Department.
Supports leadership and team-building activities.
Develops strategies to promote customer service & initiate process dev't for NPIs.
Manages assigned Translations and Instrument Support teams (LP), and for quality and timely delivery of project deliverables related to these functions (as needed).
Responsible & accountable for development of best practices, training compliance, and capacity management of assigned resources.
Responsible for assigned key client, copyright holder and author relationships, supports Sales in new product requests.
Develops training and provides guidance on Translations related procedures (within Dept.).
Develops and presents Training regarding CSTL process to various departments outside of Translations.
Provides instrument and library support & development, providing deliverables.
Project Manages License Procurement Activities, Rater Training, and any other specialized offerings.