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Summary:

This is a senior-level role reporting directly to the Clinical Document Team Manager (CDTM). The Clinical Document Lead (CDL) is responsible for the high-level QC of the eTMF and for all work completed by the Clinical Document Specialist (CDS) Team. As a senior employee, the CDL is involved in helping to mentor and train new employees with direction from the CDTM. The CDL is also r sponsible for reporting on deadlines to the Project Manager and Client when needed. When the CDTM is not available, the CDL is responsible for interacting with the internal team and other departments.

Responsibilities:

Responsible for review of study documentation for Trial Master File (TMF) quality for sponsor and/or CROstudiesProactive in researching eTMF or available resources to find answers to the queries at indexing and reviewstage, before they are escalated to PM/clientConduct retraining for team members as required on an ongoing basis keeping PMs and Senior TMF QualitySpecialist in loop.Conducting trainings for new hires in collaboration with CDTMEnsure smooth functioning of assigned projects from start to endManages Q&As for assigned projectsCoordinate with PMs for requirements of updates in system configurations or mapping documentsAssist the PMs in client meetings or provide them with required data on assigned projects as needed by theclientsAssist Senior TMF Quality Specialist in performing internal audits when neededReview audit plans before finalizing with the client and ensure the internal audits are performed as per theaudit planSuggest improvement to the processes and performances of fellow team membersMentor fellow team members as requiredCoordinate with global team members to ensure the consistency in assigned projectsAssist with User Acceptance Testing during product development and releaseWork with cross functional teams including Project Management, Business Development, Client Services,Development, and IT on the implementation and management of client projectsGather and provide feedback on features and enhancements that may be needed on an ongoing basis toDevelopment TeamServe as part as the Project Team on client projectsBecome an expert in the TMF Reference Model and stay current on regulatory changesBecome an expert in Trial Interactive features and functionality and work with the Director of Clinical Operations,Project Management, and Development to recommend new features and functionalities to improve theproduct and reduce manual activitiesRespond to client requests for new project initiatives; collaborate with various members of the Productionand Sales teams to assess the scope of work and produce cost estimatesTake a proactive role in learning about clients’ industry, business needs, and company culture, educating theProject Team, identifying new business opportunities, and providing a high level of serviceLine manage individual employees or groups, as requiredSet and fulfill client expectationsPerform other special projects or duties when requiredComplete all other tasks that are deemed appropriate for your role and assigned by your manager/ supervisor

About You:

Knowledge of clinical development phases and processes, including GCP and ICH regulationsExpert in TMF filing best practices, clinical documentation at all levelsSuperior written and spoken communication skills in EnglishProficiency in Microsoft Office (Word, Excel, Outlook), and knowledge of eClinical technologiesProficiency in Document Management (Adobe professional, knowledge of Scanning, indexing, using ISI Toolsand Capture Perfect)Support supervisor in people management and administrative task.Minimum bachelor’s degree or its equivalentMinimum 5 years of experience in the Life Sciences industryExperience with essential documents and other study documentationHands-on experience project management practices and priority settingProficient in client interaction and deliverables

A plus if you have...

Previous employment in Pharmaceutical, CRO, Medical Device, or Investigative Site or eTMFExperience in a leadership role, mentoring, training, performance evaluations, etc.Minimum 6 months of experience of supporting line managementAbility to multitask in a fast-paced environmentWork well with people from a variety of different backgrounds and culturesBuild relationships with clients and co-workersCan work independently and as part of a teamTake proactive measures to solve problems and commit to a high level of serviceAble to manage team building, coordination, and utilizing the skillsSkilled in performing quality assessment and designing corrective actionsExcellent project management and client interactionExpertise in handling escalations from internal and external clientsProficient in receiving feedback and escalations as an opportunity to improve

TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.