TransPerfect Looking for Clinical Document Team Manager at Pune Full Time

This is a senior-level manager role reporting directly to the Director of Clinical Operations of TransPerfect Life Sciences Solutions. The Clinical Team Manager (CTM) is responsible for the oversight of all Clinical Document Specialists (CDS I, CDS II, and CDS III), and most Clinical Document Leads. The CDTM is responsible for their department and is the main point of contact for the Director of Clinical Operations.DESCRIPTIONGlobal responsibility for the management of Clinical Operations focused on but not limited to eTMF support for CRO/Sponsor, as neededOversee Global Team involved with TMF management, paper, and eTMFManagement support for Medical Writing Team, SSU Team, and other areas within Clinical Operations as necessaryResponsible for resourcing and utilization across the Clinical Operations Teams, who report to the CTMPeriodic audits of client TMFs, when contracted, as well as internal TMF auditsWrite and edit SOPs to keep them current with process changes on TMF management, quality, and archivalWork on cross-functional teams including Project Management, Business Development, Client Services, Development, and IT on the implementation and management of client projectsAssist in RFI and RFP requestsServe as part of the Project Team on client projectsTrain team members as well as other TransPerfect Life Sciences Production Teams on essential documents and regulatory requirementsWork with TransPerfect Document Management to refine processes to meet Life Sciences requirementsParticipate and become 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 the product and reduce manual activitiesAssist with sponsor and regulatory auditsMonitor TMF resourcing to ensure an adequate level of staff as well as an adequate level of storage in relevant TransPerfect global locationsRespond to client requests for new project initiatives; collaborate with various members of the Production and 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 the Project Team, identifying new business opportunities, and providing a high level of serviceMonitor and communicate project progress, ensure strict adherence to deadlines and budgets, and ultimately produce high-quality deliverablesSet and fulfill client expectationsTravel up to 25% internationally as required for training of staff, client TMF audits, client meetings, and industry meetingsPerform other special projects or duties when requiredComplete all other tasks that are deemed appropriate for your role and assigned by your manager/supervisorREQUIRED SKILLSKnowledge of clinical development phases and processes, including GCP and ICH regulationsSuperior written and spoken communication skills in EnglishProficiency in Microsoft Office (Word, Excel, Outlook)Proficient with Windows Operating systems XP and higherExcellent in project management practices and priority settingREQUIRED EXPERIENCE AND QUALIFICATIONSMinimum bachelor’s degree or its equivalentMinimum 8 years of experience in the Life Sciences industryMinimum 2 years of experience of line managementExperience with Adobe applications, including Acrobat Professional, Reader, and DistillerSeasoned in client interaction and deliverables and addressing wide audienceDESIRED SKILLS AND EXPERIENCEAbility to multitask in a fast-paced environmentExperience in a leadership role, mentoring, training, performance evaluations etc. Work well with people froma variety of different backgrounds and culturesBuild relationships with clients and co-workersCan work independently and as part of a teamTake active measures to solve problems and commit to a high level of serviceHas a strong knowledge of technology within the industryExcellent people grooming skill including identifying and developing the capabilities.Take complete ownership of account, quality and deliverablesAble to perform risk mitigation and design proactive actionsSuperior project management and client interaction skillsGood acumen with escalations handling