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 e. TMF 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 availabl... more details
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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 CRO
studies
Proactive in researching eTMF or available resources to find answers to the queries at indexing and review
stage, before they are escalated to PM/client
Conduct retraining for team members as required on an ongoing basis keeping PMs and Senior TMF Quality
Specialist in loop.
Conducting trainings for new hires in collaboration with CDTM
Ensure smooth functioning of assigned projects from start to end
Manages Q&As for assigned projects
Coordinate with PMs for requirements of updates in system configurations or mapping documents
Assist the PMs in client meetings or provide them with required data on assigned projects as needed by the
clients
Assist Senior TMF Quality Specialist in performing internal audits when needed
Review audit plans before finalizing with the client and ensure the internal audits are performed as per the
audit plan
Suggest improvement to the processes and performances of fellow team members
Mentor fellow team members as required
Coordinate with global team members to ensure the consistency in assigned projects
Assist with User Acceptance Testing during product development and release
Work with cross functional teams including Project Management, Business Development, Client Services,
Development, and IT on the implementation and management of client projects
Gather and provide feedback on features and enhancements that may be needed on an ongoing basis to
Development Team
Serve as part as the Project Team on client projects
Become an expert in the TMF Reference Model and stay current on regulatory changes
Become 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 activities
Respond 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 estimates
Take 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 service
Line manage individual employees or groups, as required
Set and fulfill client expectations
Perform other special projects or duties when required
Complete 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 regulations
Expert in TMF filing best practices, clinical documentation at all levels
Superior written and spoken communication skills in English
Proficiency in Microsoft Office (Word, Excel, Outlook), and knowledge of eClinical technologies
Proficiency in Document Management (Adobe professional, knowledge of Scanning, indexing, using ISI Tools
and Capture Perfect)
Support supervisor in people management and administrative task.
Minimum bachelor’s degree or its equivalent
Minimum 5 years of experience in the Life Sciences industry
Experience with essential documents and other study documentation
Hands-on experience project management practices and priority setting
Proficient in client interaction and deliverables
A plus if you have...
Previous employment in Pharmaceutical, CRO, Medical Device, or Investigative Site or eTMF
Experience in a leadership role, mentoring, training, performance evaluations, etc.
Minimum 6 months of experience of supporting line management
Ability to multitask in a fast-paced environment
Work well with people from a variety of different backgrounds and cultures
Build relationships with clients and co-workers
Can work independently and as part of a team
Take proactive measures to solve problems and commit to a high level of service
Able to manage team building, coordination, and utilizing the skills
Skilled in performing quality assessment and designing corrective actions
Excellent project management and client interaction
Expertise in handling escalations from internal and external clients
Proficient 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.
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