Description
Responsible for QC and review of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO studies.
Responsible for resolving queries of the QC1 and QC2 reviewers before they are escalated to the PM and senior document specialists.
Be proactive in researching eTMF or available resources to find answers to the queries of QC1 and QC2 reviewers.
Assist senior document specialists for conduction trainings for new joinees, re-training for team members as required on an ongoing basis.
Assist study leads to ensure smooth functioning of assigned projects from start to end.
Assist study leads for managing QAs for assigned projects.
Coordinate with PMs for requirements of updates in system configurations or mapping documents.
Assist the PMs for client meetings or provide them required data on assigned projects as required by the clients.
Assist senior document specialists for performing internal audits.
Review audit plans before finalizing with the client and ensure the internal audits are performed as per Audit plan.
Perform random QC checks on assigned projects to ensure eTMF quality.
Come up with valuable suggestions for improving the processes and performances of fellow team members.
Be able to take up mentorship role for fellow team members as required.
Coordinate with all the team members across the globe and ensure that all the teams function in a similar way across a project to ensure consistency.
Assist with User Acceptance Testing during product development and release
Work on 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
Participate and 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 GM, Life Sciences Solutions, Project Management and Development to recommend new features and functionality 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.
Set and fulfill client expectations.
Perform other special projects or duties when required.
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