Job Description
Must Have
Job Description
• Responsible for developing Specification and Data Management documents with quality and accuracy of delivery, timelines and efforts with minimal guidance
• Create study specific User Specifications Requirements and Edit Check Specifications for validation process
• Responsible to perform User Acceptance Test, provide summary checklist and Query Management
• Be able to extract information from authentic sources (Protocol, Specifications and DM documents) and recreate the draft with/without guidance
• Proficient in Protocol review and provide input and assistance in the design of Case Report Forms
• Be able to perform system generated query management and Creating manual query management plan
• Able to perform study close-out activities with minimal assistance
• Collate reviewer comments, adjust the content of the document as required based on internal/external input, and prepare the final version
• Follow the best practices while executing projects in the team with regard to processes, communication (internal & external), documentation and technical requirements like language, grammar, style, content search, summarizing
• Participate in client calls from content perspective (more with a learning objective)
• Communicate with the lead and collaborate with other stakeholders on project requirements and deliverables and project challenges
• Prepare first draft, summarize relevant information, and develop content outlines as per the client requirements and appropriate content for the target audiences for simple assignments