Medical Data Associate (contract role for 6 months)

Job Description:

Job Title: Medical Data Associate (contract role for 6 months)

Job Location: India (Remote)

Job Overview:

The Medical Data Associate is responsible to assist the Medical team with Medical data review, including but not limited to such activities as query entry, follow-up, and closure as well as assistance with other aspects of data review, cleaning, reports, summaries and slides, as requested.

Job Duties and Responsibilities:

Job duties may differ from project to project and are described in the contract, project-specific Plans (e.g., Medical Monitoring Plan and/or Medical Data Review Plan), and/or other documents agreed with the Sponsor. Job duties may include such activities as the following:

• Remaining current with company and project-specific training, as assigned
• Assisting with medical data review and managing (e.g. entering, closing) queries and re-queries in EDC
• Running query reports and following up on queries, as agreed
• Providing query reports to designated Medical team members
• Other query tasks, as provided by the Medical team
• Assisting with tracking of projects, their status and deliverables, as requested
• Assisting with Medical project-specific reports and/or preparations of slides and presentations
• Attending functional, internal and external project team meetings, when requested
• Documenting significant communications (e.g., interactions with sites, Sponsor, internal team members), as required
• Assisting with filing into the Trial Master File
• Other tasks and responsibilities, as assigned
  
  

Additional Tasks And Responsibilities (as Needed)

• Participating in Quality Control of Medical deliverables
• Participating in data reconciliation activities, when Medical input is needed
• Training new team members in query processes and tools, as requested
  
  

Supervisory Responsibilities:

No supervisory responsibilities

Job Requirements:

• Education
• College graduate with a life science, computing or nursing qualification preferred, or 3 to 4 years of equivalent experience
• Experience
• Experience with medical terminology preferred
• Highly desirable:
• Previous experience with query entry, follow-up and closure in EDC systems
• Skills/Competencies
• Advanced understanding of EDC systems, including Medidata RAVE
• Proficient in standard computer systems, including Microsoft Word, Excel, PowerPoint, and Outlook
• Basic understanding of ICH GCP, applicable regulatory requirements for study data, good documentation practices
• Time management: good sense of urgency, prioritization skills
• Team player: effective participant as a team member
• Attention to detail
• Excellent oral and written communication skills in English
• Integrity: Understanding and acting on principles of honesty, trust and fairness
• Contribution to and support for process improvements
• Capabilities
• Flexibility – willingness to change assignments and work priorities to accommodate project demands
• Ability to work remotely
• Ability to work outside usual business hours, on occasion, if needed by the project
  

The company will not accept unsolicited resumes from third party vendors.