Clinipace Medical Data Associate
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Clinipace Medical Data Associate – Life Science Job Opening

Clinipace Medical Data Associate – Life Science Job Opening. BSc Life Science Job Openings. Life Science Job Opening. BSc Jobs. Interested and eligible applicants can check out all of the details on the same below:

Job Title: Medical Data Associate

Job Location: Thiruvananthapuram, Kerala, India

Job Overview:

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:

Job Duties and also Responsibilities:

  • Remaining current with the 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 life science or 3 to 4 years of equivalent experience

Experience:

  • Experience with medical terminology preferred
  • Highly desirable: Previous experience with the query entry, follow-up and closure in EDC system
  • One or two years of experience in Clinical Data Management.

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: the 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 – the 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

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