Contract Medical Data Associate

2 days ago

India Clinipace Full time

**Job Title**:Medical Data Associate (6 months contractual role)

**Job Location**: Anywhere in 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

LI-XX1

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

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