Job Description

Job Title: Clinical Data Associate
Job Location: Trivandrum, Kerala. (Office based) Job Overview: The Clinical Data Associate assists the Clinical Data Manager with the process of cleaning and validating data in clinical trials in accordance with Clinipace SOPs, Good Clinical Practice, ICH Guidelines and sponsor requirements.
Job Duties and Responsibilities: The specific job duties of a Clinical Data Associate may include but are not limited to:

• Assists in reviewing, processing and updating query responses, as needed or assigned
• Assists with start-up activities including:
  • Creation and entry of test data for data entry screen validation
  • Set up of patient and investigator information
• For specified projects assists on some data management activities as detailed below and performs activities in accordance with our SOPs, Good Clinical Practice, ICH Guidelines and study documentation.
  • Study status tracking
  • Data Entry
  • Review of data listings
  • Identification of data issues and query generation
  • Updating of database with query resolutions (on paper studies only) based on platform need.
  • Archiving of critical documents on an ongoing basis
• Assists with maintaining and updating Data Management Plans and any other relevant Data Management Documentation.
• For any legacy paper studies, assists with reviewing and processing Data Clarification Forms, reviewing data listings and quality control reports and updating clinical databases
• Participates in assigned study finalization activities including:
  • Reconciliation
  • Critical item review
  • Quality Control
  • Archiving
• Participation in appropriate project team meetings
• Manages time in accordance with allocated hours for task
• Review and awareness of core study documents- Protocol, Data Management Plan, CRF completion guidelines, DVP, etc. as applicable for the study
• Awareness and implementation of the data reconciliation requirements as documented in the associated Data Management documents.
• Awareness and support for data lock timelines and all associated requirements per the DMP and data lock checklist.
• Participates in departmental and organizational meetings and initiatives
• Supports and tracks budget adherence in cooperation with Finance to ensure the assigned deliverables are meeting targeted margins and utilization
• Continuous improvement of departmental processes and procedures to ensure DM is consistently maximizing efficiencies, leveraging technology and incorporating innovation to optimize delivery
• Maintains working knowledge of regulatory requirements/guidance as well as industry leading best practices to ensure Clinipace DM procedures are in line with industry expectations

Other duties as assigned Supervisory Responsibilities: This job involves no supervisory responsibilities for other employees or contractors. Job Requirements:

• Education
  • College graduate with a life science, computing or nursing qualifications preferred, or 3 to 4 years’ equivalent experience
• Experience
  • Experience with medical terminology preferred.
• Skills/Competencies
  • Excellent organizational skills
  • Strong written and verbal communication skills
  • Exceptional attention to detail
  • Strong computer skills, including Microsoft Office
  • Good problem-solving skills
• Capabilities
  • Flexibility - willing to change assignments and work focus to accommodate project demands
  • Team player – effective proactive participant as a team member.
  • Work evening and/or weekends on occasion as needed by the project

#LI-XX1 V2 The company will not accept unsolicited resumes from third party vendors.