Senior Clinical Data Co-ordinator

Job Description

We are looking for a Senior Clinical Data Co-ordinator who will act as the Primary Data Management point of contact for the day to day activities relating to the study. The successful candidate will:

  • Oversee and co-ordinate tasks delegated to the study team members
  • Provide training to new data management personnel on data management processes and procedures
  • Plan, manage, control, and perform data processing and management activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial Sponsors’ requirements
  • Create and develop study specifications, implementation, testing of eCRF or paper CRF edit checks and data review, overview listings
  • Author and review the Data Management Plan (DMP)
  • Design and review case report forms (CRFs/eCRFs)
  • Participate in the database design process including User Acceptance Testing (UAT)
  • Review data, issue and resolve queries. Assist Clinical CRO, sponsor or investigative site with resolving queries
  • Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures, and medicinal products
  • Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks
  • Co-operate and assist the Quality Assurance Department with quality control audits on assigned databases. Validate and disseminate real-time study monitoring reports to sponsor and internal team members
  • Specify and review database edit check specifications for assigned studies
  • Lead efforts in developing and maintaining standard database integrity checks for common modules as well as for therapeutic/drug area specific modules
  • Define and monitor clinical trial data flow and quality control processes in accordance to corporate Standard Operating Procedures (SOPs), Good Working Practices, and unit guidelines
  • Provide training to new staff, study site and sponsor personnel on data management processes and procedures, data entry and review with electronic data capture systems, data flow and quality control processes
  • Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documentation
  • Help in recruitment process in conducting interviews and shortlisting the candidates

Desirable Skills and Experience

  • Experience in Clinical Data Management is required

Chennai, India

Bachelor’s Degree in Pharma

Junior

Clinical Research

Full Time

18 Feb 2021