Tamil Nadu Product listing Jobs – 127 Open Jobs Today

Senior Clinical Data Co-ordinator
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Senior Clinical Data Co-ordinator

Navitas Life Sciences -
Chennai, Tamil Nadu

Apply Now

Job details

Full-time

Qualifications

Quality assurance
Bachelor's degree
Data management
Data entry
Pharmacy

Full job description

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

Apply Now

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