Job Description – Senior Clinical Data Associate
Company:
Precision for Medicine – Clinical Solutions
Location:
Bangalore, Karnataka, India
Chennai, India
Job Type:
Regular, Full-time
Requisition Number:
5252
Position Summary
The Senior Clinical Data Associate supports all aspects of the clinical trial data management process from study start-up through post-database lock for assigned projects. This role follows Standard Operating Procedures (SOPs), Work Instructions (WIs), regulatory directives, and study-specific guidelines.
Responsibilities may also include database development, testing, and other data management activities.
Key Responsibilities
Project & Data Management
Act as support/back-up to Lead Data Manager (DM), ensuring timely task completion.
Perform data entry and quality control for paper-CRF studies, as required.
Review and query clinical trial data in line with the Data Management Plan.
Run patient- and study-level status reports and metrics.
Perform line listing reviews based on sponsor/Lead DM guidance.
Conduct SAE/AE reconciliation and liaise with vendors as needed.
Database & Documentation
Assist in developing CRF specifications and coordinate reviews with stakeholders.
Support clinical database builds and conduct UAT with quality-controlled documentation.
Specify requirements for edit checks (electronic/manual).
Maintain data management documentation with appropriate version control.
Assist with SAS programming and QC of programs within Data Management.
Medical Coding & Standards
Perform medical coding using MedDRA and WHODrug dictionaries.
Ensure consistency and logic in coded terms.
Apply knowledge of CDISC standards (CDASH, SDTM, ADaM) where relevant.
Collaboration & Training
Train clinical research staff on CRF, EDC, and project-specific items.
Provide input into study protocols, SAPs, and CSRs as required.
Communicate effectively with sponsors, vendors, and project teams on data/database issues.
Train and mentor project team members, ensuring adequate onboarding.
Present in meetings, trainings, and software demonstrations as needed.
Process Improvement
Identify and troubleshoot operational problems using metrics, audit reports, and team feedback.
Contribute to SOP/process documentation development and updates.
Continuously drive efficiency and improvements in data management practices.
Qualifications
Minimum Required
Education: Bachelor’s degree or equivalent combination of education and related experience.
Experience: 5+ years in clinical data management or related field.
Skills:
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Strong organizational and communication skills.
Professional fluency in English (written & spoken).
Basic knowledge of drug, device, or biologic development and data management practices.
Preferred
Experience in clinical, scientific, or healthcare disciplines.
Proficiency in MedDRA and WHODrug coding.
Knowledge of CDISC standards (CDASH, SDTM, ADaM).
Experience in Oncology and/or Orphan Drug therapeutic areas.
Core Skills & Competencies
Strong understanding of ICH-GCP, regulatory guidance, and Precision Oncology SOPs.
Ability to motivate project teams and ensure deadlines are met.
Proactive in driving continuous process improvements.
Capable of resolving project-related issues and managing workload with minimal supervision.
High degree of self-motivation, professionalism, and accountability.
Excellent team collaboration and interpersonal skills.
Additional Information
May require occasional travel.
Performs other duties as assigned.
⚠️ Fraud Alert: Precision for Medicine does not extend job offers without prior communication through official recruiters, hiring managers, and a formal interview process. Beware of fraudulent offers misusing the company’s name.
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