Clinical Data Svs Sr Analyst

Clinical Data Services Sr Analyst

Location: Bengaluru
Experience: 5–8 Years
Education: Any Graduate

Job Description

We are looking for a Clinical Data Services Sr Analyst to support clinical research and life sciences R&D initiatives. The role involves providing medical and clinical data expertise for trial oversight, safety and efficacy deliverables, data validation, statistical programming, and quality control.

Key Responsibilities

• Analyze and resolve moderately complex clinical data and programming-related problems.

• Review clinical trial protocols, study setup documents, submission documents, and output specifications.

• Provide medical expertise for trial oversight and safety-related activities.

• Develop and execute SAS programs and standard macros for generating SDTM and SDTM-like datasets, tables, listings, figures, and trial-specific outputs.

• Perform developer testing and validate datasets and outputs according to defined standards and SOPs.

• Conduct QC checks for standard and non-standard safety and efficacy deliverables.

• Apply clinical programming and data standards to improve efficiency and consistency across studies.

• Maintain project, validation, programming, and study documentation in accordance with SOP requirements.

• Collaborate with study leads, Senior Statistical Programmers, programmers, offshore teams, and onshore/client stakeholders.

• Act as an interface between study teams and client stakeholders to ensure smooth study execution.

• Work independently on routine assignments while seeking guidance for new or complex activities.

• Mentor and guide new team members and support onboarding and technical/process-related queries.

• Conduct Service Readiness Assessments and support resource management activities.

• Assist Statistical Programming Managers and Service Delivery Leads with operational reporting and daily activities.

• Participate in training, business excellence initiatives, and organizational task forces.

• Work in rotational shifts as required.

Required Skills

• Clinical Data Services

• Medical Monitoring

• Clinical Data Management

• SAS Programming

• SDTM

• Clinical Trials

• Data Validation

• Quality Control (QC)

• Statistical Programming

• Safety & Efficacy Data

• Strong Analytical Skills

• Problem Solving

• Communication Skills

Preferred Profile

Candidates should have strong analytical and problem-solving abilities, good written and verbal communication skills, and experience working with clinical trial data, SAS programming, clinical data standards, and quality control processes. Experience collaborating with cross-functional and client-facing teams will be an advantage.

​Important 

• Ex-TCS employees are not eligible to apply.
  
• PAN and Date of Birth (DOB) are mandatory for profile creation.