Senior Clinical Data Analyst

7+ years

Preffered by Company

Hyderabad

10 Sept. 3, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Senior Clinical Data Analyst

Role Overview:

The Senior Clinical Data Analyst (SCDA) is an experienced professional responsible for leading and coordinating clinical data validation activities with a high degree of proficiency and autonomy. With over 7 years of experience, the SCDA provides technical expertise and operational leadership for data management (DM) activities, including data cleaning, validation, and documentation. Acting as a subject matter expert, the SCDA offers technical support and expert advice to internal teams and external sponsors. The role may also involve acting as a backup or fulfilling the Data Management Lead role as required.

Key Responsibilities:

Data Validation and Cleaning:
- Lead and oversee data validation activities, including data cleaning, review, and reconciliation during both the conduct phase and database lock.
- Manage query resolutions, manual/SAS listing reviews, and external vendor data reconciliation.
- Identify and highlight issues or risks to project delivery, supporting mitigation strategies as part of the Risk Management Plan.
Data Management Documents and Plans:
- Oversee the setup and maintenance of DM documents, ensuring compliance with SOPs and ICH/GCP guidelines.
Study Start-Up and User Acceptance Testing (UAT):
- Lead user acceptance testing for clinical database setups.
- Review study protocols and Electronic Data Capture (EDC) entry screens as needed.
- Provide input on data management timelines and coordinate DM operational activities throughout the project lifecycle.
Data Tracking and Entry:
- Track and review Case Report Forms (CRFs) and support data entry as needed.
Project Quality Management and Compliance:
- Ensure adherence to SOPs and ICH/GCP guidelines.
- Perform or lead quality control activities on databases and patient data according to business needs.
Training and Mentorship:
- Maintain training compliance for assigned roles, including on-the-job training.
- Address training needs based on development goals and provide relevant training to staff and project teams.
- Act as a mentor for other clinical data analysts.
Process and Project Improvement:
- Develop and implement project-specific tools to improve efficiency, including standard project directories and status reports.
Project Finance and Resource Support:
- Analyze operations-related project variances based on DM metrics and labor hour reports.
- Provide input on scope changes and resource needs.

Skills:

Proven ability to lead and collaborate with global and cross-functional teams.
Experience interacting with sponsors to address data issues and validation requirements.
Strong negotiation skills and ability to influence outcomes for mutually beneficial results.
Excellent problem-solving skills, including root cause analysis and decision-making in ambiguous situations.
Commitment to high-quality work with meticulous attention to detail.
Advanced time management and prioritization skills with a strong sense of urgency.
Exceptional interpersonal, oral, and written communication skills, tailored for diverse audiences.
Effective presentation skills.
Ability to rapidly learn and adapt to new technologies and processes.
Innovative approach to defining strategies for efficiency improvements.
Strong sense of accountability and ownership of responsibilities.
Fluent in written and spoken English.

Knowledge and Experience:

Advanced technical aptitude with strong proficiency in Microsoft Office Products.
In-depth understanding of data management processes and data validation flow.
Comprehensive knowledge of ICH-GCP guidelines, local regulatory requirements, and company SOPs.
Advanced knowledge of Clinical Data Management Systems (e.g., InForm, Rave, Veeva, DataLabs, ClinBase).
Awareness of Clinical Study Team roles and activities, including budget reviews and resource forecasting.
Extensive experience in the clinical research industry.
Advanced knowledge of medical terminology and coding dictionaries (e.g., MedDRA, WHODRUG).
Advanced understanding of Data Management operational processes, including study start-up, conduct, and close-out.
Proficiency in database setup activities, including Database Configuration Specifications and data validation.
Basic knowledge of SAS and data standards (CDISC).
Understanding of financial principles related to DM project financials and forecasting.
Proven experience in leading virtual/global DM operational teams.
Experience in the CRO industry is desirable.

Location:

Office-based in Bengaluru or Hyderabad.

Education:

Bachelor’s degree and/or other medical qualifications with relevant industry experience.

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