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Senior Clinical Data Associate

3+ years
Not Disclosed
10 Feb. 20, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Senior Clinical Data Associate

Location: Ahmedabad, Gujarat, India
Requisition Number: 582
Type: On-site

Company Overview:
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our mission is to improve the lives of all those touched by clinical research, driven by foresight, character, resilience, and innovation. Through decades of expertise, we help our clients achieve better outcomes with customized solutions and proactive collaboration.


Position Overview:
The Senior Clinical Data Associate (CDA) is responsible for managing and performing all data review activities for clinical studies. The Senior CDA supports the Lead Data Manager with key data management tasks and ensures high-quality deliverables within specified timelines.


Key Responsibilities:

  • Exceed expectations and responsibilities of a Clinical Data Associate.

  • Assist in the creation of data management plans (DMP), edit check specifications, eCCGs, data review listing specifications, and other start-up documents.

  • Perform user acceptance testing (UAT).

  • Support EDC module integrations and setup (ePRO, Randomization, Dispensing, etc.).

  • Review eCRFs in the database to ensure data consistency and completeness.

  • Conduct manual data review and data listing reviews as defined on assigned studies.

  • Review and respond to site queries; issue re-queries as needed.

  • Generate and resolve manual queries.

  • Communicate potential data issues to appropriate data management personnel.

  • Perform reconciliation of SAEs and external vendor data for assigned studies.

  • Identify data trends, report inconsistencies, and collaborate to implement corrective actions.

  • Manage user accounts and perform user account management tasks.

  • Collect and report on study metrics.

  • Perform data entry and quality control review of local lab data.

  • Complete quality control (QC) reviews and EDC archival tasks.

  • Guide team members on departmental and company Standard Operating Procedures (SOPs).


Qualifications:

  • Minimum of 3 years of direct data management experience in pharmaceutical development or CRO environments.

  • Bachelor’s Degree preferred; relevant work experience may be substituted for a degree.

  • Working knowledge of CDASH standards.

  • Excellent oral and written communication skills.

  • Strong organizational skills and attention to detail.


Why Join Advanced Clinical?

At Advanced Clinical, we are committed to diversity and inclusion, believing that a diverse workforce strengthens our efficiency and relevance. We encourage individuals from varied backgrounds and cultures to join our team, fostering a collaborative, inclusive, and innovative environment.


How to Apply:

Interested candidates should apply online through our careers portal. We look forward to welcoming you to our dynamic and mission-driven team!