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Senior Clinical System Lead

4-7 years
Not Disclosed
10 May 17, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Job Title: Senior Clinical System Lead
Company: ICON plc – Strategic Solutions Biometrics Portfolio
Location: Bangalore (On-site only)
Job ID: 2025-118055


About the Role:

ICON plc is currently hiring a Senior Clinical System Lead to play a crucial role in defining and managing the end-to-end clinical data journey. This includes identifying data sources, coordinating ingestion into the client ecosystem, and resolving challenges to maintain data consistency, understanding, and integrity.

You will be a key member of the study team, offering technical and procedural leadership for data ingestion and ensuring the integrity of clinical data custody while collaborating with vendors, CROs, and internal stakeholders.


Key Responsibilities:

  • Identify and document participant data sources; create study data flow maps to illustrate the clinical data journey.

  • Act as the primary contact for nonstandard data ingestion, defining data demands and managing interactions with enablement teams.

  • Define and conduct data ingestion reconciliations in alignment with data transfer specifications.

  • Perform risk assessments on study-level participant data and advise study teams on risk mitigation strategies.

  • Ensure appropriate data is collected and provide guidance and education to study teams.

  • Support digital health technologies and eSource data by offering setup support and input to long-term solutions.

  • Assess and define capabilities of strategic vendors to support data ingestion and quality; contribute to vendor evaluations.

  • Collaborate with data enablement teams on ingestion, harmonization, transformation, validation, and automation of clinical data.

  • Drive process improvement by ensuring compliance with current technologies and regulatory guidelines.

  • Participate in initiative implementations including digital protocols, automation, tokenization, and workflow optimization.

  • Adhere to and promote the data governance framework for participant data.


Qualifications & Experience:

  • Education: Bachelor's degree in Computer Science, Data Science, Statistics, or a related field.

  • Experience:

    • Minimum 4 years in clinical data management and data acquisition (preferably in BioPharma).

    • Ideal candidates will have 7+ years of relevant experience.

  • Strong understanding of modern data management platforms including Big Data, Lakehouse, and contemporary data integration techniques.

  • Proficient in handling clinical datasets, EDC, and non-CRF data.

  • Demonstrated ability to work with large and complex datasets, including both clinical and basic research data.

  • Strong analytical skills and experience in data harmonization and validation.


Important Notes:

  • This is not a remote role. On-site presence in Bangalore is required.

  • Freshers are not eligible for this position.

  • Please read the job description carefully before applying.