Central Risk Manager (Risk Based Central Monitoring)

5-8 years

Not Disclosed

Pune

10 July 24, 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

Central Risk Manager (Risk‑based Central Monitoring)

Company: Syneos Health
Location: Pune, Maharashtra, India
Work Mode: On-site (as per JD)
Compensation / Salary: Not disclosed in the job description

Job Summary (Clinical Research / Risk Management Focus)

Syneos Health is seeking a Central Risk Manager to drive Risk-Based Central Monitoring (RBM/RBQM) across global clinical programs. You will operationalize central statistical monitoring, define and track KRIs, QTLs, data anomalies, protocol deviations, and risk signals, and partner with study teams to implement proactive, data-driven mitigation strategies. This role is ideal for clinical data/risk leaders with strong knowledge of ICH-GCP, ICH E6(R2/R3), ICH E8(R1) and experience with central data surveillance, analytics, and operational risk governance in clinical trials.

Key Responsibilities

Lead risk-based central monitoring (RBCM/RBM/RBQM) strategy and execution across assigned studies and programs.
Define, configure, and routinely evaluate KRIs (Key Risk Indicators), QTLs (Quality Tolerance Limits), thresholds, and risk signals.
Implement and maintain central statistical monitoring (CSM) methodologies to detect data inconsistencies, site outliers, fraud indicators, and protocol deviations.
Collaborate with Clinical Operations, Data Management, Biostatistics, Medical Monitoring, and QA to triage/site actions, initiate CAPAs, and ensure ongoing risk mitigation.
Generate and interpret risk dashboards and analytics (e.g., Spotfire, Power BI, SAS/R, Python-based insights) to drive data-driven decision-making.
Author, review, and maintain Risk Assessment & Categorization Tools (RACTs), Risk Management Plans, Central Monitoring Plans, and associated SOPs.
Ensure compliance with ICH-GCP, ICH E6(R2/R3), ICH E8(R1), ISO 14155, and internal QA standards.
Support audit/inspection readiness, provide responses to regulatory queries, and contribute to inspection/audit CAPAs.
Train study teams on RBQM processes, signal detection, KRI interpretation, and central monitoring tools.
Contribute to continuous process improvement, automation, and standardization of RBM processes across portfolios.

Required Skills & Qualifications

Strong experience (years not stated in JD—apply if you have solid RBM/RBQM/RBCM exposure in clinical trials) in central monitoring, clinical data surveillance, or data-driven clinical risk management.
Deep understanding of ICH-GCP, ICH E6(R2/R3), ICH E8(R1), FDA/EMA RBQM expectations, and modern risk-based quality management (RBQM) frameworks.
Hands-on experience with KRI/QTL design, central statistical monitoring, data visualization, trend analysis, and CAPA management.
Proficiency with analytics/visualization tools (e.g., Spotfire, Power BI, JReview, SAS, R, Python) and EDC/eTMF/CTMS ecosystems.
Familiarity with MedDRA, coding dictionaries, safety data streams, and clinical data standards (CDISC/SDTM) is a plus.
Excellent cross-functional communication, problem-solving, and stakeholder management skills.
Ability to operate in a fast-paced, global CRO environment with multiple concurrent studies.

Perks & Benefits (as stated/highlighted by Syneos Health)

Career development & progression, technical and therapeutic area training.
Supportive, engaged line management and peer recognition programs.
Total Self culture promoting authenticity, inclusivity, and well-being.
Opportunity to work with a top global biopharma partner that supported 94% of Novel FDA Approvals (5 years), 95% of EMA Authorized Products, 200+ studies, 73,000+ sites, and 675,000+ trial patients.

Company Overview (SEO-Rich)

Syneos Health is a fully integrated biopharmaceutical solutions organization that brings together clinical, medical affairs, and commercial capabilities to accelerate biopharma success. With 29,000+ employees in 110 countries, Syneos Health partners with leading pharma and biotech companies to deliver data-driven, patient-centered clinical development.

Work Mode

On-site – Pune, India

Call to Action

Ready to lead global risk-based central monitoring and embed RBQM best practices across high-impact clinical programs? Apply now and help Syneos Health deliver faster, safer, and smarter trials.

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Central Risk Manager (Risk Based Central Monitoring)

Job Description

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