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Senior Central Risk Manager (India)

Innovaderm Research
Innovaderm Research
10+ years
Not Disclosed
10 Jan. 30, 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

🌟 Now Hiring: Senior Central Risk Manager (India) 🌟

💼 Position: Senior Central Risk Manager
🏢 Industry: CRO - Biometrics
📍 Location: India (Remote)
Job Type: Full-time

🔎 Job Overview

The Senior Central Risk Manager is a key role responsible for developing and executing risk-based monitoring strategies in clinical research. This position focuses on ensuring data quality and integrity throughout the clinical trial lifecycle while applying Risk-Based Study Management (RBSM) principles.

🔑 Key Responsibilities

✔ Develop and update risk-based monitoring strategies based on project needs
✔ Collaborate with cross-functional teams to identify and mitigate risks
✔ Draft risk assessments and support finalizing Risk Assessment and Categorization Tools (RACT)
✔ Guide Project Managers in tracking and reviewing risks
✔ Advise on developing functional plans to mitigate risks effectively
✔ Conduct remote data reviews and statistical monitoring to ensure data integrity
✔ Facilitate internal and sponsor reviews, identifying complex risks and their mitigations
✔ Train study teams on risk assessment, centralized monitoring, and risk-based strategies
✔ Mentor peers and provide training to new team members
✔ Escalate risks or deliverables at risk to the Project Manager (PM)
✔ Provide strategic input on risk characterization and reporting

📌 Requirements

🎓 Education:

  • Bachelor’s degree in clinical research or related field (Master’s degree preferred)
  • Expertise in Good Clinical Practice (GCP), ICH E6 (R3) Guidelines, and regulatory requirements

🛠 Experience:

  • Minimum 5 years in risk management in a clinical research setting
  • Over 10 years in clinical monitoring, data management, biometrics, or project management

📜 Skills & Competencies:

  • Proficiency in Risk-Based Monitoring (RBM) processes and tools
  • Advanced analytical and data visualization skills
  • Mastery of MS Excel and Lean Six Sigma knowledge
  • Excellent communication, negotiation, and leadership skills
  • Strong project management and cross-functional collaboration abilities
  • Ability to prioritize tasks, manage multiple functions, and adapt to changing project demands

🎯 Perks & Benefits

Permanent full-time position
Flexible schedule
Vacation and personal days
Home-based position
Ongoing learning & career development

📌 Company: Innovaderm (Specialized in Dermatology CRO Research)
📌 Legal Requirement: Applicants must be legally eligible to work in India

📩 Apply Now!