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Study Start Up Associate Ii

2+ years
Not Disclosed
10 Aug. 21, 2024
Job Description
Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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

About the Role: Study Start Up Associate II - Bangalore, India

Company Overview

ICON plc is a global leader in healthcare intelligence and clinical research. Our mission is to shape the future of clinical development by fostering innovation and excellence in a collaborative and inclusive environment. At ICON, our ‘Own It’ culture is driven by core values of Accountability & Delivery, Collaboration, Partnership, and Integrity, ensuring that we deliver exceptional service to both clients and patients.

Position Summary

We are seeking a Study Start Up Associate II to join our Bangalore team. This role involves overseeing centralized document management processes, ensuring compliance with regulations, and maintaining accurate and timely site-related data. You will be responsible for preparing and submitting investigational product release packs, managing Trial Master File (TMF) documents, and communicating task progress. The role also requires flexibility to support additional tasks beyond document management.

Key Responsibilities

  • Document Review: Ensure site-level essential documents meet Sponsor and Investigator obligations and comply with ICON SOPs, Sponsor SOPs, country requirements, and ICH/GCP guidelines.
  • Data Management: Update clinical systems promptly and accurately, maintaining site-related data according to procedures and guidelines.
  • Investigational Product: Prepare and submit Investigational Product Release Packs.
  • TMF Management: Ensure accuracy and completeness of TMF documents, submitting them for filing during start-up.
  • Task Communication: Communicate progress on tasks in a timely and accurate manner.
  • Stakeholder Interaction: Collaborate effectively with internal stakeholders.
  • Compliance: Adhere to ICH-GCP guidelines, company and sponsor SOPs, project plans, and local regulatory requirements.
  • Flexibility: Support various tasks beyond document management as needed.

Qualifications

  • Experience: Minimum of 5+ years in Study Start Up (SSU) experience, with specific experience in EU CTR.
  • Document Review: Proven experience in reviewing essential documents.

Benefits of Working at ICON

At ICON, we prioritize the growth and development of our people. Our benefits package is competitive and includes:

  • Competitive Salary: Regular benchmarking against industry standards and performance-based annual bonuses.
  • Health Benefits: Comprehensive health insurance options for you and your family.
  • Retirement Plans: Competitive retirement planning options.
  • Employee Assistance: Global Employee Assistance Programme (LifeWorks) providing 24-hour access to a network of professionals.
  • Additional Benefits: Annual leave entitlements, life assurance, and flexible country-specific benefits such as childcare vouchers, gym memberships, and health assessments.

Our Commitment

ICON is an equal opportunity and inclusive employer. We are committed to a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require accommodations due to a medical condition or disability, please let us know through our request form.

Apply Now

If you’re interested in this role but unsure if you meet all the requirements, we encourage you to apply. There’s a chance you’re exactly what we’re looking for at ICON, whether for this role or others.

Current ICON Employees: Click here to apply.

Visit Our Careers Site: ICON Careers