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Study Start Up Associate I

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 I - Bangalore, India (Hybrid: Office-Based)

Company Overview

ICON plc is a global leader in healthcare intelligence and clinical research. We are committed to fostering an inclusive environment that drives innovation and excellence. Join us in our mission to shape the future of clinical development and make a significant impact on patient care.

Position Summary

We are seeking a Study Start Up Associate I to join our team in Bangalore. In this hybrid role, you will play a key role in managing and overseeing the start-up phase of clinical studies. Your responsibilities will include ensuring compliance with all relevant guidelines and managing essential documents for trial sites.

Key Responsibilities

  • Document Review: Review site-level essential documents to ensure compliance with ICON SOPs/WIs, Sponsor SOPs, country requirements, and ICH/GCP guidelines.
  • Data Management: Update clinical systems accurately and promptly, maintaining site-related data in accordance with procedures and guidelines.
  • Investigational Product: Prepare and submit Investigational Product Release Packs.
  • Trial Master File (TMF): Ensure accuracy and completeness of TMF documents by submitting them for filing during start-up.
  • Task Communication: Communicate task progress in a timely and accurate manner.
  • Organization: Maintain high organization levels in a dynamic environment with shifting priorities.
  • Stakeholder Interaction: Effectively interact with internal stakeholders and support various tasks beyond document management.

Qualifications

  • Experience: Minimum of 3 years of experience or understanding of clinical study start-up requirements and activities.
  • Skills: Experience with Essential Document Review/Greenlight Packages is required.

What ICON Offers

ICON values our people and strives to create a supportive culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer:

  • Competitive Salary: Regular benchmarking and performance-based annual bonuses.
  • Health Benefits: Comprehensive health insurance options for you and your family.
  • Retirement Planning: Competitive plans to help you save and plan for the future.
  • Employee Assistance: Global Employee Assistance Programme (LifeWorks) with 24-hour access to specialists.
  • Additional Benefits: Annual leave, 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 dedicated to providing a workplace free from discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you need 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. You might be 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