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ICON plc

2 - 6 Years

4.7 - 7.5 Lacs per year

Bangalore

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

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Work/Life Balance

Time management

challenging projects

Insurance

ICON plc is a global leader in healthcare intelligence and clinical research, committed to shaping the future of clinical development. With a focus on innovation and excellence, ICON fosters a diverse and inclusive work culture. Joining ICON means being part of a mission-driven organization that helps advance clinical trials and brings life-changing pharmaceutical and biological products to patients worldwide.

Responsibilities in the Job
As a Study Start-Up Associate (Level I & II), you will play a crucial role in facilitating the initiation of clinical trials by ensuring that research sites and investigators are prepared for trial execution. Key responsibilities include:

  • Preparing and submitting essential regulatory documents, including clinical trial applications and ethics committee submissions.
  • Coordinating with internal and external stakeholders to secure necessary study approvals.
  • Maintaining accurate records of regulatory submissions and approvals.
  • Supporting the development of study-related documents, such as protocols, informed consent forms, and investigator brochures.
  • Reviewing and negotiating clinical site investigator contracts and budgets.
  • Acting as a liaison between investigative sites, sponsors, and internal personnel.
  • Providing training and mentorship to junior team members and acting as a consultant on budget and contract development processes.

Qualifications Required
Candidates should meet the following criteria:

  • A minimum of 2-6 years of experience in clinical research, specifically in essential document review for study start-up.
  • Thorough knowledge of ICH-GCP guidelines.
  • Experience working across multiple countries is an added advantage.

Skills Needed

  • Strong negotiation and communication skills, particularly for handling Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries.
  • Proficiency in reviewing and approving country and site-specific informed consent forms (ICFs).
  • Ability to coordinate effectively with diverse teams and stakeholders.
  • Detail-oriented with excellent organizational skills to manage regulatory documentation.

Application Link

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