Business Operations Associate – Site and Study Start Up Specialist

ICON plc

Study Start Up Associate II at ICON leading clinical trial initiation while ensuring regulatory compliance and facilitating innovative treatments. Collaborating with stakeholders to manage start-up activities and streamline processes.

Posted 7/26/2026full-timeRemote • 🇮🇳 IndiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in regulatory affairs and clinical trial processes, with a strong focus on study start-up activities and compliance with ICH-GCP guidelines. Proven ability to manage stakeholder communications and maintain accurate regulatory documentation.

Highest-signal resume keywords

Regulatory Document PreparationClinical Trial ApplicationsStudy Start-Up ActivitiesProject ManagementCommunication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory RequirementsClinical ResearchICH-GCP GuidelinesRegulatory SubmissionsStudy Initiation

Soft Skills

Organizational SkillsInterpersonal SkillsCollaboration

Industry Keywords

Life SciencesRegulatory AffairsClinical TrialsProcess Improvement

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively
Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
Coordinate and liaise with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation
Manage and maintain comprehensive and accurate records of regulatory submissions, approvals, and correspondence
Provide guidance and support to study teams on regulatory requirements and best practices for study start-up activities
Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency

Requirements

What you’ll need

Bachelor's degree in life sciences or a related field
Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
Willingness to travel as required (approximately 5%)

Benefits

Comp & perks

Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways