ICON plc Logo

ICON plc

Site Specialist I

Reposted 5 Days Ago
Be an Early Applicant
In-Office
2 Locations
Mid level
In-Office
2 Locations
Mid level
Support site activation by coordinating vendor access (eCRF, IVRS), managing CDP/submission documentation, maintaining study trackers, ensuring TMF completeness, applying ICH-GCP and SOPs, and collaborating with site partners and CRAs to enable timely study activation.
The summary above was generated by AI
Site Specialist - India, Office with flex

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Site Specialist I to join our dynamic team.

As a Site Specialist II, you will be responsible for supporting site activation activities, vendor coordination, and documentation processes to enable successful project delivery. This is an excellent opportunity for someone with foundational clinical operations experience looking to advance their career within a global, high-performing environment.

What You Will Be Doing:
  • Manage vendor access and activation activities, coordinating with external vendors (eCRF, IVRS) and internal stakeholders.

  • Handle CDP and submission documentation, ensuring accuracy and compliance throughout the activation process.

  • Maintain and update study trackers, ensuring all activities and milestones are accurately captured.

  • Collaborate closely with Site Partners, CRAs, IHCRAs, and CTAs to optimize study performance and ensure timely activation.

  • Work with cross-functional teams to forecast and track Site Activation plans, ensuring accuracy within ICON’s systems.

  • Participate in internal study review meetings to support risk identification, mitigation, and action planning for site activation.

  • Ensure Trial Master File (TMF) completeness and quality through timely submission and quality control review.

  • Apply proficient knowledge of ICON SOPs/WPs, ICH/GCP, and applicable country regulations/guidelines to ensure compliance across all activities.

  • Perform other duties as assigned to support broader project or departmental goals.

Your Profile:
  • Bachelor’s degree in Life Sciences or a related discipline.

  • Minimum 3 years of experience in clinical research, site operations, or clinical documentation management.

  • Solid understanding of the clinical trial process, including documentation and site activation workflows.

  • Familiarity with vendor systems (eCRF, IVRS) and administrative coordination.

  • Strong organizational and documentation skills with attention to detail.

  • Ability to collaborate effectively with multiple stakeholders in a fast-paced, matrixed environment.

  • Working knowledge of ICH-GCP guidelines, regulatory requirements, and internal SOPs/WPs.

#LI-KT1

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements

  • A range of health insurance offerings to suit you and your family’s needs.

  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

  • Life assurance

  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of 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, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

Top Skills

Cdp
Ecrf
Ivrs
Tmf

ICON plc Chennai, Tamil Nadu, IND Office

200 Feet Radial Rd, MCN Nagar Extension, Chennai, Tamil Nadu, India, 600097

Similar Jobs

3 Minutes Ago
Remote or Hybrid
India
Senior level
Senior level
Fintech • Professional Services • Consulting • Energy • Financial Services • Cybersecurity • Generative AI
Lead automation testing: design and implement Java-based automation frameworks (Selenium, TestNG, JUnit, Cucumber), create test plans/cases/suites, perform API and database validation using SQL, debug issues from logs, report and prioritize defects, and collaborate with Agile teams to define testing approach and risks.
Top Skills: BddBrowserstackCaptureConfluenceCucumberJavaJIRAJunitPostmanSauce LabsSeleniumSelenium GridSQLTddTestngZephyr
3 Minutes Ago
Remote or Hybrid
India
Senior level
Senior level
Fintech • Professional Services • Consulting • Energy • Financial Services • Cybersecurity • Generative AI
Lead business analyst activities for payments modernization using Pega: gather and document requirements, produce impact assessments, write test scenarios, liaise with stakeholders and vendors, and support implementation, testing and production issue analysis.
Top Skills: Aci MtsAdmiAgileCamtIso 20022PacsPainPayments HubPegaReal-Time PaymentsSepaSwiftUpf
3 Minutes Ago
Remote or Hybrid
India
Entry level
Entry level
Fintech • Professional Services • Consulting • Energy • Financial Services • Cybersecurity • Generative AI
Provide L1 functional support for banking applications in a 24x7 environment: monitor, log, and triage incidents; perform initial troubleshooting and root-cause analysis; analyze logs and transaction data; produce RCA reports; escalate to L2/L3; maintain documentation and knowledge base; work rotational/night shifts.
Top Skills: ItilJIRARemedyServicenow

What you need to know about the Chennai Tech Scene

To locals, it's no secret that South India is leading the charge in big data infrastructure. While the environmental impact of data centers has long been a concern, emerging hubs like Chennai are favored by companies seeking ready access to renewable energy resources, which provide more sustainable and cost-effective solutions. As a result, Chennai, along with neighboring Bengaluru and Hyderabad, is poised for significant growth, with a projected 65 percent increase in data center capacity over the next decade.

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account