Study Start Up Associate

1 month ago

Mumbai Maharashtra, India ICON Full time

The Study Startup Associate is responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Pfizer standards. Responsibility within a country and may span over more than 1 country depending on the geographical region and business needs.

**What you will be doing**:
Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation.- Register investigator sites and Pfizer stakeholders in Pfizer registries and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready.
- Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in SIP or reviewing/completing critical information Sheet inclusive of but not limited to Investigator Initiation Packages (IIP) essential documents components, Site contracts contacts, clinical supply shipment information, payment information, IRB submission and status.- Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable.- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
- Manage and coordinate with other supporting roles to ensure timely site activation and operational activities.
- Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements.

**You are**:

- BS/BA or bachelor’s degree in life sciences preferred
- Minimum 2 years relevant experience in clinical trial management.
- Experience working in the pharmaceutical industry/or CRO in study site activation or startup.
- Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations.- Must be fluent in Local language and in English. Multilanguage capability is an asset.
- Good technical skills and ability to learn and use multiple systems.
- Demonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process details.

**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 maximise 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

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