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Study Start Up Associate II

Thiruvananthapuram
Permanent
Reference: JR067318
Description

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?

We are looking for passionate, resilient, and inspiring individuals to join our team. As a member of the Study Start Up team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of the investigational, new pharmaceutical and biological products for clinical trials at their local practices.

The role

  • Preparation, Submission, Review and Approval of Critical Document Package (CDP)

  • Proficient essential document collection and review, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable country requirements and ICH/GCP guidelines

  • Preparation and submission of site level critical documents which are part of the Critical Document Package (CDP) to the Central CDP Review Team (CDPRT) and Sponsor

  • Review and approval of Critical Document Package (CDP)

  • Investigational Product (IP) release in accordance with regulatory and Sponsor requirements

  • Accurately forecast CDP Approval timelines and ensure they are reflected accurately in ICON's systems, proactively follow through for achievement to plan; provide risk assessment and contingency plans to mitigate impact if forecasted timelines are at risk, and escalate issues as soon as identified

  • Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF

  • Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems

What you need

  • Bachelor's degree in life sciences is preferred

  • Minimum 3 years of experience in study startup requirements and activities in a CRO preferably relevant experience in Critical Document Package review

  • Ability to liaise with the Study Start Up Lead, colleagues from other departments and clients, if required

  • Excellent written and spoken communication

Why join us?

Ongoing development is vital to us, and as a member of our team you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. We offer a very competitive salary and benefits package that includes an excellent recruitment plan, health coverage, paid time off, income protection insurance programs, and staff recognition schemes.

ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin

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