Study Start Up Associate I

“At ICON, it's our People that set us Apart”

Are you passionate about improving the quality of human life? If so, we invite you to join us in creating a healthier world tomorrow.

ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.

We started as a team of 5 members in 1990 & today we are ranking at top 4 worldwide based on revenue of 2015. Currently we have 12200+ employees across the globe. ICON is a $1.575bn company having its presence across 89 offices in 37 countries.

Job Title                                  : Study startup associate I  

Reporting to                            :  Manager

Type of Employment              : Full Time

Location                                  : Trivandrum, office based

Summary:

Responsible for the review and approval of site level critical documents which are part of the Critical Document Package (CDP) for Investigational Product (IP) release in accordance with ICH/GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines and sponsor requirements.

Key Responsibilities & Duties:

·         Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

·         As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

·         Perform high quality CDP reviews according to the process defined in SOP SST004 titled “Critical Documents Collection, Critical Document Package (CDP) Approval and IP Release.

·         Provide SSU Lead/designee with CDP Requirement Sheet to discuss with the Sponsor.

·         Update CDP Requirement Sheet during the start-up phase of studies in consultation with the SSU Lead/designee.

·         Customize final Critical Document Package/IP Release Checklist and Global CDP Review Worksheet including any Sponsor, Country and Study Specific requirements.

·         Complete CDP reviews within defined and agreed timelines of receipt by the CDP Review Team/designee.

·         Complete review of CDP documents alongside the supporting Critical Document Package/IP release Checklist to confirm all the CDP documents are complete, consistent, current and in accordance with ICH/GCP and all applicable regulations, laws, and other guidelines and ethical standards.

·         Return to CDP Submitter any documents identified as incomplete, not current or inconsistent. x Sign and date the “Approved By” section of the Critical Document Package/IP Release Checklist to confirm approval of CDPs which are complete, consistent, current and in accordance with ICH/GCP and all applicable regulations, laws and other guidelines and ethical standards. X

·         Enter details of CDP review into the CDP Approval Tracker at completion of each review.

·         Upload approved CDPs to agreed electronic filing system.

Experience required

2 to 3 years pf experience in ICH/GCP

Deep knowledge in Documentation

Academic or Trade qualifications:

Any life science

Benefit Working with ICON:

Other than working with a great team of smart and energetic people, we also offer a very competitive salary and benefits package that includes an excellent pension scheme, private health care, and life assurance and staff recognition schemes. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. 

PROCESS

Technical and competency selection:

When you spot an opportunity you’re interested in and submit an application, one of our Talent Acquisition Specialists will contact you to evaluate your suitability for this position, as well as for other openings within the business.

The evaluation will look at your technical skills and your competencies – for example, delivering excellence.

Interview

After this, we’ll let you know if we’ll be progressing with your application. If you have been successful at this stage, we will talk you through a telephone interview. This will then be followed by an interview with our Hiring Manager, either face to face or by tele-conference.

Offer

If you’re successful, we will notify you with details of the offer, talk you through our culture and values, answer any questions you may have – and above all, welcome you to the ICON team.