Study Start Up Associate I

ICON is hiring for Study start up group

“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 building 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 14000+ employees across the globe. ICON is a $2bn company having its presence across 97 offices in 38 countries.

Job Title : Study start up associate I

Reporting to : Manager

Type of Employment : Full Time

Location : Chennai, 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 centre around our dedication 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.

·         Liaise with internal ICON and external (e.g. site personnel, IRBs etc.) stakeholders to deliver maintenance support activities during the clinical trial.

·         Prepare, coordinate review, submit and QC submissions to ethics, regulatory and other authorities to obtain clinical trial authorizations and approvals.

·         Collect critical documents for maintenance activities. Assist with finalization/approval of country and site Specific SIS/ ICFs in collaboration to the LIC team.

·         Perform site contract negotiation including of budget and contract amendments, as required. Upload final documents to agreed electronic filing system (Activate, TMF, etc.) and perform updates as required to systems e.g. CTMS. Lead activities/ tasks and complete the deliverables within timelines, as needed.

Experience required

2+ years of experience in B&C related domain (within a CRO/ Pharma)

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 passionate about 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.