Director, Study Start Up

Director, SSU Central Services

Location: Chennai/ Bangalore/Trivandrum, office-based

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

ICON plc, a leading global Contract Research Organization employing 15,000 people in 40 countries. ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.

About the Director, SSU Central Services at ICON:

The Director, Study Start-Up Central services, is responsible for implementing an effective structure and processes to ensure accelerated site activation and maintenance timelines for customers, and with highest quality. This involves monitoring and improving key performance metrics around reduced cycle times, predictability of delivery, and enhanced productivity, and will comprise oversight over key customer, operational and financial activities.

In addition to providing operational leadership to the group, the Director, Study Start-Up Central Services will be knowledge in local regulations, act as a senior counterpart to internal and external customers, and ensure growth of their customer base and staff levels.

Responsibilities includes:

* As a Director, expected to recognize the importance of and create a culture of continuous improvement with a focus on quality, streamlining our processes, adding value to our business and meeting internal and external client needs. Act as a change agent within the department to align with goals.

* Lead delivery of accelerated site and study start-up and maintenance, as well as due diligence with highest quality standards, to exceed customer expectations. This involves monitoring and improving key performance metrics around accelerated cycle times, predictability of timely delivery, and enhanced productivity, and will comprise oversight over key activities such as CDP / regulatory approval, maintenance of critical document package (CDP) for amendments, EC/IRB submission/approvals for amendments, ICF, budget and contract updates for amendments, and IP release.

* Drive system compliance. Use of data analytics to assess metrics trending and proactively mitigate concerning trends with focus on speed and quality

* *Accountable for appropriate resourcing and corresponding utilisation, including appropriate forecasting, to ensure staffing levels are at all times conducive to operational and financial success. This includes participation and decision-making in the hiring process whilst keeping business need and profitability in mind.

Responsible for growing the team locally to provide global services.

* *Ensure that budget parameters are adhered to, resulting in financial health of projects, portfolios and/or department. Review budgets for the purpose of proposals and sales when and as required.

* *Ensure quality by pro-actively assessing compliance and implementing measurable solutions and preventive actions. Communicate on all applicable quality issues to keep Executives and representatives informed of all critical issues.

* Act as customer/portfolio or country level client liaison and escalation point of contact; resolve customer relationship issues.
* Facilitate increased productivity whilst maintaining quality levels.

* Work closely with teams on Business Development opportunities to support the growth of the assigned portfolio and/or country(ies) and provide regional/client based knowledge to achieve success.

* *Develop key relationships with the wider business at regional/global level. Lead key initiatives, or collaborate on global initiatives, across the Start Up group. Ensure best practice and continuity in the ICON services.

To succeed you will need:

A minimum of 10 -15 years relevant research experience required including rich experience in Clinical Trials, Regulatory and Study start up/maintenance and 5+ years of line management experience preferably holding a Director /Associate Director position currently. Must have strong expertise in CDP / regulatory approval, critical document package (CDP) review, EC/IRB/ ICF requirement knowledge, as well as budget and contract negotiations, and IP release. Industry experience a must.

Benefits of working at ICON:

ICON offers an exceptional benefits package that includes a comprehensive health plan, retirement plans, highly competitive pay, corporate bonus plan, time away from work, and other incentives. We provide you with the technology, innovation and resources to be successful in ensuring utmost compliance and operational efficiencies

What's Next?

Following your application if you are successful you will be invited to an initial telephone interview with one of our dedicated recruiters who will be able to provide you with more details of this opportunity.

We invite you to review our opportunities at www.iconplc.com/careers.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.