ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

*Travel (approximately 15%) domestic and/or international. Anticipated activities may include attendance at Bid Defenses, Kick-Off, Investigator or study team meetings.

Attend BID Defiance meetings, as directed, to provide strategic study start up advice.

*Attend Kick Off Meetings, for all assigned studies, to provide strategic input into the study start up discussions

Global Contracts Lead to expedite contract negotiations:

Responsible for Study Start Up activities for site contracts and budgets in accordance with agreed budgeted hours, manage and escalate any significant variation to study budgets.

*Draft contract execution plan (including other local study start up requirements) and monitor the execution of the plan including any revised timelines.

*Work with key parties to draft mitigation plans against contractual targets for key milestones

*Responsible for the inclusion of the Study Start Up Plan in regards to site contracts and budgets in to the Project Management Plan to be shared and agreed with the sponsor.

*Fully accountable for the implementation of the Study Start Up Plan for site contracts and budgets all assigned studies

*Responsible for the Study Start Up element for site contracts and budgets of the Project Communication Plan.

*Plan, coordinate and drive all study start up activities as defined by the SOW from site identification list to IP release to achieve the agreed/contracted deliverables and timelines in all countries including:

Accountable for co-ordinating the timely negotiation of contracts and budgets with sites

Accountable for the co-ordination of translations for documents required for submission for assigned studies

Accountable for timely and accurate data entry of all study start up activities in the appropriate clinical trial management system

Accountable for the timely follow-up for queries made by CA/EC on assigned studies

Accountable for the collection of critical documents required for IP Release on assigned studies

*Ensure adherence to the SOW and the site activation budget as per the costing model.

Site Activation Lead (Contracts Manager)

REMOTE POSITION - ANYWHERE IN US

The role

• Lead clinical trial start-up activities by understanding the client objectives and assist in the development of the plan for country and site distribution

• Oversees day to day delivery of all aspects of site activation in the projects assigned.

• Ensures that each project has a site activation plan and that the study is being conducted in accordance with that plan and in an effective manner which meets sponsor timelines and expectations and is in compliance with ICON/client KPIs, ICON/client SOPs, reporting norms, appropriate regulations and ICONs quality standards

• lead sponsor initiatives such as kick-off meetings, bid defenses, project update and status calls, and other communications

• Utilize project management skills to optimize performance and collaboration to ensure successful study outcomes

What you need

• Bachelors Degree preferably in life sciences

• Minimum of 5 year of experience in a Clinical Research environment, focusing on Start Up experience

• Project management skill set

• Understanding of regulatory and submission processes in many different countries

• Excellent written and verbal communication

• Ability to work to tight deadlines

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. Thats why we are committed to developing our employees in a continuous learning culture one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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