Study Start Up Specialist

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

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.

· Collaborate with internal and external business partners for country protocol feasibility(if applicable) and site feasibility assessment

· Drive the development of the Country& Site Activation Strategy Plan at study level across Phase

I-IV, with internal and external business partners

· Serve as the point of escalation to study teams for start-up process issues and facilitate resolution to issues identified

· Evaluate translation procedures and strategies to accelerate regulatory submissions & site activations

· Accountable and perform regular review of start-up performance and quality metrics at portfolio level and identify trends/gaps within the start-up processes, which may impact key deliverables (eg. timelines/ quality/costs)and work closely with internal stakeholders and/or external partners to ensure action or mitigation plans are defined and implemented at a program level

Experience:

• Applied knowledge of project management processes and skills
• 2-5 years’ experience in clinical development, with some experience in clinical research/ Involvement in cross-functional clinical trials/experience in supporting the operational activities of clinical trials.
• Appreciation of / experience in compliance-driven environment
• Effective communication, negotiation, and problem-solving skills and demonstrated ability to meet timelines.
• Self-management and organizational skills.