Study Start Up Associate II

As a Start Up Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

In this role you will work with the Senior Director, Study Start Up and the clinical trial teams to improve operational excellence and efficiency of clinical trial execution in study and site start up across all phases of Clinical Development activities.

What you will be doing:

• Support the Clinical Operation team in the successful execution of clinical trials, from protocol concept to Site Activation, complying with ICH / GCP / EMEA guidelines and regulations and SOPs
• Drive adherence to standards for planning and execution of study start up, country requirements, working in collaboration with Clinical Operations on site information management activities to ensure time critical and high-quality delivery of study specific needs
• Partnering with Clinical Operations and clinical trial team, ensure the real time collection of information that informs investigator site identification through activation, forecasting and planning and contributes to accurate site activation deliverables
• Engage and develop strong working relationships with clinical study teams (e.g., Clinical Operations, Clinical Supply, Legal and Regulatory) to generate the best outcomes for site start up activities
• Working closely with SSU Managers to develop and send Site Outreach messages, track site responses and completion of Confidentiality Disclosure Agreements and Feasibility Questionnaires.
• Ensure that selected sites are meeting or exceeding all site start up requirements leading to Site Activation.  This includes working to create Site Specific Activation Plans with investigator sites to drive to competitive Site Start Up Timelines.
• Utilize Veeva Vault Clinical – CTMS, TMF, SSU Module and Site Connect to capture, manage and archive Country, Site and Person contact information and milestones that enable direct communications with sites and required forecasting for Site Activation
• Utilize Veeva Vault Clinical Reports to ensure the completeness and accuracy of the Veeva Vault Clinical – CTMS/TMF/SSUm/SC datasets; assess the status of Site Activation related activities and determine if risks are surfacing and how to best mitigate the issues
• Collect and summarize data and study start up insights for Clinical Operations and clinical trial team’s consideration to improve Study Start Up turnaround times.
• Proactively identify and implement best site start up practices, seeking continuous process improvement

You are:

• Bachelor’s degree in a Scientific/Medical field; Minimum of 5+ experience
• Understanding of US and global regulations and guidelines (e.g., FDA, EMEA, ICH) applicable to clinical development
• Experience within the pharmaceutical industry or Clinical Research Organization (CRO) working with clinical development processes, specifically Site Start Up; Understanding of the complexities associated with study and site start up
• Strong analytical and project management skills
• Able to rapidly adapt to changes in the work environment, manage competing demands and change approach or method to achieve optimal fit-for-purpose solution
• Excellence in driving results. You persist in accomplishing objectives and exceeding goals despite obstacles and setbacks, while also helping others to achieve results
• Excellent verbal / written communication and collaboration skills and ability to influence and build effective relationships in a matrix organization, including to ensure timely follow-up, issue resolution, and report updates

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.