Lead Clinical Research Associate (CRA / CTM)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

ICON Romania are currently recruiting for experienced Senior CRAs who are willing to take a step up in their career and take some local CTMs activities. . The sucessful candidate will work on a hybrid role of a SrCRA & Clinical Trial Manager (50/50) for a global pharmaceutical company with their officies in Bucharest.

This particular role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs.

Responsibilities:

• Responsible for the leadership of their assigned CRAs on a given study(s), driving the team to ensure study deliverables are met with efficiency and quality
• Responsible for training the CRAs on the study and ensuring study training compliance is maintained
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports and metrics, including protocol deviations and follow-up items, to evaluate for compliance and trends, summarizing for the study team, escalating issues, and involved in the development of corrective and preventative actions, as needed
• Responsible for ensuring CRAs maintain their sites as inspection ready, including the Trial Master File (TMF), for health authority inspections at all times
• Conducts  co-monitoring visits and other on-site monitoring visits (pre-study visits, site initiation visit, interim monitoring visit, or close-out visit) as required by study needs
• Reports study progress/update to the Country Head/ Global Study Team
• Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
• Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
• Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF “Inspection Ready”.
• Plans and leads activities associated with audits and regulatory inspections 

Requirements:

• Bachelors degree in related discipline, preferably in life science, or equivalent qualification.
• Minimum 5 years of experience in Development Operations (Sr CRA)
• Previous experience in study management/ CTM/LeadCRA related tasks. 
• Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
• Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
• Project management skills.
• Excellent team building and interpersonal skills.
• Excellent verbal and written communication skills.
• Excellent ability to prioritize and handle multiple tasks.
• Excellent knowledge of spoken and written English.

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/benefitsICON, 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, colour, 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 or submit a requesthere.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.

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