Clinical Trial Manager

As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

We are currently recruiting for an experienced Clinical Trial Managers/ Local Study Leader to join our FSP team in Bulgaria.

This is a sponsor dedicated role in wich you will be assigned to a global biopharmaceutical company specialised in diabetes, obesity, and rare blood and endocrinology studies.

Responsibilities:

• Local trial management of clinical trials mainly in phase 2 and 3 from feasibility to trial closeout activities
• Responsible for deliverables and high-quality execution of clinical trials in Bulgaria
• Leading the local study teams (CRAs & CTAs)
• Planning, executing, coordinating tasks and communicating between relevant roles, such as CTA and CRAs,  affiliates and global trial management, to facilitate the progress of the trial
• Attending all trial related meetings / TCs and ensuring knowledge sharing across the trial team
• Proactive risk identification and executing mitigation plans at the local level
• Ensuring successful start-up of clinical activities
• Responsible for trial budgets on local level
• Execute and follow up on recruitment and retention plans
• Perform Visit Report review (all type of visits)
• Conduct co-monitoring visits
• CTMS set-up & update at country level 
• Oversight and compliance check of eTMF for assigned clinical trials in close collaboration with CTAs
• Audit readiness, audit action plans and follow up for assigned clinical trials
• Inspection readiness and inspection action plan

Requirement:

• BA/BS/BSc or RN, with Master level of education preferred
• Fluency in English – written and spoken
• Minimum 5 years of experience in operational aspects of planning and conducting clinical trials
• Minimum 1 year (preferably 2 years) of experience in local study management of clinical trials
• Project planning experience including oversight of study deliverables, budgets, and timelines
• Ability to apply scientific and clinical knowledge to clinical research
• Experience anticipating and resolving problems
• Experience writing and presenting clearly on scientific and clinical issues

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.

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