Local Trial Manager

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

We are hiring experienced Clinical Study Managers (Clinical Trial Managers, Study Leaders ) who are interested to work closely with our client, a leading pharmaceutical company. They focus on such therapeutic areas as: cardiovascular disease, oncology, bone health, neuroscience, nephrology and inflammation. In this role will be responsible for project managment of clinical trials in Bulgaria.

Overview of the role:

In this role you will be a primary point of contact to lead, manage and co-ordinate the conduct of clinical trials from study start-up to close out at a country level in Bulgaria. You will maintain the quality and scientific integrity of clinical trials at a country level.  Trial Manager collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables within the country (Bulgaria).

Key responsibilities:

• Planning, management and oversight of clinical study execution in accordance with the global program strategy, through leadership of the cross-functional Local Study Team (LST)

• Accountable for study deliverables in that country.

• Leads country-level operational planning and supports site selection within assigned country(ies)

• Ensure key stakeholders are kept informed of study progress e.g. GCTM, DOM

• Communicate country status (including timelines and deliverables) to key stakeholders (e.g. TMT, GCTM, Program Managers) and ensures updates to relevant systems

• Contribute to, deliver and/or lead CRA, Investigator and Study Coordinator training

• Oversight and monitoring of applicable vendor activities eg. laboratories and equipment provisioning

• Monitor the execution of the clinical study against timelines, deliverables and budget for that country

• Review Monitoring Visit Reports

• Contribute to the study-level forecast for investigational product, support study level accountability and reconciliation across assigned countries, management of ELE process

• Execute regulatory agency inspection readiness activities (e.g. TMF review, story board generation)

• Assign and oversee deliverables of study support staff e.g. Study Management Associate, CTS

• Collaborating with local teams to ensure country level study delivery is aligned with global expectations

To be successful in the role, you will have:

• BA/BS/BSc degree
• Minimum 1- 3 years’ local/regional study management experience
• Experience in managing clinical studies in Bulgaria
• 5 years work experience in life sciences or medically related field, including 4 years of biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company
• Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
• Previous CRA experience

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, inclusion & belonging are fundamental to our culture and values. 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, 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 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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