Local Country Study Manager

ICON 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 centre 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.

We are hiring experienced Clinical Study Managers (Clinical Trial Managers, Project 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 Romania.

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 Romania. 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 (Romania).

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’ study management experience
• Experience in managing clinical studies in Romania
• 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

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, 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, 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.