As a Clinical Trial Manager you will be dedicated to one of our global pharmaceutical clients; with whom ICON shares a culture of innovation, flexibility and a common vision of bringing life-improving drugs to market. Leading by example, you can set the standard of excellence and enjoy a challenging career in our exclusive programs.

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. Local Trial Manager collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables within the country.

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