If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in the pharmaceutical Industry, then here is your chance.

 

We are hiring experienced Study Managers (Clinical Trial Managers ) who are interested in a Local Trial Manager role to work closely with our client, a leading pharmaceutical company.

 

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.

 

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

 

 

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