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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 currently recruiting for a Local Study Manager (Local Trial Manager) in Hungary to work on a range of therapeutic areas for a global biopharmaceutical company.
This particular role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development. This is a hybrid role so employee is required to visit the Bucharest office periodically, with flexibility to work remotely.
The Local Study Manager (LSM) will be responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
Responsibilities:
- LSM has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
- You will lead the Local Study Team consisting of CRAs, CTAs for assigned studies in Hungary.
- LSM leads and optimises the performance of the Local Study Teams at country level
- Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
- Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
- Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations
- Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs.
- Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
- Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
- Reviews monitoring visit reports and pro-actively advices the monitor(s) on study related matters.
- Performs any required co-monitoring, Accompanied Site Visits/training visits with CRAs.
- Reports study progress/update to the Global Study Leader/ Global Study Team
- Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
- Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
- Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
- Participates in training and coaching new members of the Local Study Team
- Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF “Inspection Ready”.
- Plans and leads activities associated with audits and regulatory inspections
Requirements:
- Bachelors degree in related discipline, preferably in life science, or equivalent qualification.
- Minimum 4 years of experience in Development Operations (CRA, Sr CRA)
- Previous experience in a similar role
- Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
- Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
- Excellent project management skills.
- Excellent team building and interpersonal skills.
- Excellent organisational skills.
- Excellent verbal and written communication skills.
- Excellent ability to prioritize and handle multiple tasks.
- Excellent knowledge of spoken and written English.
- Ability to travel nationally and internationally as required.
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.
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