Ref #: 30072

Employment type: Permanent - Full-Time

Location: Poland

Posted: 09-Jul-2021

Description

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.
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.


Overview:
The role of Local Study Manager (LSM) is to lead Local Study Teams ( CRAs and CTAs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines aligning with Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
In addition to leading the project teams, the Local Study Manager may perform site monitoring as needed to support the flexible capacity model. LSM is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. This position can be home-based.

Key Responsibilities:
• Leads and optimises the performance of the Local Study Team(s) 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.
• You will works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions
• Ensures that all country and site level trial crucial 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 sponsor's SOPs.
• Oversees, leads 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
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Participates in training and coaching new members of the Local Study Team
• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
• Plans and leads activities associated with audits and regulatory inspections

Required experience and qualifications:
• BA/BS/BSc in the sciences or previous experience in a similar role
• Previous Lead CRA experience or clinical study management experience on a country level
• Minimum 3 years of experience in Development Operations (CRA, Sr CRA)
• Experience in oversight and management of local project teams
• Excellent project management skills.
• Team building and interpersonal skills.
• Excellent verbal and written communication skills.
• Excellent knowledge of spoken and written English.


Benefits of working in ICON
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.
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.

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