Ref #: 33961

Employment type: Permanent - Full-Time

Location: Ukraine

Posted: 10-Dec-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.


Due to continued growth, we are looking for an experienced Lead CRA or a Local Study Manager/ Clinical Lead to work as a Local Trial Manager for a global pharma company in Kiev. In this role you will manage and coordinate the conduct of international clinical trials in Ukraine.

We offer a full time permanent contract of employment and you will be fully dedicated to one sponsor.
The role is based in Kiev area.


Overview:

In this role you will act as 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 (local) level. You will maintain the quality and scientific integrity of clinical trials at a country level



Responsibilities:

Acts as primary local/country contact for a trial.
Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.
Leads and coordinates local trial team activities (CRAs and CTAs)
Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget.
Reviews and approves Monitoring Visit Reports submitted by CRAs;
Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered within budget.
Implements any local criteria for site selection and recommends suitable sites for selection to participate in trial.
Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
Maintains and updates trial management systems (e.g. CTMS, eTMF/LAF, Trial Master Source and Sharepoints).
Reviews and approves site and local vendor invoices as required
Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.


Requirements:

A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
Study management experience ( LeadCRA or Study/Trial Manager)
Should have solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
Solid communication and computer skills required.
Proficient in speaking and writing the country language and English language.
Good written and oral communication skill


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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