Ref #: 27756

Employment type: Permanent - Full-Time

Location: Bulgaria

Posted: 02-Apr-2021

Description

ICON FSP are looking to recruit a Lead CRA/ Principal CRA who would be interested in taking a step up in his/her career as a Clinical Trial Manager and work closely with our client, a leading pharmaceutical company.
We offer a full time permanent contract of employment and you will be fully dedicated to one sponsor.

Overview
As a Local Trial Manager you will be responsible for study management on country level, leading the local team (e.g. CRA, CTA, etc.) to ensure delivery of country and site level study activities in alignment with the global study project plan, review and approval of visit reports, manage the trial submission to IEC/HA, planning and budgeting of clinical trial, etc

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 (Local/ Country Study 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


About DOCS:

ICON FSP provides global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical trial industry.


Key words:
LTM, Local Trial Manager, Study Manager, CTM, Clinical Trial Manager, Project Management, Study Conduct, Regulatory, Pharmaceutical, CRO, Pharma, Contract Research Organisation, Biotech, Medical Device, Health, Biotechnology, Chemistry, Permanent, Sofia, Bulgaria


Why join the DOCS team at ICON?

Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.

It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.

At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.



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