Ref #: 29408

Employment type: Permanent - Full-Time

Location: Sydney

Posted: 24-May-2021

Description

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.
Overview
The key duties of the Country Study Manager is to act as 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 accordance with ICH-GCP and applicable local regulations. You will be required to maintain the quality and scientific integrity of clinical trials at a country level. You will be required to actively collaborate 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 region
• Ensure relevant systems are updated to enable accurate reporting of study progress and milestone deliverables
• Ensure key stakeholders are kept informed of study progress e.g. GCTM, DOM
• Contribute to development of study-specific materials – e.g. monitoring plan, study specific training documents.
• Provides input into the Country Operational Plan (COP) and partner with the DFM and GCTM to ensure regional delivery of the Global Study Operational Plan (GSOP)
• Support and contribute to Trial Management Teams (TMTs), agenda driven presence at meetings and daily huddle as required
• Communicate country status (including timelines and deliverables) to key stakeholders (e.g. TMT, GCTM, Program Managers) and ensures updates to relevant systems
• Contributes to site-level goal setting and study-specific deliverables for clinical sites within their country

Required experience and qualifications
• Doctorate degree OR
• Master’s degree & 3 years of directly related experience
• Bachelor’s degree & 5 years of directly related experience
• Associate’s degree & 10 years of directly related experience
• High school diploma / GED & 12 years of directly related experience


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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