Open Positions at ICON plc

Responsibilities:

• Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
• Work collaboratively with investigative sites to develop strong, long-term, working relationships.
• Apply SOPs, Clinical Monitoring Plan (CMP), study manuals and other materials and guidelines as applicable.
• Help identify and qualify potential investigators.
• Perform all type of visits from Pre-Study to Close out.
• Provide initial and ongoing training to site personnel regarding the study protocol, applicable policies/procedures, and GCP.
• Assist with start-up activities, including essential document review and collection as requested.
• Lead and drive regulatory Ethics Committee submission and site start-up activities in partnership with investigator sites including the support of EC follow up queries and responses as required.   
• Liaise with sites to support contracts/budget negotiation and support the development and adaptation of country/site specific informed consent forms under the direction of the internal team.

To enable success in this position you will have:

• Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment.
• A minimum of 3 years of on-site independent monitoring experience is required in medium-sized studies, including study start-up and close-out.
• You will be educated to degree level, within an applicable field.
• Excellent written and verbal communication
• Ability to work to tight deadlines.
• Availability to travel least 60% of the time and should possess a valid driving license
• A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential.
• Ideally having gained expertise in multi-therapeutic areas.
• Must be based in Gauteng, South Africa

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The Role:

• As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.
• Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
• Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager – Central Services or Designee.

What you need

• Bachelor’s Degree preferably in Life Sciences
• Minimum of 3 years’ experience or understanding of clinical study start up requirements and activities.
• Experience of Clinical Trial operations and meeting regulatory guidelines
• Proficient project management skills.

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The role

• You will lead/project manage multi-disciplinary teams on assigned projects.
• Be responsible for developing, maintaining and validating standard data structure and software.
• Design and write standard departmental macros that are maintainable, supportable, well-documented programs which are user friendly and accessible.
• Monitor procedures for program development and validation and assist in the training of statisticians/programmers to ensure the development of data analysis skills.

What you need

• Bachelor’s degree in a quantitative or scientific discipline or equivalent, with Master’s degree or PhD preferred.
• Recent experience must be relevant and have primarily been involved in creating and validating analysis datasets (CDISC ADaM standard preferred), Tables, Listings and Graphs.
• Knowledge of a wide variety of technologies.
• Professional leadership skills coupled with exceptional communication skills.