Senior CTA

Company: ICON Strategic Solutions
Location: Lincoln
Posted on: January 25, 2023

Job 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.

The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy, planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.

+ Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the CTA Manager.

+ Collaborate with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating mode

+ Perform departmental tasks as needed.

+ Perform developmental tasks as appropriate with oversight of CTA Manager

+ For assigned complex, accelerated, and/or business critical studies, provide support to focus on study start-up and site initiation activities, including but not limited to:

+ Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms, etc.

+ Supporting oversight of risk-based monitoring

+ Attendance of key team meetings as required.

+ Supporting regulatory inspection readiness (e.g. preparation of materials and/or participation during regulatory inspections.)

+ Support Clinical Trial systems associated activities for assigned studies

+ Support Vendor Contract Administration

+ Support study close-out activities

+ Requires strong attention to detail in composing and/or proofreading and/or approving study materials, establishing priorities, scheduling, and meeting deadlines.

+ Ability to take ownership and manage tasks, as well as communicate effectively

+ Assigned clinical studies may be high complexity and/or high risk.

+ More than one study and/or more than one program may be assigne

+ Interactions with study teams and other colleagues are both local and remote (in varying locations and timezones).

Bachelor's degree or equivalent international degree required.

+ 2-4 years' experience in pharmaceutical industry, clinical research organization, or related role.

+ Experience in Phase 2 and 3 studies and global/international studies is advantageous.

+ Experience working across multiple therapeutic areas (including oncology) is advantageous.

+ Knowledge in global/regional regulatory and compliance requirements for clinical research.

+ Demonstrated excellence in task management and cross-functional collaboration.

+ Excellent communication skills.

+ Excellent teamwork, organizational, interpersonal, and problem-solving skills.

Fluent business English (oral and written

**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.

Keywords: ICON Strategic Solutions, Lincoln , Senior CTA, Other , Lincoln, Nebraska