Compliance Specialist I

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.


JOB FUNCTIONS/RESPONSIBILITIES -

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.*
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.*
• Perform Quality Management Reviews (QMRs) of low to medium complexity on active projects as assigned*
• Ensure projects adhere to the System Development Life Cycle (SDLC) and/or applicable processes*
• Identify gaps and inconsistencies in data and make rational judgements from available information and analysis*
• Communicate with department management and project regarding quality and/or compliance issues and trends*
• Make independent judgments as the subject matter expert in order to complete compliance specialized tasks/requests*
• Provide critical input for proactive resolutions and improvements related to role*
• Communicate with internal and external clients on compliance related matters*
• Maintain confidentiality of project information as appropriate*
• Train and mentor team members as assigned

EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS-

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to perform all assigned tasks with moderate supervision and review
• Ability to manage multiple tasks and timelines with moderate supervision
• Ability to liaise professionally with internal and external clients
• Ability to work in a team environment and resolve conflict
• Knowledge of clinical trials is preferred
• Possess strong verbal and written communication skills
• Ability to write accurate and efficient SQL queries with level ranging from low to medium complexity
• EU/APAC - prior relevant experience in a quality compliance or quality assurance role preferred. Alternatively prior experience in clinical research

US/LATAM/CAN - minimum of 1 year of quality compliance or quality assurance experience preferred. Alternatively 1 year prior experience in clinical research

Location Options

• Chennai

Benefits of Working in ICON:
Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON 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 through the form below.