Clinical Data Standards Specialist
hace 3 días
About ICON Clinical
ICON Clinical is a world-leading healthcare intelligence and clinical research organization dedicated to shaping the future of clinical development. Our diverse and dynamic team fosters an inclusive environment driving innovation and excellence.
We are currently seeking a Principal Clinical Data Standards Consultant to join our team in EMEA. As a Clinical Data Standards Consultant at ICON Clinical, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
Responsibilities:
You will be responsible for developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards. You will collaborate with cross-functional teams to define data collection strategies and standards for clinical trials. Additionally, you will develop and maintain training and reference materials related to standards topics including CDASH, SDTM, Terminology, ADaM, define-XML, and regulatory submission requirements.
Your Profile:
To excel in this role, you should possess a Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science, or related discipline); advanced degrees are a plus. You should have extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry. Advanced proficiency in CDISC standards and relevant regulations (e.g., FDA, EMA) is required. Excellent analytical and problem-solving skills with a keen attention to detail are essential. Excellent communication and collaboration abilities to work effectively in cross-functional teams are also necessary.
What We Offer:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary of £80,000 - £100,000 per annum, depending on location, ICON Clinical offers a range of additional benefits focused on well-being and work-life balance opportunities for you and your family. These benefits include various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, a Global Employee Assistance Programme, and flexible country-specific optional benefits.
Culture and Values:
Diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organization. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON Clinical 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.
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