Lead Clinical Data Standards Specialist
Há 2 dias
Job Summary:
We are seeking a Clinical Trials Data Management Expert to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization.
About the Role:
This is an exciting opportunity to design and analyze clinical trials, interpret complex medical data, and contribute to the advancement of innovative treatments and therapies.
Key Responsibilities:
- Developing tools to aid in the implementation and compliance of CDISC, Sponsor, and ICON standards.
- Collaborating with cross-functional teams to define data collection strategies and standards for clinical trials.
- Developing and maintaining training and reference materials related to standards topics including CDASH, SDTM, TermiNlogy, ADaM, define-XML, and regulatory submission requirements.
- Managing the development and maintenance of data management processes and tools.
- Keeping abreast of industry trends and regulatory updates related to data standards and ensuring their integration into ICON's practices.
Your Profile:
- A Bachelor's degree in a relevant field (e.g., Life Sciences, Computer Science, or related discipline); advanced degrees are a plus.
- Extensive experience in clinical data management and standards within the pharmaceutical or biotechnology industry.
- Advanced proficiency in CDISC (Clinical Data Interchange Standards Consortium) standards and relevant regulations (e.g., FDA, EMA).
- Excellent analytical and problem-solving skills with a keen attention to detail.
- Excellent communication and collaboration abilities to work effectively in cross-functional teams.
What We Offer:
- A competitive salary range of $90,000 - $120,000 per year, depending on experience.
- A range of benefits, including annual leave entitlements, health insurance, retirement planning, and flexible country-specific optional benefits.
- A global Employee Assistance Programme, TELUS Health, offering 24-hour access to a network of professionals who support well-being.
- A commitment to diversity, inclusion & belonging, fostering a culture that rewards high performance and nurtures talent.
How to Apply:
Please visit our careers site for more information and to submit your application.
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