Clinical Data Standards Expert
hace 1 día
We are seeking a skilled Clinical Data Standards Expert to join our team at Icon Clinical Plc. With a strong focus on innovation and excellence, we foster an inclusive environment that drives growth and development.
As a Clinical Data Standards Consultant, 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. Our dynamic team is committed to delivering high-quality results, and we welcome talented individuals who share our passion for clinical development.
This exciting opportunity offers a competitive salary of £80,000 - £100,000 per annum, depending on experience, plus a range of benefits that support your well-being and work-life balance.
You will be responsible for:
- 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.
To excel in this role, you should possess the following qualifications and attributes:
- 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 biotech 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.
In addition to your competitive salary, you can expect a range of benefits, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning, and more.
We are an equal opportunities employer and welcome applications from diverse candidates. If you need any reasonable accommodations during the application process, please let us know.
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