Principal Clinical Data Standards Consultant
ICON plc · Bengaluru · onsite · Posted 42d ago
Not disclosed5–11 yrsfulltimeSourced from
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About this role
- Principal Clinical Data Standards ConsultantBengaluruOffice based
- ICON plc is a world-leading healthcare intelligence and clinical research organization
- Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development
- We are currently seeking a Principal Clinical Data Standards Consultant to join our diverse and dynamic team
- As a Clinical Data Standards Consultant at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of inNvative treatments and therapies
- What You Will Be Doing
- As a Senior Clinical Data Standards Consultant at ICON Plc, 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
- Your profile
- 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 biotechNlogy 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
Sourced from foundit
Skills
Problem Solvingclinical dataBiotechnologyData Management
About ICON Plc
ICON plc
Clinical Research
4.5k+
employees
1990
36 years old
Chennai, Tamil Nadu
India
About
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.
Industries
Clinical ResearchBiotech & Life sciencesPharma
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