Principal Clinical Data Standards Consultant

This is a fully remote position, open to applicants in India.

📋 Description

• Deliver expert-level functional knowledge in at least one standards domain and create standards content for both internal and sponsor-facing projects.

• Establish, implement, and maintain ICON Data Collection standards libraries that comply with CDISC, sponsor, and regulatory requirements.

• Oversee standards implementation and ensure adherence across clinical data management activities.

• Propose and promote best practices to enhance processes, products, and services.

• Define data collection strategies and standards for clinical trials in collaboration with cross-functional teams.

• Engage in standards governance activities and provide expert insights on complex subjects.

• Lead or participate in departmental initiatives, potentially taking on the role of project lead and coordinating team efforts.

• Assist in the creation of training materials and reference documentation on CDASH and Controlled Terminology.

• Keep track of industry trends, regulatory updates, and emerging standards.

• Mentor and support junior team members.

• Develop and implement comprehensive data standards libraries from data collection through to analysis.

• Offer internal and external consulting on CDISC standards compliance and implementation.

• Aid sponsors in the development, implementation, maintenance, and governance of data standards content.

• Create and present training for internal teams and external sponsors.

• Assist in the development and maintenance of technologies used to implement data standards.

• Participate in standards governance team meetings and provide standards input.

• Guide others in addressing complex problems and uncover innovative solutions.

• Present and advocate for analyses and secure approval on intricate matters.

• Travel approximately 15% domestically and/or internationally.

⛳️ Requirements

• Expert functional knowledge in at least one standards area.

• Capability to apply expert knowledge of business challenges and suggest best practices.

• Experience in developing standards content for both internal and sponsor needs.

• Proficient in providing guidance on standards implementation and compliance.

• 12–15 years of relevant experience.

• An equivalent combination of education, training, and relevant experience may be accepted in lieu of the specified education and experience.

• Ability to lead others in resolving complex issues using advanced analytical thinking.

• Capability to exercise judgment and identify innovative solutions.

• Potential to significantly influence operational, project, or departmental objectives.

• Ability to ensure that quality standards are met.

• Ability to operate in alignment with business strategy.

• Ability to adjust communication style and utilize persuasion effectively.

• Proficient in presenting and advocating for analyses and securing approval on complex matters.

• Willingness to travel approximately 15% domestically and/or internationally.

• Legal authorization to work in the country where the role is based.

🏝️ Benefits

• A culture of continuous learning and opportunities for professional development.

• A comprehensive and competitive total rewards package.

• Attractive base salary.

• Variable pay and recognition programs.

• Medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.

• Supportive policies and wellness initiatives.

• Reasonable accommodations during the recruitment process.