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Clinical Data Governance Specialist
2 meses atrás
We are seeking a highly skilled Clinical Data Governance Specialist to join our team at ICON Plc.
About Us
ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment driving innovation and excellence, and we welcome you to be part of our mission to shape the future of clinical development.
Your Role
As a Clinical Data Governance Specialist, you will be responsible for effectively managing RBQM (Risk-Based Quality Management) activities across specific service lines, client projects, and staff. Your primary goal will be to ensure that all functions, projects, and tasks are handled with the highest quality, on time and within budget, in a manner consistent with SOPs, regulations, and ICON policies.
Key Responsibilities
- Recognize, exemplify, and adhere to ICON's values centered on Integrity, Inclusion, Agility, and Collaboration.
- Create a culture of quality in delivery and process improvement, focusing on optimizing and streamlining processes to add efficiency and value to our business while meeting client needs.
- Provide expert RBQM input into new business proposals, budgets, and bid defense meetings as applicable.
- Review protocols and provide expert input into risk identification and associated mitigation strategies.
- Review and assess existing Risk Management SOPs and components of other SOPs related to RBQM, supporting the development and review of new Risk Management SOPs, change management, process review, and design, as well as effective training, in line with ICON, regulatory, and industry requirements.
- Drive innovation and continuous improvement in all areas of responsibility, maintaining awareness of evolutions in technology, sponsor, and competitor positions, as well as regulations affecting RBQM, and lead/support working groups in initiatives for risk-based quality management or related process/system improvement.
- Analyze and provide input for business cases for development projects in Risk Management or cross-functional projects involving Risk Management.
- Liaise with sponsors and cross-functional team members on project or program-related matters where appropriate.
Requirements
To succeed in this role, you will need:
- A Bachelor's Degree in Science, Business, Medicine, or equivalent.
- Strength in risk management, communication, strategy, independent decision-making, negotiation, and conflict management.
- Client-facing experience.
- Experience leading a team.
- Knowledge of the clinical trial cycle.
- Subject matter expertise in RBQM.
- Comprehensive knowledge of ICH-GCP.
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.
We offer a competitive salary, estimated to be around $120,000 per year, based on market standards and your qualifications. Additionally, you can expect a range of benefits, including various annual leave entitlements, health insurance options, retirement planning offerings, global employee assistance programs, life assurance, and flexible country-specific optional benefits such as childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, and health assessments.
Why Work With Us?
We are committed to providing an inclusive and accessible environment for all candidates. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and communities. We pride ourselves on being a more inclusive organization and are dedicated to providing a workplace free of discrimination and harassment.
Join us in shaping the future of clinical development and become part of a dynamic team that values integrity, inclusion, agility, and collaboration.
