Clinical Data Management and Oversight Specialist
hace 3 días
Job Title: Clinical Data Management and Oversight Specialist
Are you passionate about data-driven insights and leadership? Do you have experience in clinical operations and a strong understanding of regulatory requirements? We're looking for a talented Clinical Data Management and Oversight Specialist to join our team
About the Role:
- Lead the Centralized Monitoring team in performing oversight on clinical deliverables for global assigned projects.
- Unblinded Clinical Lead for assigned studies, responsible for IP management and risk mitigation.
- May act as Clinical Lead when not assigned to a study or at project close-out.
- Manage project resources, including CRAs, Central Monitors, Clinical Trial Assistants, and Centralized Monitoring Assistants.
Responsibilities:
- Manage, monitor, and complete study/site metrics trending, including trend analysis and action plans.
- Contribute to developing the study-specific analytics strategy and advanced analytics.
- Support project management teams in developing monitoring strategies and triggers/thresholds.
- Attend study team and client meetings, providing inputs to clinical study teams, key decision-makers, and internal team members.
- Develop and use study management plans, RBM tools, and templates to evaluate quality and integrity.
- Mentor junior staff and ensure complete documentation of study-specific tools and templates.
Requirements:
- Bachelor's degree in life sciences or related field.
- Strong written and verbal communication skills, with advanced command of English.
- Strong organizational, problem-solving, and decision-making skills.
- Results-oriented approach to work delivery and output.
- Excellent motivational, influencing, negotiating, and coaching skills.
- Ability to work on multiple global projects and manage competing priorities.
- Cultural awareness and understanding, with ability to lead teams and work effectively across cultures.
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