Director, Clinical Affairs - Remote

Overview

The Director, Clinical Affairs will play a critical role in supporting the CRO leadership team with business planning and execution of CRO engagements, overseeing clinical trials and ensuring compliance with regulatory requirements.

In Short

• Collaborate with senior leadership to develop objectives and staffing requirements.
• Ensure clinical trial projects are managed within budget and timelines.
• Implement productivity improvement techniques.
• Direct training programs and departmental systems development.
• Collaborate on vendor selection and oversight.
• Review project documents for compliance with SOPs and GCP.
• Lead project teams to meet deliverables.
• Maintain relationships with clients and project personnel.
• Assist with professional development for team members.
• Represent MCRA at conferences and meetings.

Requirements

• Bachelor’s degree in life sciences or related field.
• 10+ years of experience in clinical trials.
• 5+ years of medical device clinical trial experience.
• Expert knowledge of decentralized trials and clinical project management.
• Ability to manage multiple studies simultaneously.
• Experience with EDC and clinical trial management systems.
• Excellent communication and organizational skills.
• Experience working with senior management.
• Ability to adapt to a changing environment.
• Advanced proficiency in MS Office Suite.

Benefits

• Opportunity to work with a leading medical device advisory firm.
• Engagement in diverse clinical projects.
• Professional development opportunities.
• Collaboration with a multi-functional team.
• Exposure to global operations.