Clinical Operations Lead

Job Description

We are seeking a Clinical Operations Lead to oversee clinical trials and ensure compliance with regulatory standards. The successful candidate will manage project timelines, coordinate team activities, and liaise with internal and external stakeholders.

Responsibilities

• Lead the operational strategy for clinical research projects.
• Ensure data integrity and compliance with Good Clinical Practice (GCP).
• Collaborate with the regulatory affairs team to ensure timely submissions.
• Develop site selection criteria and perform feasibility assessments.
• Assist in the budgeting and forecasting for clinical projects.
• Review and approve trial documents prior to submission.
• Conduct training sessions for clinical staff.
• Establish effective lines of communication within the project team.
• Manage the day-to-day operations of clinical trials.
• Monitor and report on trial progress and outcomes.

Requirements

Education

• Bachelor's degree in Clinical Research or related field
• PhD is an advantage

Experience

• 7+ years of experience in clinical operations and management

Technical Skills

• Clinical Project Management
• Compliance Standards

Soft Skills

• Interpersonal Skills
• Strategic Thinking

Languages

• English: Fluent

Advantageous

• Experience with risk management: Understanding of risk assessment and management in clinical trials.
• Background in patient advocacy: Prior work involving patient engagement and advocacy is beneficial.

Benefits

• Generous annual leave policy
• Wellness programs including gym memberships
• Professional development and training opportunities
• Supportive team environment

Company Culture

• Growth Focus: We invest in our people, providing ample opportunities for training and professional growth.
• Impact Driven: Our work has a direct impact on the community, making a real difference in people's lives.
• Transparency: We promote transparency in our operations and encourage open communication across all levels.