Join a Leading Pharmaceutical Company Driving Innovation in Hem-Onc Therapies

Position: Senior Clinical Trial/Operations Manager (CTM)

Contract: 6 Months Renewable (40 hours per week) - Projects will be ongoing for years to come.

Location: Hybrid

Are you an experienced Clinical Trial/Operations Manager ready to make an impact in advancing oncology therapies? We are looking for a driven professional to lead and manage Hematology/Oncology clinical studies, ensuring exceptional performance and adherence to industry standards.

Key Responsibilities

• Audit & Inspection Preparation: Support Clinical Operations in achieving inspection and audit readiness.
• Vendor Oversight & Third Party Management: Manage and oversee CROs and other external vendors to ensure quality deliverables and adherence to study timelines and budgets. Evaluate vendor performance and address any gaps or concerns proactively.
• Running Trials: Lead the day-to-day operations of clinical trials from start-up to close-out, ensuring seamless execution across all phases. Monitor study progress, identify challenges, and implement solutions to meet milestones.
• Work with Cross-Functional Teams: Collaborate with clinical, regulatory, medical, and biostatistics teams to align operational strategies with overarching project goals. Provide input on protocol development and operational feasibility assessments.
• Team Coordination: Collaborate with project teams and stakeholders to ensure smooth and efficient execution.
• Leadership: Drive clinical operations and cross-functional teams through the planning, execution, and reporting stages of clinical trials.
• Problem Solving: Proactively identify and address study-related challenges to maintain data quality and meet milestones.
• Recruitment Management: Monitor and optimize site-level recruitment to achieve enrollment targets.
• Project Oversight: Leverage project management tools to efficiently manage study timelines and budgets.

Qualifications

• Experience: Minimum 5 years managing clinical studies from initiation to completion; remote and on-site monitoring experience preferred.
• Experience: Managing Global Phase 3 Trials from initiation to completion.
• Expertise: Hematology/Oncology experience is a must.
• Education: Bachelor's degree or equivalent experience in Life Sciences.
• Knowledge: In-depth understanding of ICH/GCP guidelines and FDA regulations.
• Flexibility: Ability and willingness to travel as required.

Ready to Make a Difference?

If this opportunity aligns with your expertise and passion for driving clinical excellence, we’d love to hear from you! Apply below or send your updated CV directly to me at the contact information provided.

Contact:

Jean-David Mandarin

Clinical Associate Recruiter