Clinical Trial Manager

Role Summary

The Clinical Trial Manager will play a pivotal role in the strategic implementation and execution of clinical trials from study start-up to close-out. This individual will manage and oversee CROs, study vendors, and clinical trial sites, partnering with internal stakeholders to ensure deliverables are completed on time, within budget, and in accordance with regulatory requirements, GCP guidelines, and internal SOPs. This role supports trial strategy development and operational delivery within a fast-paced biotech environment.

Responsibilities

• Lead the successful execution of clinical trials from protocol concept to clinical study reports in support of complex oncology programs.
• Ensure inspection readiness by maintaining comprehensive study documentation and files.
• Organize and lead study and departmental meetings, including minute-taking and document archiving.
• Coordinate clinical trial equipment, supplies, and cross-functional project activities (e.g., Clinical Data Review Meetings).
• Ensure team compliance with study-specific training and perform TMF reviews for completeness.
• Support clinical sites in audit and inspection preparation.
• Assist with budget management and daily clinical operations, ensuring adherence to SOPs, ICH/GCP, and regulatory requirements.
• Monitor subject and site activity/metrics and perform quality checks across study components.
• Proactively identify, troubleshoot, and escalate issues impacting deliverables.
• Contribute to study set-up activities including protocol/synopsis development, informed consent forms, system configuration (CTMS, IRT), regulatory submissions, and operational documentation.
• Collaborate with CROs to ensure timely collection and archiving of TMF documents.
• Partner with regulatory affairs on essential document submissions.
• Support study close-out activities including TMF and drug reconciliation and CSR readiness.
• Foster effective communication and collaboration with study team members, Clinical Trial Managers, and Asset Leads.
• Participate in process improvement and quality initiatives related to study execution.
• Other duties as deemed necessary.

Qualifications

• Bachelor's degree with at least 5 years of hands-on clinical trial experience, within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered.
• Demonstrated experience in oncology trials, including trial set-up, monitoring, and close-out.
• Global clinical trial management experience, especially in the EU, highly desirable.
• Strong working knowledge of ICH/GCP regulations.
• Proficiency with electronic systems such as eTMF, CTMS, EDC, etc.
• Ability to work independently and thrive in a collaborative team environment.
• Strong critical thinking skills, a sense of urgency, and a proactive problem-solving mindset.
• Excellent interpersonal, written, and verbal communication skills.
• Proficiency in MS Office and comfort with technology.
• Minimal travel required (0 to 5%).