Clinical Trial Manager/Senior Clinical Trial Manager

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Support the successful execution of clinical trials from protocol concept to clinical study report in support of complex autoimmune programs.
• Prepare and maintain study-related files and documentation to ensure inspection readiness.
• 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 preparation for audits and inspections.
• Assist with budget management and day-to-day clinical operations in compliance with SOPs, ICH/GCP, and regulatory requirements.
• Track subject and site activity/metrics and perform quality checks across study components.
• Proactively identify and escalate issues related to functional 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.
• Coordinate with regulatory affairs on essential document submissions.
• Support study close-out activities including TMF and drug reconciliation and CSR readiness.
• Communicate effectively with study team members and work closely with Clinical Trial Managers and/or Asset Leads.
• Participate in process improvement and quality initiatives related to study execution.
• Other duties as deemed necessary.

REQUIRED EDUCATION, EXPERIENCE, SKILLS, AND ABILITIES

• Bachelor’s degree with at least 5 years (CTM) or 8 years (Sr. CTM) of hands-on clinical trial experience, preferably within a pharmaceutical or biotech environment. A combination of CRO and sponsor-side experience will be considered.
• Demonstrated experience in complex autoimmune clinical trials, including trial set-up, monitoring, and close-out.
• Strong working knowledge of ICH/GCP regulations.
• Proficiency with electronic systems such as eTMF, CTMS, EDC, etc.
• Ability to work independently with minimal oversight 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%).