Senior Clinical Trial Manager (Lupus)

About the role

The Senior Clinical Trial Manager (Sr. CTM) will lead the operational planning, execution, and oversight of complex, global clinical studies in the field of immunology and autoimmune diseases. This role is responsible for ensuring studies are delivered on time, within scope, and in compliance with regulatory standards, Good Clinical Practice (GCP), and company Standard Operating Procedures (SOPs).

Responsibilities

• Lead the operational strategy, planning, and execution of global Phase 1–4 clinical trials in immunology indications (e.g., autoimmune and inflammatory diseases).
• Serve as the primary operational point of contact for internal stakeholders and external partners.
• Oversee the selection and management of CROs and other vendors, including scope of work, budget development, contracting, and performance oversight.
• Drive site feasibility, site selection, activation, patient recruitment strategies, and ongoing site management to ensure achievement of enrollment goals.
• Develop and maintain study timelines, risk mitigation strategies, and operational tracking tools.
• Collaborate with cross-functional teams on protocol development, CRF design, ICF review, and development of operational study plans.
• Ensure studies are conducted in compliance with GCP/ICH guidelines, local regulatory requirements, and internal SOPs.
• Proactively identify and resolve operational issues, escalating risks and implementing mitigation strategies as needed.
• Oversee data collection activities, database lock readiness, and support data review processes.
• Contribute to regulatory filings, inspection readiness, and audit preparation.
• Provide leadership and mentorship to Clinical Operations team members.
• Contribute to process improvement initiatives within Clinical Operations to enhance efficiency and quality.
• Perform other duties and responsibilities as assigned

Qualifications

• Education: Bachelor’s degree in life sciences or related field (advanced degree preferred)
• Minimum 5 years of experience in clinical operations in the biopharmaceutical industry, with at least 3 years in a Senior CTM or equivalent leadership role.
• Proven track record of managing global, multi-center clinical trials in immunology or autoimmune disease indications.
• Experience with biologics, monoclonal antibodies, or advanced therapies.
• Strong knowledge of GCP/ICH guidelines, clinical trial regulations, and operational best practices.
• Experience in rare autoimmune indications or immune-mediated inflammatory diseases.
• Familiarity with adaptive trial designs or complex biomarker-driven studies.
• Experience in early- to late-stage development programs, including pivotal trials.
• Proficiency with electronic systems such as CTMS, EDC, eTMF, and risk-based monitoring tools.
• Ability to thrive in a fast-paced, dynamic environment and work independently with minimal supervision
• Excellent communication, leadership, and problem-solving skills.