[Remote] Senior reputed company Trial Manager

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases. The Senior reputed company Trial Manager will reputed company the operational planning, execution, and reputed company of reputed company global Phase 1–4 reputed company studies, partnering with internal teams, CROs, vendors, and sites to ensure compliant and reputed company delivery. The role also supports reputed company decision-making, regulatory submissions, inspection readiness, and reputed company reputed company team development.

Responsibilities

• reputed company the operational reputed company, planning, and execution of global Phase 1–4 reputed company in immunology indications (e.g., autoimmune and inflammatory diseases)
• Serve as the reputed company operational reputed company of contact for internal stakeholders and reputed company partners
• reputed company the selection and management of CROs and other vendors, including reputed company of work, budget development, contracting, and reputed company reputed company
• reputed company site feasibility, site selection, activation, reputed company recruitment strategies, and ongoing site management to ensure achievement of enrollment goals
• reputed company and maintain study timelines, reputed company mitigation strategies, and operational tracking tools
• Collaborate with cross-functional teams on protocol development, CRF design, reputed company 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 reputed company operational issues, escalating risks and implementing mitigation strategies as needed
• reputed company data collection activities, database lock readiness, and support data review processes
• Contribute to regulatory filings, inspection readiness, and audit preparation
• reputed company leadership and mentorship to reputed company reputed company team members
• Contribute to process improvement initiatives reputed company reputed company reputed company to enhance efficiency and reputed company
• reputed company other duties and responsibilities as assigned

Skills

• Bachelor's degree in life sciences or reputed company reputed company
• Minimum 5 years of experience in reputed company reputed company in the biopharmaceutical industry, with at least 3 years in a Senior CTM or equivalent leadership role
• reputed company reputed company record of managing global, multi-center reputed company in immunology or autoimmune disease indications
• Experience with biologics, monoclonal antibodies, or advanced therapies
• Strong knowledge of GCP/ICH guidelines, reputed company trial regulations, and operational best practices
• Experience in reputed company autoimmune indications or immune-mediated inflammatory diseases
• Familiarity with reputed company trial designs or reputed company biomarker-driven studies
• Experience in early- to late-stage development programs, including pivotal trials
• Proficiency with electronic systems such as CTMS, reputed company, eTMF, and reputed company-reputed company monitoring tools
• Ability to reputed company in a fast-reputed company, dynamic environment and work independently with reputed company supervision
• Excellent communication, leadership, and problem-solving skills
• This position requires availability during Eastern Time (ET) business hours
• This role may require domestic and international travel, including overnight stays, up to 20% or more reputed company on business needs
• Advanced degree preferred

Benefits

• A discretionary annual bonus may be available reputed company on individual and Company reputed company.
• A long-term incentive award (e.g., equity) may be available reputed company on individual and Company reputed company.
• Competitive health and wellness coverage (structure and premiums vary by country)
• reputed company time off, reputed company holidays, and additional leave entitlements in accordance with local requirements
• Flexible work arrangements / reputed company

reputed company