The Senior Trial Manager will provide strategic leadership and operational oversight for clinical trials, ensuring studies are delivered successfully from planning through completion.
Compensation
Competitive annual base salary: Starting at $150,000 USD, with final compensation determined by qualifications, experience, skills, and competencies.
Responsibilities
Lead and oversee the planning, execution, and completion of clinical trials, ensuring compliance with applicable regulations, guidelines, and ICH/GCP standards.
Coordinate and manage clinical trial operations teams, ensuring effective collaboration, milestone achievement, and successful project delivery.
Oversee the development, review, and maintenance of essential clinical trial documentation, including Case Report Forms (CRFs), source documents, templates, and study plans.
Contribute to protocol and study design reviews, informed consent documentation, and provide operational guidance to Clinical Research Associates (CRAs) and investigative sites.
Develop and maintain study-specific Clinical Monitoring Plans (CMPs), incorporating clear communication, escalation procedures, and appropriate follow-up actions.
Requirements
Bachelor's degree or international equivalent from an accredited institution, preferably in clinical, biological, scientific, or healthcare-related disciplines, or an equivalent combination of education, training, and experience
Global Study Manager/Lead responsible for end-to-end clinical study delivery across multiple regions.
Responsibilities
Accountable for operational delivery of clinical study/studies to time, quality, and budget
Generate robust delivery plans and deliver to target thresholds
Lead study team to achieve deliverables
Prepare Study Initiation Meeting, Clinical Study Activity Plan, Study Delivery Plan, TMF Quality Strategy Document, DCT Set Up, Vendor Oversight Plan, Investigator/CRA Meeting Set Up and training, Recruitment Tracking, Budget tracking, eTMF filing, Vendor Set Up and Management, Safety Management plan
Identify, oversee, and mitigate study risks
Requirements
Bachelor’s degree in life sciences or related discipline
The role involves ensuring the accuracy, compliance, and timely approval of informed consent forms (ICF) for clinical trials, contributing to the ethical conduct of clinical research.
Compensation
Competitive base salary and performance related incentives
Responsibilities
Developing and reviewing ICFs: Preparing, reviewing, and approving Subject Information Sheets (SIS) and Informed Consent Forms (ICF) for global master templates, country-specific versions, and site-specific adaptations.
Ensuring compliance: Applying proficient knowledge of ICON SOPs/WPs, ICH/GCP guidelines, and applicable country regulations related to Informed Consent requirements.
Stakeholder collaboration: Serving as a key point of contact for Sponsors, SSU Project Managers, Clinical Trial Managers, and other functional leads to optimize performance and ensure successful project outcomes.
Query resolution: Proficiently reviewing, negotiating, and approving all Ethics Committee (EC), Institutional Review Board (IRB), and Competent Authority (CA) queries related to country and site-specific ICFs.
Timeline management: Forecasting and tracking SIS & ICF approval timelines, proactively identifying risks, and developing contingency plans to mitigate potential impacts.
Requirements
Nice to have: Protocol interpreting & review
Skills
Nice to have: Therapeutic experience in rare dermatology
Nice to have: Therapeutic experience in immunology
Nice to have: Therapeutic experience in inflammation
Nice to have: Therapeutic experience in autoimmune disease
Senior Trial Manager - FSNewJobgether · Remote, US