Clinical Trial Manager Position Overview
We are seeking an experienced and detail-oriented Clinical Trial Manager (CTM) with expertise in oncology early-phase (FIH, Phase 1/1b) studies to oversee the planning, execution, and management of clinical research studies. The CTM will serve as the primary point of contact for internal teams, investigators, and vendors to ensure clinical trials are conducted in compliance with regulatory requirements, study protocols, and organizational goals. This role is critical to ensuring patient safety, data integrity, and timely delivery of high-quality clinical outcomes in a lean, fast-paced biotech environment.
Key Responsibilities
• Lead the planning, initiation, execution, and closeout of early-phase oncology clinical trials, including dose-escalation and expansion cohorts.
• Develop study timelines, budgets, and resource plans; track progress against milestones.
• Ensure compliance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines , including Project Optimus and evolving oncology regulatory expectations.
• Manage relationships with CROs, vendors, and study sites, including contract negotiations and performance oversight
• Collaborate with cross-functional teams (clinical operations, medical, regulatory, data management, biostatistics, and pharmacovigilance).
• Oversee trial master file (TMF) documentation to ensure inspection readiness at all times.
• Support site selection, qualification, initiation, monitoring, and closeout activities.
• Provide leadership, training, and mentorship to clinical operations team members.
• Identify and proactively resolve study-related risks, issues, and deviations
• Prepare and present study updates to internal stakeholders and senior leadership.
Qualifications
• Bachelor’s degree in life sciences, or related field (advanced degree preferred).
• 5+ years of experience in oncology clinical research, with at least 2 years in a trial management or project management role.
• Strong understanding of clinical trial regulations, GCP guidelines, and industry best practices.
• Proven ability to manage multiple projects simultaneously in a fast-paced environment.
• Excellent organizational, leadership, and problem-solving skills.
• Strong communication and interpersonal skills for collaboration with investigators, vendors, and cross-functional teams.
• Proficiency with clinical trial management systems (CTMS), electronic data capture (EDC), and Microsoft Office Suite.
• Work hour flexibility to ensure communications with colleagues in different time zones
• Hybrid position (2+ days on-site)
Clinical Trial Manager Position Overview
We are seeking an experienced and detail-oriented Clinical Trial Manager (CTM) with expertise in oncology early-phase (FIH, Phase 1/1b) studies to oversee the planning, execution, and management of clinical research studies. The CTM will serve as the primary point of contact for internal teams, investigators, and vendors to ensure clinical trials are conducted in compliance with regulatory requirements, study protocols, and organizational goals. This role is critical to ensuring patient safety, data integrity, and timely delivery of high-quality clinical outcomes in a lean, fast-paced biotech environment.
Key Responsibilities
• Lead the planning, initiation, execution, and closeout of early-phase oncology clinical trials, including dose-escalation and expansion cohorts.
• Develop study timelines, budgets, and resource plans; track progress against milestones.
• Ensure compliance with ICH-GCP, FDA, EMA, and other applicable regulatory guidelines , including Project Optimus and evolving oncology regulatory expectations.
• Manage relationships with CROs, vendors, and study sites, including contract negotiations and performance oversight
• Collaborate with cross-functional teams (clinical operations, medical, regulatory, data management, biostatistics, and pharmacovigilance).
• Oversee trial master file (TMF) documentation to ensure inspection readiness at all times.
• Support site selection, qualification, initiation, monitoring, and closeout activities.
• Provide leadership, training, and mentorship to clinical operations team members.
• Identify and proactively resolve study-related risks, issues, and deviations
• Prepare and present study updates to internal stakeholders and senior leadership.
Qualifications
• Bachelor’s degree in life sciences, or related field (advanced degree preferred).
• 5+ years of experience in oncology clinical research, with at least 2 years in a trial management or project management role.
• Strong understanding of clinical trial regulations, GCP guidelines, and industry best practices.
• Proven ability to manage multiple projects simultaneously in a fast-paced environment.
• Excellent organizational, leadership, and problem-solving skills.
• Strong communication and interpersonal skills for collaboration with investigators, vendors, and cross-functional teams.
• Proficiency with clinical trial management systems (CTMS), electronic data capture (EDC), and Microsoft Office Suite.
• Work hour flexibility to ensure communications with colleagues in different time zones
• Hybrid position (2+ days on-site)