CTM/ Sr. Clinical Trial Manager

Responsibilities

• Lead cross-functional teams throughout the lifecycle of clinical trials, including start-up, execution, and close-out. Serve as the primary contact for study-related activities and updates to internal leadership.
• Contribute to clinical trial strategy, including protocol input, country and site selection, vendor identification, risk management, and development of study timelines and budgets. Lead or support the development of protocols, amendments, clinical study reports, and related documents.
• Oversee the development and maintenance of key study documents such as informed consent forms, monitoring plans, submission packages, GDPR compliance materials, and annual reports. Drive vendor and CRO performance through oversight plans, performance tracking, and issue resolution. Foster strong partnerships with investigators, site staff, and external partners.
• Identify and proactively manage study risks with mitigation strategies and appropriate escalation. Ensure compliance with GCP, SOPs, and regulatory requirements across all operational activities. Champion inspection readiness and support audits and regulatory inspections, including CAPA development.
• Lead the study-level budgeting and site contracting process, in partnership with legal and finance teams. Monitor vendor performance and review invoices, change orders, and scopes of work to ensure financial accountability.
• Oversee CRO management of the Trial Master File (TMF), ensuring completeness and quality. Ensure timely and accurate registration and updates in clinical trial registries (e.g., ClinicalTrials.gov).
• Identify and implement opportunities to improve clinical operations processes and drive efficiency. Contribute to departmental goals and strategic initiatives.

Qualifications

• Bachelor's degree in a life sciences or healthcare-related discipline (advanced degree a plus).
• Minimum of 6 years of experience in clinical trial management within biotech or pharmaceutical industry.
• Proven ability to manage vendors and CROs, driving accountability and high-quality deliverables.
• Deep knowledge of clinical trial regulations and guidelines (ICH-GCP, FDA, EMA, etc.).
• Strong project management skills with a proactive, solutions-oriented mindset.
• Excellent interpersonal, communication, and organizational skills.
• Ability to work independently and collaboratively in a dynamic, cross-functional team environment.
• Willingness to travel up to 15%, including international travel.