Clinical Trial Manager / Senior Clinical Trial Manager

About the role

The Senior Clinical Trial Manager will oversee study planning, delivery, quality, and compliance while serving as a key point of contact for clients and internal teams. The role plays a critical role in ensuring clinical trials meet timelines, regulatory standards, and operational objectives.

Responsibilities

• Serve as the primary clinical point of contact for clients and provide strategic oversight throughout the lifecycle of assigned clinical studies.
• Plan, coordinate, and oversee clinical trial operations to ensure studies are conducted according to protocols, SOPs, ICH-GCP guidelines, and applicable regulatory requirements.
• Develop and manage key clinical documents, including clinical plans, informed consent templates, study-specific forms, manuals, trackers, training materials, and monitoring guidance.
• Partner with project management teams on budget oversight, invoicing, resource planning, and risk management activities.
• Lead site feasibility, recruitment, and retention strategies by collaborating with stakeholders to identify opportunities and address enrollment risks.
• Establish effective communication channels with investigators, CRAs, CTAs, vendors, and study teams to support successful study execution.
• Lead clinical team meetings, provide guidance to clinical staff, and support CRA and vendor training initiatives.
• Oversee site activation, monitoring activities, regulatory submissions, ethics committee approvals, and study closeout processes.
• Develop clinical monitoring strategies and use study metrics and reporting tools to track performance, quality, timelines, and compliance.
• Manage eTMF implementation and oversight while ensuring documentation quality and inspection readiness.
• Collaborate with quality teams and project stakeholders to develop and implement corrective and preventive action plans when required.
• Support preparation for GCP audits and ensure clinical teams and sites maintain appropriate compliance standards.
• Partner with data management teams to support data quality, query resolution, and timely database cleaning activities.
• Oversee investigational product processes, including accountability, reconciliation, and release documentation.
• Manage clinical vendors and external partners as needed, including laboratories, patient services providers, and other study-related suppliers.
• Support business development initiatives and contribute clinical expertise to proposals and client-facing activities.
• Provide leadership, mentorship, and direction to clinical teams while fostering accountability, collaboration, and continuous improvement.

Requirements

• Bachelor’s degree or equivalent combination of education and experience in a scientific, healthcare, or related discipline; an advanced degree is preferred.
• Minimum of 7 years of clinical research experience, including significant clinical monitoring and trial management experience.
• Strong knowledge of ICH-GCP principles, regulatory requirements, clinical operations processes, and industry standards.
• Demonstrated experience managing complex pharmaceutical and/or medical device clinical studies.
• Proven ability to lead cross-functional teams, delegate effectively, and create a collaborative working environment.
• Experience with clinical project planning, risk management, change management, and operational strategy development.
• Strong organizational skills with exceptional attention to detail and the ability to manage multiple priorities.
• Excellent communication, presentation, negotiation, conflict management, and interpersonal skills.
• Able to analyze data, solve problems, make informed decisions, and drive results in a dynamic environment.
• Proficiency with Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.
• Ability and willingness to travel domestically and internationally, including overnight stays when required.
• Demonstrated integrity, professionalism, accountability, and commitment to maintaining high ethical standards.

Benefits

• Competitive salary range of $110,700 - $200,900 USD, depending on skills, experience, qualifications, location, and business needs.
• Eligibility for a discretionary annual bonus program.
• Comprehensive health insurance coverage.
• Retirement savings benefits.
• Life insurance and disability benefits.
• Parental leave support.
• Paid time off, including vacation and sick leave.
• Opportunity to work in a collaborative clinical research environment with meaningful impact on healthcare innovation.