Clinical Trial Manager / Senior Clinical Trial Manager
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Trial Manager based in the United States.
This role offers the opportunity to lead the operational execution of complex clinical studies within a highly collaborative research environment.
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 position plays a critical role in ensuring clinical trials meet timelines, regulatory standards, and operational objectives.
Working cross-functionally with clinical, regulatory, data management, and quality teams, the role drives successful trial outcomes from feasibility through closeout.
The ideal candidate will bring strong clinical research expertise, leadership capabilities, and experience managing complex studies in pharmaceutical and/or medical device research.
This is a high-impact opportunity for an experienced clinical professional who thrives in a fast-paced, results-oriented environment.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Trial Manager based in the United States.
This role offers the opportunity to lead the operational execution of complex clinical studies within a highly collaborative research environment.
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 position plays a critical role in ensuring clinical trials meet timelines, regulatory standards, and operational objectives.
Working cross-functionally with clinical, regulatory, data management, and quality teams, the role drives successful trial outcomes from feasibility through closeout.
The ideal candidate will bring strong clinical research expertise, leadership capabilities, and experience managing complex studies in pharmaceutical and/or medical device research.
This is a high-impact opportunity for an experienced clinical professional who thrives in a fast-paced, results-oriented environment.
Accountabilities:
- 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.
- 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.
- Ability 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.
- 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.