Senior Clinical Trial Manager (CTM)

Jobgether; United States; A distancia; USD 168.000 - 188.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote work US

Medical insurance

Life insurance

Disability benefits

401(k) matching

Stock incentives

ESPP

Bonus

Wellness benefit

PTO & holidays

Descripción de la vacante

Jobgether, on behalf of a partner company, seeks a Senior Clinical Trial Manager in the United States, remote with travel to the Boston area as needed. You will lead domestic and international trials across the full lifecycle, ensuring quality, regulatory compliance, and timely delivery.

You will collaborate with cross-functional teams to maintain trackers, TMFs, and budgets, while driving risk management and continuous improvement in clinical operations.

Formación

• Bachelor's degree in a scientific field; advanced degree is a plus.
• 5+ years of direct clinical trial management experience in a sponsor or CRO setting.
• In-depth knowledge of ICH, GCP, and regulatory requirements.
• Experience directing or coordinating clinical operations team members.
• Strong project management, organizational, and time-management skills; attention to detail.
• Demonstrated ability to identify risks, solve problems, and make sound decisions.

Responsabilidades

• Lead initiation, execution, and closeout of clinical trials in US and international sites, ensuring GCP compliance.
• Contribute to study concept, protocol design, feasibility, and start-up activities.
• Manage relationships with collaborators and external stakeholders.
• Maintain trial trackers, TMFs, regulatory submissions, budgets, and invoices.
• Coordinate IRB/EC submissions and TMF readiness.
• Oversee TMF reviews for accuracy and inspection readiness.
• Review documentation for SOP compliance and training adherence.
• Identify and mitigate study risks; escalate as needed.
• Collaborate with QA, Data Management, Biostatistics, Medical Writing, Safety, Clinical Supply, and Finance.
• Drive best practices and continuous improvement in clinical development.
• Support data exchange, analysis, and interpretation to generate evidence.

Conocimientos

Project management

Risk management

Cross-functional collaboration

Attention to detail

Communication

Educación

Bachelor's degree in science

Advanced scientific degree

Descripción del empleo

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 (CTM) based in the United States.

The Senior Clinical Trial Manager will lead the planning, execution, and closeout of domestic and international clinical trials, ensuring studies meet rigorous quality, regulatory, and operational standards. This role spans the full clinical development lifecycle, from study design and feasibility through data analysis and final reporting. You will collaborate with cross-functional teams and external partners to deliver clinical studies efficiently, on time, and within budget. The position also offers the opportunity to strengthen clinical operations practices, introduce innovative approaches to research, and support the advancement of patient care. Success requires strong project leadership, scientific understanding, and a proactive approach to risk management and continuous improvement. This is a remote opportunity within the United States, with travel to the Boston area as needed.

Accountabilities

• Lead the initiation, execution, and closeout of clinical trials, ensuring compliance with Good Clinical Practice (GCP) guidelines and international regulatory requirements.
• Contribute to study concept development, protocol design, feasibility assessments, and study start-up activities.
• Manage strategic relationships and engagement with key collaborators and external stakeholders.
• Establish and maintain clinical trial trackers covering regulatory documentation, Trial Master Files (TMFs), start-up progress, screening and enrollment, invoices, payments, and project budgets.
• Contribute to Institutional Review Board (IRB), Ethics Committee (EC), and other regulatory submissions.
• Oversee TMF reviews to ensure documentation is complete, accurate, and inspection-ready.
• Review clinical documentation to verify compliance with Clinical Operations standards, project-specific quality requirements, standard operating procedures (SOPs), and training guidelines.
• Identify, assess, and mitigate study risks, escalating issues when necessary.
• Coordinate with cross-functional teams, including Quality Assurance, Data Management, Biostatistics, Medical Writing, Safety, Clinical Supply, and Finance.
• Drive the adoption of best practices and continuous improvement initiatives across clinical development.
• Support data exchange, analysis, and interpretation to help generate reliable clinical evidence.

Requirements

• Bachelor's degree in a scientific field required; an advanced scientific degree is a plus.
• At least 5 years of direct clinical trial management experience in a sponsor or Contract Research Organization (CRO) setting.
• In-depth knowledge of clinical trial operations, ICH guidelines, Good Clinical Practice (GCP), and other applicable regulatory requirements.
• Experience directing or coordinating clinical operations team members.
• Proven ability to collaborate effectively across multiple functional areas and manage complex clinical projects.
• Strong project management, organizational, and time-management skills, with exceptional attention to detail.
• Demonstrated ability to identify risks, solve problems creatively, and make sound decisions under time pressure.
• Intellectual curiosity, an innovative mindset, and an entrepreneurial approach to improving clinical research.
• Ability to work autonomously while contributing effectively to a collaborative team.
• Excellent written and verbal communication skills, with the ability to build strong internal and external relationships.
• High standards of professionalism, integrity, accountability, and ethical conduct.
• Willingness and flexibility to travel to the Boston area as needed.

Benefits

• Annual base salary: $168,000–$188,000 USD.
• Remote work within the United States, with travel to the Boston area as needed.
• Medical, dental, and vision insurance, with 99% of premiums covered.
• Company-paid life insurance, accidental death and dismemberment (AD&D) coverage, and disability benefits.
• Voluntary insurance plans to personalize coverage.
• Dollar-for-dollar 401(k) matching on eligible contributions, up to 6%.
• Long-term stock incentives and an Employee Stock Purchase Plan (ESPP).
• Discretionary quarterly bonus.
• Flexible wellness benefit.
• Generous paid time off (PTO), paid holidays, and company-wide shutdowns.
• Opportunity to work with a collaborative team of knowledgeable, motivated, and supportive colleagues.