Senior Clinical Trial Manager (CTM)

Jobgether; Oregon; Hybrid; USD 168,000 - 188,000; Full time

Benefits offered by this job

Remote US work

Travel to Boston area

Medical, dental, vision insurance

401(k) with company match

Stock incentives and ESPP

Discretionary quarterly bonus

Flexible PTO

Company shutdowns

Job summary

Jobgether is seeking a Senior Clinical Trial Manager to lead planning, execution, and closeout of domestic and international trials, ensuring quality and regulatory compliance.

The role spans the full lifecycle, collaborating with cross-functional teams to deliver studies on time and within budget while driving process improvements. This position is remote within the United States with travel to the Boston area as needed.

Qualifications

• Bachelor's degree in a scientific field required; an advanced degree is a plus.
• Minimum 5 years of direct CTM experience in a sponsor or CRO setting.
• Deep knowledge of clinical trial operations, ICH guidelines, GCP, and regulatory requirements.
• Experience directing or coordinating clinical operations team members.
• Excellent written and verbal communication skills, with the ability to work autonomously and collaboratively.

Responsibilities

• Lead initiation, execution, and closeout of clinical trials, ensuring GCP compliance and regulatory requirements.
• Contribute to study concept development, protocol design, feasibility, and start-up activities.
• Manage strategic relationships with collaborators and external stakeholders.
• Establish and maintain TMF trackers, regulatory documentation, budgets, and invoices.
• Contribute to IRB/EC submissions and other regulatory filings as needed.
• Oversee TMF reviews for completeness, accuracy, and inspection readiness.
• Identify, assess, and mitigate study risks; escalate issues as needed.
• Coordinate with QA, Data Management, Biostatistics, Medical Writing, Safety, Clinical Supply, and Finance.
• Drive adoption of best practices and continuous improvement in clinical development.
• Support data exchange, analysis, and interpretation to generate reliable evidence.

Skills

Clinical trial management

Regulatory compliance

GCP & ICH knowledge

Cross-functional leadership

Risk management

Budgets & planning

Communication skills

Travel willingness

Education

Bachelor's degree in a scientific field

Advanced degree preferred

Job description

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.