Job Title: Sr. Clinical Trial Manager / Clinical Trial Manager
Location: Remote – United States
Job Type: Regular Full-time
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 5874
Compensation Range: $113,900 – $187,800 USD (plus discretionary bonus and benefits)
Position Summary
The Sr. Clinical Trial Manager (Sr. CTM) / Clinical Trial Manager (CTM) is the clinical lead responsible for the planning, execution, and oversight of operational activities related to clinical trials. This role ensures that studies are conducted per protocol, in accordance with SOPs, ICH-GCP, and all applicable regulatory requirements.
Key Responsibilities
Clinical Leadership & Oversight
Act as the primary clinical point of contact with the client.
Lead clinical trial operations in alignment with the scope of work and project goals.
Lead internal clinical team meetings, set expectations for CRAs and CTAs, and support team cohesion.
Study Planning & Documentation
Develop clinical trial documentation (e.g., Clinical Plans, ICF templates, study trackers, forms, CRF Completion Guidelines, training materials).
Generate potential site lists and oversee the site feasibility process.
Finalize country-specific recruitment and retention strategies.
Participate in the planning and delivery of Investigator Meetings and Study Kick-Offs.
Review and approve IP release packages.
Training & Communication
Identify training needs for CRAs and vendors, and deliver study-specific training.
Maintain FAQ logs and ensure consistent communication across teams and sites.
Support scheduling and documentation of project-related meetings (agendas, minutes, action items).
Monitoring & Compliance
Develop monitoring strategies to meet study timelines and quality expectations.
Oversee eTMF implementation and management.
Support regulatory submissions to IRBs and Ethics Committees.
Utilize metrics (e.g., CTMS, query trends, monitoring reports) to assess and report on study progress.
Prepare for GCP audits and inspections; assist in CAPA development and implementation.
Vendor & Resource Management
May manage clinical vendors (e.g., labs, patient diary, home healthcare).
Collaborate with the Project Manager (PM) on project resourcing.
May assume PM responsibilities in the absence of a designated PM.
Budgeting & Contracts
Collaborate with the PM on monthly invoicing and variance tracking.
May be involved in site budget and investigator contract negotiations.
Data & Quality Oversight
Collaborate with Data Management and CRAs to ensure data quality.
May perform clinical data review of patient profiles, listings, and summary tables.
Additional Duties
Escalate CRA performance or site compliance issues as needed.
May have line management responsibilities.
Participate in business development and marketing activities as appropriate.
Perform other duties as assigned by management.
Qualifications
Minimum Required:
Bachelor’s degree (science or health-related field) or equivalent combination of education and experience.
7+ years of clinical research experience, with significant experience in clinical monitoring.
Preferred:
Advanced degree (e.g., MSc, MPH, PharmD) in life sciences or related field.
Skills & Competencies
Strong knowledge of:
ICH-GCP, Precision SOPs, global regulatory guidelines.
Clinical trial management and monitoring strategies.
Pharmaceutical and/or medical device research processes.
Technical proficiency:
Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
Clinical trial management systems (CTMS) and electronic trial master files (eTMF).
Soft skills & leadership:
Strong communication, organizational, and presentation skills.
Team leadership, delegation, and conflict resolution.
Strategic thinking, time management, and attention to detail.
Ability to inspire a culture of ownership, accountability, and excellence.
Travel:
Willingness to travel domestically and internationally, including overnight stays.
Work Culture & Ethics
High standards of integrity, professionalism, and ethical conduct.
Collaborative, cross-functional team environment.
Results-driven and client-focused mindset.
Compensation & Benefits
Base Salary Range: $113,900 – $187,800 USD (based on experience, qualifications, and location)
Other Benefits Include:
Annual discretionary bonus
Health insurance
Retirement savings plans
Life and disability insurance
Paid time off (vacation, sick leave, parental leave)
Important Notices
Fraud Alert: Precision Medicine Group does not make unsolicited job offers. All offers follow a formal interview and communication process.
To report suspected recruitment fraud, visit: https://www.ftc.gov
Equal Opportunity Employer
Precision Medicine Group is committed to fair and equitable hiring practices. All qualified applicants will receive consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
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