Precision Medicine Group is looking for a Senior Manager, Clinical Trial Management (Sr. MCTM). This role provides a career development path for clinical research professionals, focusing on the management, mentorship, and growth of Clinical Trial Managers (CTM, Sr. CTM, Principal CTMs) and MCTMs. You will strengthen departmental quality and productivity while leading a team to deliver results aligned with our commitment to quality, people, clients, and performance.
What You'll Do
- Develop, mentor, coach, and manage CTMs, PCTMs, and MCTMs to advance their skills per company quality standards.
- Advocate for individual growth and career development for team members.
- Collaborate with the Clinical Operations Management Team and other functions to improve CTM procedures, promoting quality, consistency, efficiency, and achievement of KPIs.
- Provide leadership and oversight on clinical programs, potentially serving in a managerial capacity for Clinical Trial Oversight.
- Work with the Resourcing team to ensure Clinical Operations resource allocations and needs are met.
- Generate action plans and provide developmental oversight to optimize CTM services and the delivery of team goals.
- Provide ongoing feedback and manage the performance of direct reports.
- Offer technical support and guidance to assigned CTMs on scope, risk, escalation, resource planning, and deliverables.
- Ensure assigned CTMs have proper resources, training, materials, and system access to fulfill their roles.
- Identify quality risks and recommend corrective action plans to leadership for performance deficiencies.
- Interact with Project Managers and Directors to escalate and resolve clinical study issues, including out-of-scope activities.
- Ensure CTMs uphold high-quality standards and comply with SOPs, guidelines, project plans, and regulatory requirements.
- Develop and revise Clinical Operations SOPs, work instructions, forms, and templates.
- May develop and review clinical documents such as Clinical Monitoring Plans, Reference Manuals, Informed Consents, and site recruitment plans.
- May participate in interviewing new CTMs and provide onboarding training in conjunction with HR and Learning & Development.
- Ensure CTMs provide timely and accurate updates of all required administrative materials on company systems.
- Perform other duties and departmental initiatives as assigned by Leadership.
What We're Looking For
- A graduate, postgraduate, 4-year college degree, or equivalent experience in a scientific or health-related field.
- 10+ years of industry experience in clinical research, including clinical operations in a pharmaceutical company or CRO.
- 5+ years of direct supervisory/line management experience in clinical research, preferably with CTMs or CRAs.
- Working knowledge of ICH GCP guidelines and the clinical development process.
- Excellent communication, interpersonal, organizational, and customer service skills.
- Ability to travel domestically and internationally, including overnight stays.
- Direct work experience in a global, cross-functional clinical management environment.
- Proven experience in people management with a high capacity for Emotional Intelligence.
- Ability to develop, coach, mentor, and hold CTM staff accountable for goals and training needs.
- Proven experience in risk management and change management.
- A high level of integrity and the ability to inspire and demand high standards from assigned CTMs.
- High self-motivation and ability to work independently and as part of a team.
- Excellent time management, negotiation, critical thinking, decision-making, analytical, and interpersonal skills.
- Excellent presentation, verbal, and written communication skills.
- Demonstrated successful independent negotiation and conflict management strategies.
- A high degree of professionalism, punctuality, and commitment to a service culture.
Nice to Have
- Experience managing clinical aspects of complex and global trials.
- Experience managing CTM line managers (Manager level).
Technical Stack
- Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
Team & Environment
You will manage CTMs, PCTMs, and MCTMs, and work closely with the Clinical Operations Management Team and other functional areas. This role reports to Leadership.
Work Mode
This position is remote, open to candidates located anywhere in Canada.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.
