CTM Sr CTM

Work Schedule

Environmental Conditions

Job Description

• Lead and manage clinical operational activities for assigned studies from start-up through study closeout.
• Ensure studies are conducted in compliance with ICH-GCP regulatory requirements sponsor expectations and company procedures.
• Develop and maintain key clinical study documents including Monitoring Plans Monitoring Guidelines and other study-specific tools.
• Contribute to the development and execution of study management plans and clinical deliverables.
• Oversee Trial Master File (TMF) quality completeness and inspection readiness.
• Collaborate with project managers sponsors CRAs start-up teams and cross-functional stakeholders to ensure study objectives are achieved.
• Lead clinical team meetings and provide guidance oversight and support to study team members.
• Monitor study timelines performance metrics risks and issue resolution activities.
• Review monitoring reports study progress query management and overall site performance.
• Support study start-up activities including ethics committee and regulatory submissions where applicable.
• Manage clinical resources workload distribution and identification of additional resource needs.
• Provide project updates and operational insights to internal stakeholders and clients.
• Support financial oversight through resource planning forecasting and budget awareness.
• Participate in client meetings hand-off meetings bid defense activities and other sponsor-facing interactions as required.
• Drive continuous process improvement initiatives and promote operational excellence across clinical programs.

• Bachelors degree in Life Sciences Nursing Healthcare or a related scientific field or an equivalent combination of education and experience.
• Ability to travel as required for business and study-related activities.

• Relevant experience in clinical research clinical operations study management or clinical trial leadership within a pharmaceutical biotechnology CRO or healthcare environment.
• Candidates may be considered for CTM or Clinical Lead opportunities based on their experience qualifications leadership capabilities and demonstrated expertise in clinical trial management.

• Strong knowledge of clinical trial operations monitoring processes and study management principles.
• Solid understanding of ICH-GCP guidelines FDA regulations and other applicable global regulatory requirements.
• Demonstrated leadership mentoring and team management skills.
• Strong project planning prioritization and organizational capabilities.
• Excellent problem-solving critical thinking and decision-making skills.
• Experience managing study timelines resources budgets and performance metrics.
• Strong interpersonal and stakeholder management skills in a global matrix environment.
• Effective written and verbal communication skills including English proficiency.
• Ability to work successfully in a fast-paced and evolving clinical research environment.
• Proficiency with Microsoft Office and clinical trial management systems.
• Strong attention to detail and commitment to quality.

Working Conditions and Environment
Work is performed in an office environment with exposure to electrical office equipment.

Frequently drives to site locations and frequently travels both domestic and international.