How you’ll contribute:

We are seeking an experienced CTM who has leadership experience to lead our clinical trial. The CTM is responsible for delivering high-quality clinical trial execution across assigned studies. This role combines advanced monitoring expertise with hands-on clinical trial management responsibilities, including vendor oversight, study planning, site management, and cross-functional coordination. The ideal candidate brings strong leadership, independent judgment, and the ability to proactively identify risks while ensuring compliance with ICH-GCP, regulatory requirements, and internal SOPs.

What you’ll bring:

Study Management & Execution

• Lead day-to-day management of assigned trial
• Develop and maintain study timelines, milestones, and budgets
• Oversee study start-up, site activation, enrollment, maintenance, and closeout
• activities
• Identify risks and implement mitigation strategies to ensure study delivery
• Manage study and site budget
• Manage changes to the SOW for study, sites, and vendors

Vendor & CRO Oversight

• Manage CROs and external vendors to ensure performance aligns with scope,
• timelines, and quality expectations
• Review vendor deliverables, KPIs, and budgets
• Lead vendor meetings and escalation management

Site & Monitoring Oversight

• Provide oversight of CRAs and monitoring activities to ensure data quality and

compliance

• Support site selection, feasibility, and engagement strategies
• Ensure timely issue resolution at study sites

Regulatory & Compliance

• Ensure compliance with ICH-GCP, FDA, and global regulatory requirements
• Oversee TMF inspection and readiness
• Support regulatory submissions and audit/inspection activities

Cross-Functional Leadership

• Act as the primary liaison across Clinical, Data Management, Biostatistics,

Regulatory, Safety, and Medical teams

• Lead study team meetings and provide regular status updates to stakeholders
• Drive decision-making and alignment across functions

Data & Reporting

• Review study metrics, enrollment, and data quality indicators
• Ensure timely database lock and study deliverables
• Contribute to clinical study reports and publications

Qualifications and Requirements

Experience

• Bachelor’s degree in Life Sciences or related field (advanced degree preferred)
• 5–8+ years of clinical research experience, including trial management
• Experience managing global, multi-site clinical trials
• Strong knowledge of clinical operations, ICH-GCP, and regulatory requirements
• Experience with CRO/vendor oversight
• Proficiency in CTMS, eTMF systems (e.g., Veeva Vault), and Microsoft Office
• Medical Device experience preferred
• Up to 50% travel required

Skills & Competencies

• Strong leadership and cross-functional collaboration skills
• Excellent project management and organizational abilities
• Ability to manage multiple studies and priorities simultaneously
• Strong problem-solving and risk management skills
• Effective communication and stakeholder management
• Detail-oriented with a focus on quality and compliance.

What we´ll offer:

We’re proud to offer exceptional corporate benefits which include:

• 22 days of PTO with the possibility to carry over 10 days to the following year.
• Company Holidays, plus your Birthday off!
• Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).
• Flexible work schedule
• And more to come!