Clinical Project Manager

1MED SA; Circolo d'Agno; On-site; CHF 120,000 - 180,000; Full time

Job summary

1MED SA is seeking a Clinical Project Manager to lead end-to-end management of clinical trials, ensuring sponsor alignment, timelines, and quality. The role blends strategic oversight with hands-on execution, driving cross-functional collaboration across Medical Writing, Data Management, Biostatistics, and Monitoring.

The candidate will manage timelines, budgets, and vendor coordination while ensuring GCP/ISO compliance and patient safety.

Qualifications

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Biotechnology, Nursing, Medicine, Biomedical Sciences, or a related field.
• Minimum 5 years of experience in clinical research including 2 years in project management or study leadership.
• Experience in Pharmaceutical Clinical Trials and/or Medical Device Clinical Investigations.

Responsibilities

• Lead assigned teams by setting clear objectives and monitoring performance.
• Oversee full lifecycle of clinical projects including planning, timelines, and budget management.

Skills

ICH-GCP

ISO 14155

EU MDR

Project management

Stakeholder management

Budget management

English proficiency

Education

Bachelor's or higher in Life Sciences/Pharma/Medicine

Tools

EDC/eCRF

eTMF systems

CTMS

MS Office

Collaboration tools (Teams/SharePoint/Smartsheet/Monday)

Job description

The Clinical Project Manager provides leadership and end-to-end management of clinical trials, ensuring alignment with Sponsor expectations and organizational objectives. This role combines strategic oversight with hands-on project execution, fostering cross-functional collaboration and delivering studies on time, within budget, and in compliance with applicable regulations and quality standards.

Key Responsibilities

Leadership & People Management

• Lead, motivate, and manage assigned team members by setting clear objectives and monitoring performance to ensure the achievement of organizational goals in a diverse and inclusive environment.
• Identify training needs to enhance team performance and support career development.

Project Planning & Delivery

• Oversee the full lifecycle of clinical projects, including planning, timelines, budget management, and vendor coordination, as well as the review and preparation of budget amendments.
• Ensure the execution of clinical trials in compliance with agreed timelines and quality/quantity standards set with the Sponsor.
• Escalate any deviations related to quality, timelines, and budget to the direct supervisor.

Business Development & Client Engagement

• Contribute to the preparation of client proposals and support negotiations during the contracting phase.
• Act as the primary point of contact for stakeholders, providing input on feasibility, study design, budget development, and progress reporting (resources, budget, and timelines).
• Lead periodic Sponsor meetings/calls and finalize and approve related minutes.

Clinical Operations Oversight

• Coordinate all clinical services involved in the project (Medical Writing, Start-up, Data Management, Biostatistics, Feasibility, Monitoring) throughout the study lifecycle, ensuring adherence to SOPs, budget, timelines, and applicable regulations.
• Oversee monitoring activities in line with the monitoring plan, budget, and Sponsor agreements, ensuring timely delivery of monitoring visit reports.
• Deliver study-specific training (Protocol, CRF, etc.) to the internal study team and, where required, to site staff.
• Participate in Investigator Meetings and teleconferences, including preparation of meeting minutes.

Study Documentation & Trial Master File Management

• Manage Sponsor-provided study documentation and coordinate the preparation of core documents required for regulatory submissions and study approval.
• Prepare and maintain Study Manuals, Trial Master File (TMF), and Investigator Study File (ISF), ensuring proper distribution to participating sites.

Quality, Compliance & Risk Management

• Manage audit and inspection findings, ensuring appropriate corrective and preventive actions (CAPA) are implemented.
• Ensure proper handling of Serious Adverse Events (SAEs) in accordance with protocol and applicable regulations.
• Implement and maintain procedures for clinical trial management in compliance with GCP, ISO, MDD/MDR, and all applicable regulations.
• Report major protocol, GCP, and SOP violations to Quality Assurance and Top Management.

Requirements

• Bachelor's Degree or higher in Life Sciences, Pharmacy, Biotechnology, Nursing, Medicine, Biomedical Sciences, or a related scientific discipline.
• Minimum 5 years of experience in clinical research, including at least 2 years in clinical project management or study leadership roles.
• Experience in Pharmaceutical Clinical Trials and/or Medical Device Clinical Investigations.
• Demonstrated experience managing clinical studies from start-up through close-out, including oversight of timelines, vendors, study sites, and project deliverables.
• Experience working within a CRO environment is considered a strong advantage.
• Demonstrated knowledge of ICH-GCP, ISO 14155, applicable regulatory requirements, and clinical quality standards.

Key Skills

• Strong knowledge of ICH-GCP, ISO 14155, EU MDR requirements, and applicable clinical trial regulations and quality standards.
• Excellent project management skills, with the ability to oversee multiple studies, timelines, budgets, and priorities simultaneously.
• Strong leadership and team management capabilities, with the ability to motivate and coordinate cross-functional teams.
• Excellent stakeholder management and communication skills, including interaction with Sponsors, investigators, vendors, and internal teams.
• Ability to identify, assess, and mitigate project risks while ensuring delivery of study objectives.
• Strong organizational, problem-solving, and decision-making skills in a dynamic clinical research environment.
• Financial acumen, including budget planning, forecasting, and resource management.
• Commitment to quality, regulatory compliance, and patient safety.
• Professional proficiency in English, with the ability to communicate effectively in an international clinical research environment and produce high-quality scientific and technical documentation.

Systems & Technology

• Advanced experience working with EDC/eCRF platforms and oversight of study data collection activities.
• Knowledge of eTMF systems, including oversight of TMF completeness, quality, and inspection readiness.
• Proficiency in Clinical Trial Management Systems (CTMS) for study planning, tracking, and reporting.
• Knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), including preparation of project reports, metrics, and study presentations.
• Experience using project management and collaboration tools (e.g., Microsoft Teams, SharePoint, Smartsheet, Monday.com, or similar platforms).
• Ability to analyze study performance metrics, timelines, risks, and resource allocation through relevant reporting tools and dashboards.
• Familiarity with remote monitoring technologies, electronic document management systems, and digital collaboration platforms