Clinical Operations Senior Project Manager

The Clinical Operations Project Manager ensures oversight of the activities of setup and conduct of a clinical trial executed by a CRO in the assigned geographical region or country. He/she ensures CROs and/or other partners qualified by Dompé execute their tasks in compliance with GCP, GxPs, legal and regulatory requirements; he/she must ensure compliance with Dompé Group quality standards and policies.

He/she is also responsible for coordinating the Dompé study oversight team to ensure all actors deliver on time and on budget for the relevant studies.

• Supervises the CRO activities in all study conduct phases (start‑up, maintenance, study closure).
• Coordinates and drives the multidisciplinary team assigned to each company clinical trial in a functional matrix model.
• Participates in CRO process selection in compliance with current company SOPs.
• Manages study set‑up and progress according to company standards/regulations, ensuring committed targets are met until study completion.
• Collaborates with the local Medical Department and Site Engagement Manager to identify potential investigators for Dompé’s clinical network.
• Collects and manages input to the study protocol and operational aspects, participates in planning of Investigator Meetings.
• Works with Local Drug Supply Management to ensure IMP availability for assigned trial sites.
• Maintains knowledge of the study protocol to answer operational questions from CRAs, sites, and internal personnel.
• Ensures CRO performance meets time, budget, and quality goals by collecting, analyzing, and reporting KPI dashboards.
• Collaborates autonomously with the CRO project management team to achieve study milestones, implement corrective or mitigation plans to address risks.
• Tracks, analyzes, and reports the CRO budget for each study monthly and reconciles at study end; identifies out‑of‑scope tasks and manages change orders.
• Familiar with all relevant SOPs and ensures study documentation is archived in the Clinical Trial Master File (CTMF) per GCP.
• Ensures compliance with laws, regulations, internal control model,
  
  D. Lgs. 231/01, codes of conduct, safety, hygiene, and environmental protection within the area of responsibility.

• Bachelor’s or Master’s Degree in Pharmacology, Biotechnology or a related scientific discipline.
• 7–12 years of experience in similar roles, preferably in the pharmaceutical/life‑science sector.

Project Management Certification is preferred.

• Languages:
  
  Italian and English (fluent).
• Knowledge of productivity and collaboration tools (Google Workspace, MS Office).
• Knowledge of GCP/ICH Phase I–IV clinical trials and observational studies.
• Knowledge of research and clinical trial methodologies.
• Knowledge of the CRO industry.
• Knowledge of Project Management.
• Knowledge of the pharmaceutical sector.

• Comprehensive medical benefits.
• Generous vacation / holiday time off.
• Competitive 401(K) matching.
• Collaborative team focused on transforming lives through innovative therapies.

Compensation range: $147,817 – $175,014 per year.

At Dompé, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), incentive bonus, and benefits package customary to the position. Actual individual pay is determined based on experience, qualifications, geographic location, and other job‑related factors permitted by law.

We believe that the unique contributions of all employees create our success. To ensure our products and culture continue to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, veteran, or disability status. All your information will be kept confidential according to EEO guidelines.