Clinical Operations Senior Project Manager

Clinical Operations Senior Project Manager

Job Area: R&D/Medical

Job Category:
Professionals

Job Site:
Remote

Location:

San Mateo, CA, US

Dompé is an Italian bio-pharmaceutical company that focuses on innovation, where a long tradition in the field of personal wellness goes hand‑in‑hand with a commitment to research and development to meet unsatisfied therapeutic needs.

Established in 1940 in Milan, Dompé has an industrial and biotech research hub in L’Aquila, in addition to branches in Europe (Barcelona, Berlin, Paris and Tirana). The company has approximately 900 employees. The US headquarters of Dompé are based in Boston (R&D) and in the San Francisco Bay Area (Commercial Operations).

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

He/she is also the responsible person to coordinate the Dompé study oversight team, assigned to ensure that all actors can deliver on time and on budget for the relevant studies.

• Supervises the CRO activities in all the study conduct phases (start‑up, maintenance, study closure);
• Is responsible to coordinate and drive in a functional matrix model the multidisciplinary team assigned to each of the company clinical trials;
• Is involved in the CRO process selection in compliance with current company SOPs;
• Is responsible for set‑up and progress of the study according to the company current standards/regulation and ensures that committed targets are met until study completion;
• Collaborates with the local Medical Department and Site Engagement Manager to identify potential investigators to be included in the clinical network of Dompé;
• Collects and manages input to the study protocol and operational aspects of the study, participates in the planning of Investigator Meetings;
• Works with Local Drug Supply Management and ensures IMP is available to commence and complete assigned trial/assigned trial sites;
• Maintains knowledge of the study protocol to answer standard operational questions from CRAs of the CROs, sites, and internal Country/Cluster personnel;
• Ensures the performance of the CRO assigned to the study in order to be on time, budget and quality by collecting, analyzing and reporting detailed performance KPI dashboards;
• Closely collaborates in autonomy with the CRO project management team in order to ensure that anticipated study milestones and target are met and in order to put in place corrective or mitigation plans to address risks that may impact missing study objectives;
• Is in charge of tracking, analyze and report the CRO budget for each assigned study on a monthly basis and of final reconciling at the end of the study; as such he/she is also responsabile to timely identify out of scope task to be address with customized change order (CO);
• Must be fully familiar with all the SOPs relevant to the clinical operating model in force at Dompé and ensures that the study documentation is properly archived in the Clinical Trial Master File (CTMF), in compliance with the GCP requirements;
• Ensures compliance with laws and regulations in accordance with the provisions of the internal control model,
  
  D. Lgs. 231/01 and codes of conduct within the area of responsibility;
• Ensures compliance with legal obligations and procedures regarding safety and hygiene at work as well as environmental protection within the area of competence.

• Bachelor’s/Master’s Degree in Pharmacology, Biotechnology or related scientifc discipline;
• 7‑12 years of experience in similar roles, preferably in the Pharmaceutical/Life‑science sector.

Project Management Certification is preferred.

• Languages:
  
  Italian English (fluent);
• Knowledge of the main productivity and collaboration tools (Google Workspace, MS Office);
• Knowledge of GCP/ICH phase I‑IV clinical trials and observational studies;
• Knowledge of…