Senior Clinical Project Manager

Job Title: Senior Senior Clinical Operations Project Manager

Type: Full-time, Permanent

Location: Spain (remote)

Responsibilities:

• Responsible for the day-to-day operations of clinical trials and the clinical trial implementation in Europe and globally under minimal supervision
• Budget management, CRO and vendor management of Phase I-III Clinical Trials
• Perform independent site management of investigative sites, external study vendors and oversight of contractors
• Participate in the development, writing and reviewing of clinical trial documents and manuals
• Supervises the CRO activities in all the study conduct phases (start-up, maintenance, study closure)
• Responsible to coordinate and drive in a functional matrix model the multidisciplinary team assigned to each of the company clinical trials
• 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;
• Collects and manages input to the study protocol and operational aspects of the study, participates in the planning of Investigator Meetings
• Maintains knowledge of the study protocol to answer standard operational questions from CRAs of the CROs, sites, and internal Country/Cluster personnel
• 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 responsible to timely identify out of scope task to be address with customized change order
• Familiarity with all the SOPs relevant to the clinical operating model in force and ensures that the study documentation is properly archived in the Clinical Trial Master File (CTMF), in compliance with the GCP requirements.

Qualifications:

• Biological and/or clinical science background
• Minimum of 5 years experience as Clinical Project Manager in a pharmaceutical or biotechnology company or CRO (monitoring, study management)
• Strong operational, presentation, documentation, communication skills, and interpersonal skills
• Experience with eTMF Veeva Vault
• Willingness to travel
• Experience in Neurology, Ophthalmology, Immunology, Rare Diseases is a plus