Here at Syneos Health, we are looking for a Clinical Operations Lead (Clinical Trial Manager) to be home based in Rome, working sponsor dedicated to one of our best clients.

Why us?

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

JOB SUMMARY:

The Clinical Operations Lead (COL) serves as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study(ies). The position as defined by scope provides leadership, mentoring, and technical support to the Clinical Operations team to ensure quality of deliverables and achievement of financial goals. May provide administrative line management, which includes oversight of training, compliance, performance and career management, and development of direct reports.

JOB RESPONSIBILITIES:

• Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members;
• Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets;
• Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met;
• Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s;
• Assessment and set up the of vendors during study start up period (locally);
• Investigator Meeting participation and preparation;
• Validation of study related materials (i.e. protocol, ICF, patient material);
• Prepares materials for Site Initiation Visits;
• Responsible for verifying and confirming with local team eTMF completeness (Country and Site level);
• Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues;
• Coordination of database locks and query follow up and ensures timelines are met;
• Coordination of study related activities on a multi-country level (Italy, Greece and Israel);
• Ensure inspection readiness of assigned trials within country and provide support to Health Authority inspection and pre-inspection activities;
• Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
• Lead study team meetings locally;
• Preparing and approving payments (based on GOA) and manage patient compensation claims (if applicable);
• Management of Site relationships (includes CRO related issues);
• May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs);
• May perform site closure activities, including post-close out;
• May act as point of contact for Sites;
• May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.

• Bachelors or Masters Degree within life sciences or equivalent;
• Minimum of 4 years' industry related experience;
• Monitor experience and project management capabilities as a Lead CRA or CTM;
• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives;
• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment;
• In depth knowledge and understanding of clinical research processes, regulations and methodology;
• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management;
• Demonstrated organizational and planning skills and independent decision-making ability;
• Strong organization and time management skills and ability to effectively manage multiple competing priorities;
• Ability of critical thinking and risk analysis;
• Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels;
• Skilled in the use of technology;
• Good verbal and written communication skills (both in English and local language).

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Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.