Clinical project manager

The ideal candidate must have at least the following traits:

Bachelor Degree in health or biologic science (BS/BA/ BScN or higher) is required; masters-level degree is preferred;
Experience in study project management and prior management оf contracted resources/CROs is required; site monitoring and clinical quality compliance experience are preferred;
Advanced knowledge оf Good Clinical Practices and current knowledge оf FDA regulations for IND clinical trials is required; international clinical trial experience and knowledge оf other country regulatory requirements is preferred;
Advanced computer skills including proficiency in Word and Excel are required; experience with PowerPoint and setting up MS Access database is preferred;
Excellent communication skills (oral and written) and interpersonal skills are required;
Strong operational management with attention to detail is required;
Willingness to travel up to 20% оf time including domestic and international travel is required.

Computer literate;
Strong problem-solving abilities;
Excellent written and verbal communication and time management skills;
Excellent understanding оf the clinical research process, clinical trial-related systems and procedures, regulations and GCPs;
Adaptable to different time zones meetings (online or phisical);
Availability to work after hours (when needed for time-zone purposes);
Italian language - at working level - at least speaking - constitutes a plus; if the candidate knows Italian writing as well, that is better;
Read, write, and speak fluent English; excellent verbal and written communication skills;
Must have a strong knowledge оf clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods;
Advanced English is mandatory (reading, writing and speaking).

The Clinical Project Manаger (CPM) is rеsponsible for the mаnаgеmеnt of all aspеcts оf Clinical Trial Tеam activitiеs for assigned project(s);
Mаin responsabilities include:

Serving as primary point-of-contact liaison with client to provide outstanding customer service, including participation in proposal activities and client presentations;
Overseeing and managing all aspects of a clinical research trial;
Managing the clinical study budget, ensuring that the project remains within scope and that any out of scope activities are identified and handled as appropriate;
Preparing project status updates for clients and Sr. Management team;
Serving as a member of the Project Team with the goal to contribute towards efficient management of trials.
Preparing and reviewing of protocols and other study documentation (CRF, ICF, IB, operating manuals, monitoring guidelines, etc.);
Overseeing all aspects of study site management to ensure quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports;
Establishing, updating, tracking, and maintaining study specific trial management tools/systems, and status reports;
Managing site start up procedures overseeing the recruitment of potential investigators, preparation of EC/IRB submissions, notifications to regulatory authorities, organization of meetings and other tasks as requested by the Sr. Management team;
Mentoring, training, and supervising staff at a functional level;
Assisting with review of clinical study reports;
Conducting feasibility work when requested;
Providing input to the development of proposals;
Interacting with internal work groups to evaluate needs, resources, and timelines;
Initiating payment requests for investigators;
Reviewing and developing SOPs when required;
Performing other duties as assigned by management;
Management of (Jr., Lead, Sr.) CRAs;

- other responsabilities will be detailed during interviews and will be checked in each Job Description received;

The salary package is motivational and is proportionate with each Clinical Project Manager's experience in field of work; good working conditions; young and dynamic team; possibility to advance in career;