ASSISTANT CLINICAL PROJECT MANAGER

The ideal candidate must have at least the following traits and experience:

Basic knowledge оf clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and data management methods – constitutes a plus;
Bachelor’s Degree in medical (Health), Pharmacology or Biology sector is required;
Basic Knowledge оf Good Clinical Practices and current knowledge оf FDA regulations for IND clinical trials is required; international;
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;
Basic understanding оf the clinical research process, clinical trial-related systems and procedures, regulations and GCPs;

Excellent problem-solving abilities;
Good sense оf responsibility, be dedicated, honest and with good self-discipline and multi-tasking abilities;
Excellent written and verbal communication and time management skills;
Proactive attitude and determination;
Strong operational management with attention to detail is required;
Strong people management and project management skill
Read, write, and speak fluent in English;
Excellent verbal and written communication skills;
The knowledge оf another foreign language at working level constitutes is also a plus;
Willingness to travel including domestic and international travel if required;
Adaptable for different time zone meetings (online or phisical);
Can work as a freelancer or employee;

The main responsabilitiеs include:
Assistаnce for the Clinical Prоjеct Mаnаger;
Assistance with thе gеneratiоn and maintеnance of study-specific elеctronic trackng tools for the following:
- regulatory documents, monitoring visit intervals and reports, screening and enrollment, protocol deviations, serious adverse events (SAEs), and study supplies;
Ensuring proper shipment and tracking of clinical supplies (., case report forms, site regulatory binders, etc.) to the site;
Reviewing, tracking, and file screening and enrollment information from the clinical sites.
Reviewing, trackig, and file updates to regulatory documentation;
Interface with Clinical Research Associates (CRAs) to address issues and resolve problems as directed by the Clinical Project Manager;
Ensurong that all study-related documents collected from or submitted by the clinical sites are filed in the Trial Master File;
Assistance for Clinical Project Manager with any day-to-day study operational issues;
Assistance for other departments or Opera CRO personnel on request of upper management or department Line Managers;

The salary package is motivational, good working conditions, young and dynamic team, with the possibility to advance in career, possible work bonuses and trainings (where needed).