Freelancer / Contractor Project Specialist
1.0 FTEOffice based - Prague 8Up to 12 months contract
The Project Specialist performsadministrative and supportive activities assigned by the Project Lead to ensurethe contracted services and expectations are carried out by the project team inaccordance with executed contracts and the customers’ expectations.
Set-up, maintain and / or close outproject files and study information ((e.g., regulatory documents, Trial MasterFile (TMF), enrollment, Adverse Events(AEs) / Serious Adverse Events (SAEs), site supplies, Institutional Review Boardre-
approvals, data queries) on a variety of databasesand systems.
Attends, participates, prepares anddistributes meeting minutes and action items for both internal and externalmeetings (sponsor, trusted process, functional, investigator meetings).
Followsup with team members on action items to closure.
Maintains timely and effective communication amongteam members and site staff. Keeps Project Leadership and Clinical ResearchAssociates (CRAs) fully appraised of sites and study status.
May contact sitestaff as needed for critical information.
Provide administrative support toProject Leads and functional leads.
Ensure all study documents are archivedbased on the appropriate guidelines and policy.
Provide support for quality assuranceactivities, including preparation for audits and internal review, preparedocumentation and follow through to resolution on actionable issues.
Associates Degree (or equivalent) level of qualification in life sciences,Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience
Valid Czech Freelance license and availability for 1.0 FTE
Knowledge of Good Clinical Practice / ICHguidelines and other applicable regulatory requirements.
Strong organizational skills.
Ability to manage time and workindependently.
High proficiency with full MS OfficeApplications.
Strong communication, presentation,interpersonal skills, both written and spoken, with an ability to inform,influence, convince, and persuade
Ability to travel if necessarypreferred (approximately 5%)
Highlevel of competence in English and Czech language