Education and Experience Requirements:

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
  
• Bachelor's degree preferred.
  
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).
  
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
  

Knowledge, Skills and Abilities:

• Ability to work in a team or independently as required
  
• Strong organizational skills and attention to detail, with proven ability to handle multiple tasks efficiently and effectively
  
• Proven ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
  
• Strong customer focus
  
• Demonstrated flexibility and adaptability to reprioritize workload and provide efficient support to meet changing project timelines
  
• Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout
  
• Excellent English language and grammar skills and proficient local language skills as needed
  
• Good presentation skills
  
• Excellent computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems
  
• Ability to successfully complete PPD clinical training program
  
• Self-motivated, positive attitude with effective strong interpersonal skills
  

• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trials activities detailed on the task matrix.
  
• Performs department, Internal, Country and Investigator file reviews as assigned and documents findings in appropriate system.
  
• Ensures allocated tasks are performed on time, within budget and to a high quality standard. Proactively communicates any risks to project leads and line manager as appropriate.
  
• Supports the maintenance of study specific documentation and global support with specific systems, tools and trackers including but not limited to: study team lists, tracking of project specific training requirements, system access management for organization/vendor/clients, and tracking of project level activity plans in appropriate system. Ensures (e)TMF is up to date by following file review schedules and documents findings in appropriate system.
  
• Provides system support (i.e. GoBalto & eTMF).
  
• Supports RBM activities.
  
• Performs administrative tasks on assigned trials including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members.
  
• Supports scheduling and organization of client and/or internal meetings with completion of related meeting minutes.
  
• Reviews and tracks local regulatory documents.
  
• Transmits documents to client and centralized IRB/IEC.
  
• Analyzes and reconciles study metrics and findings reports. Assists with clarification and resolution of findings related to site documentation.
  
• Maintains vendor trackers.
  
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
  
• Assists with study-specific translation materials and translation QC upon request.
  
• May attend Kick off meeting and take notes when required.