PV RA MW Coordinator

• Coordinates the timely review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data; tracks all necessary data and generates reports for the client, project team and/or external vendors.
• Represents the PPD DSMB/EAC Coordination Team at global and domestic committee meetings (both via teleconference and face-to-face) alongside the client, board members, third party vendors and the PPD project team, coordinating all logistical aspects and assisting with facilitation.
• Interfaces with various internal and external parties to implement projects, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations; reviewing all contractual documents for accuracy and coordinating internal and external approvals.
• Compiles adjudication dossiers and creates/submits follow-up to investigative sites.
• Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams.
• Manages project specific training and the set-up, maintenance and archival of program files; ensuring PVG remains audit ready.
• Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to PPD Data Privacy.
• Performs data entry into internal/external datases, tracking systems and PPDs budget management system; performs system reconciliations to identify issues which may negativley impact project timelines.
• Oversees expenses and manages translations; ensuring budget parameters are not exceeded.
• Answers incoming hotline calls, coordinates department functions and performs other duties as assigned.
• Supports any specific activities performed by the local office, which cannot be performed from elsewhere.
• Provides training to junior staff.

Education

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification

Experience

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
• Knowledge, skills and abilities:
• Strong problem solving skills
• Ability to work independently with minimal supervision, demonstrating initative
• Ability to build strong relationships
• Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
• Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staff
• Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
• Excellent computer skills to include: MS Office (Word, Excel, PowerPoint, Access)
• Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines
• Strong attention to detail and accuracy with orientation toward careful and meticulous work
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Flexibility to reprioritize workload to meet changing project timelines
• Demonstrated ability to attain and maintain a good working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and PPD/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution and closeout

Work Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel