Summarized Purpose :
Provides contracted project coordination and safety support on global and domestic programs with an emphasis on serious and non-
serious adverse events, protocol inquiries, physician assessment of diagnostics, Data and Safety Monitoring Boards and Endpoint Adjudication Committees.
In collaboration with Safety Specialists and Medical Monitors, liaises and establishes effective relationships with internal functional team members to implement projects, prepare contractual documents, coordinate and facilitate meetings and accurately manage all incoming safety documentation. Essential Functions :
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 un-blinded 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 re-occurrences to PPD Data Privacy.
Performs data entry into internal / external databases, tracking systems and PPD's budget management system; performs system reconciliation's to identify issues which may negatively 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 and Experience :
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
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 initiative
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 re-prioritize 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 SOP's and WPD's for all non-
clinical / clinical aspects of project implementation, execution and closeout
Management Role :
No management responsibility
Working Conditions and Environment :
Work is performed in an office environment with exposure to electrical office equipment
Potential drives to site locations and / or travel required on rare occasion
Majority of work computer-based
Long varied hours required on occasion
Physical Requirements :
Frequently stationary for 4-6 hours per day
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
Occasional mobility required
Occasional crouching, stooping, bending and twisting of upper body and neck
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences
Frequently interacts with others to obtain or relate information to diverse groups
Works independently with guidance or reliance on oral or written instructions and plans work schedules to meet goals
Requires multiple periods of intense concentration
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
Ability to perform under stress and multi-task
Regular and consistent attendance