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 and physician assessment of diagnostics.
In collaboration with Safety Specialists and Medical Monitors, liaises and establishes effective relationships with functional team members to 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 reconciliations 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 :
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 work in a team or independently, demonstrating initiative to complete assigned tasks with moderate supervision
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
Working Environment :
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.
Below is listed the working environment / requirements for this role :
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. (Recruiter will provide more details.)