Project Manager, Start-Up

Fortrea is seeking an experienced Global Start Up Project Manager to oversee local operational clinical trial activities. The role involves ensuring regulatory and financial compliance while managing country-specific trial commitments during study start-up.

Responsibilities:

• Ownership of country and site budgets
• Development, negotiation, and execution of Clinical Trial Research Agreements (CTRA)
• Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value
• Oversight and tracking of clinical research-related payments
• Payment reconciliation at study close-out
• Oversight of FCPA, Denied Parties Screening and maintenance of financial systems
• Financial forecasting and tracking of operational budget in conjunction with the client manager
• Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols
• Development of local language materials including local language Informed Consents and translations
• Works in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols
• Deliver expertise in country-based regulations, laws, and procedures
• Provide an oversight and tracking of clinical research-related payments
• Overlook payment reconciliation at study close-out
• Responsible for managing country deliverables, timelines, and results for assigned protocols to meet country commitments
• Contributes to the development of local SOPs
• May oversee contract workers and local vendors as applicable
• Works in close collaboration internally with Clinical country operations (CRD, CRM, CTC, CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal and regional operations, Head Quarter functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones
• Collaborates closely with Regional Operations to align country timelines for assigned protocols
• Provides support and oversight to local vendors as applicable
• Oversight and coordination of local processes and SOPs
• Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management
• Enters and updates country information in clinical, regulatory, safety and finance systems
• And all other duties as needed or assigned

Requirements:

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
• In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a health care setting will be considered
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries
• Thorough understanding of the drug development process
• Fluent in local office language and in English, both written and verbal
• Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred
• Minimum of eight (8) years of clinical research experience and SSU work
• 3+ years of SUPM experience
• Global submissions experience
• Excellent communication skills, oral and written
• Self-motivation with the ability to work under pressure to meet deadlines
• Works well independently and in a team environment
• Master or other advanced degree
• PMP certification