Job Description

Accountable for execution and oversight of local operational clinical trial activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level at the client. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up. The ability to indirectly influence investigators, vendors, external partners, and country managers to deliver these commitments is a must. This includes adhering to budget targets and agreed payment timelines, addressing and resolving issues, maintaining expertise in country-based regulations, laws and procedures with minimal support from the client management. The position requires skilled knowledge of budget and contract negotiations, the local ethics, legislation and regulatory environment, submission and approval processes, development of local Informed Consent as well as other site ready and ongoing study deliverables. The position requires the ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

of Responsibilities:

• FINANCIAL (as applicable):
• 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.
• COUNTRY SUBMISSIONS and LOCAL LANGUAGE MATERIALS (as applicable):
• Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols. o Development of local language materials including local language Informed Consents and translations. o 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. o Provide an oversight and tracking of clinical research-related payments.
• Overlook payment reconciliation at study close-out.
• MANAGEMENT and QUALITY OVERSIGHT:
• 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.
• COLLABORATION:
• 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.
• LOCAL PROCESS OVERSIGHT: (as applicable):
• Oversight and coordination of local processes and SOPs. o 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.

Qualifications (Minimum Required):

• 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.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• 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.

Experience (Minimum Required):

• Good organizational and time management skills.
• 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.
• 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.
• Detail and process oriented.
• Positive attitude and approach.
• Interact with internal and external customers with a high degree of professionalism and discretion.
• Multi-tasking capability.
• Good computer skills with good working knowledge of a range of computer packages.
• Ability to lead and develop junior staff.
• Problem solving and Process Improvement is essential to this position. Requires the ability to pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable. Specific examples of common problems include:
• Issues in budget / CTRA negotiations.
• Quality and compliance issues.
• Regulatory and legal issues.
• Issues related to functional area deliverables that could jeopardize protocol milestones.
• Minimum of eight (8) years of clinical research experience.

Preferred Qualifications Include:

• Master or other advanced degree.
• PMP certification.

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