Clinical Trial Manager

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

• Take ownership of country and site budgets while developing, negotiating, and finalizing Clinical Trial Research Agreements (CTRA).

• Supervise and monitor clinical research-related payments, ensure payment reconciliation, perform compliance checks, manage financial systems, and conduct financial forecasting.

• Implement and oversee country submissions and approvals for clinical trials pertaining to assigned protocols.

• Create materials in the local language, including informed consent documents and translations, while liaising with IRB/IEC and Regulatory Authorities.

• Manage deliverables, timelines, outcomes, quality, and compliance for protocols assigned to your country.

• Contribute to the development of local Standard Operating Procedures (SOPs) and oversee Clinical Trial Coordinators (CTCs) as necessary.

• Collaborate with CRM, CTC, CRA, Finance, and Legal teams to secure country deliverables for submissions, budgets, CTRAs, and project milestones.

• Work alongside Headquarters to synchronize country timelines.

• Support and oversee local vendors effectively.

• Manage local processes, including clinical and ancillary supplies, import/export regulations, supply destruction, filing, archiving, retention, and insurance procedures.

• Keep country information updated in clinical and finance systems.

• Ensure local regulatory and financial compliance, especially during the study start-up phase.

• Influence investigators, external partners, and country operations to achieve budget targets and adhere to payment timelines.

• Collaborate with internal country operations, finance, regulatory affairs, pharmacovigilance, legal teams, regional operations, headquarters, and external vendors, sites, IRBs/IECs, and Regulatory Authorities.

• Contribute to or take the lead on business initiatives and projects.

• Serve as a Subject Matter Expert for processes, sharing best practices, recommending improvements, and providing training.

• Mentor colleagues and disseminate best practices.

⛳️ Requirements

• Bachelor’s Degree in Business Finance/Administration/Life Sciences or equivalent experience in healthcare.

• A minimum of 5 years of experience in clinical research or a combination of Clinical Research and Finance/Business experience.

• Proficiency in core clinical systems, tools, and metrics.

• Exceptional verbal and written communication skills for influencing and training/mentoring, in English.

• Strong organizational and coordination abilities.

• In-depth knowledge of budget and contract negotiations, local regulatory environments, and submission and approval processes, along with their implications for study start-up.

• Capability to indirectly influence investigators, vendors, external partners, and country managers to address and resolve issues with minimal support from the Sr. COM or manager.

• Ability to make independent decisions with limited oversight from the Sr. COM or manager.

• Strong understanding of local regulatory environments is essential.

• Capacity to proactively develop risk management and mitigation plans within the country and resolve issues locally.

• Must be eligible to work in the United States without requiring visa sponsorship.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.