Clinical Operations Manager, Finance

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

📋 Description

• Oversee performance and compliance for designated protocols in alignment with ICH/GCP, local regulations, company policies, quality standards, and adverse event reporting obligations.

• Draft, analyze, negotiate, and finalize site agreements along with associated budgets throughout the contract lifecycle.

• Employ legal fallback language and budget constraints; escalate any site-specific compliance issues.

• Maintain databases and records for contracts, approvals, and budgets using consistent naming and savings conventions.

• Monitor documents and metrics to guarantee timely completion of site agreements.

• Conduct quality control assessments prior to the execution of agreements.

• Collaborate with CRM, CTC, CRA, COM-R, finance, and legal departments on Site Ready Deliverables.

• Identify potential risks and implement mitigation strategies to adhere to country timelines and commitments.

• Cultivate relationships with investigational sites and Site Management Organizations.

• Contribute to the development of local Standard Operating Procedures (SOPs).

• Review, negotiate, escalate, and facilitate the approval of Site Access Forms, EMR Access Forms, and institutional policies.

• Coordinate with Payment Coordinators/CTC-Fs to provide contingency approvals, troubleshoot issues, and amend agreements.

• Lead or contribute to business initiatives and projects.

• Serve as a subject matter expert (SME) in processes, share best practices, suggest enhancements, and provide training.

• Mentor team members and disseminate best practices.

• Influence investigators, external partners, and country operations to ensure clinical and financial contracts are within fair market value.

• Collaborate with global clinical operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, headquarters, vendors, and sites.

⛳️ Requirements

• Bachelor's Degree or higher.

• Minimum of 3 years of experience in contract or budget negotiation.

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

• Exceptional verbal and written influencing and training/mentoring capabilities in both local language and English.

• Strong organizational and coordination skills.

• In-depth knowledge of budget and contract negotiation and its impact on study initiation.

• Ability to influence investigators, vendors, external partners, and country managers with minimal assistance.

• Capacity to make independent decisions with limited oversight.

• Ability to develop risk management and mitigation strategies and address issues locally.

• Capability to lead a team of CTCs as needed.

• Strong problem-solving, time management, organizational, interpersonal, and conflict-management abilities.

• Excellent communication, leadership, negotiation, influencing, and training/mentoring skills.

• Ability to handle multiple deliverables and protocols in a remote virtual setting.

• Self-motivated and capable of working independently.

• Juris Doctor (JD) degree preferred.

• No visa sponsorship available.

• Candidates must be residents of the US or Puerto Rico.

🏝️ Benefits

• Annual bonus and long-term incentives, if applicable.

• Medical, dental, vision healthcare, and other insurance benefits for employees and their families.

• Retirement benefits, including 401(k).

• Paid holidays.

• Vacation.

• Compassionate and sick leave.

• Remote work arrangement.

• No relocation required.