Manager, Clinical Contracts (REMOTE)

Position Summary:

We are looking for a talented and highly motivated Clinical Operations Manager, Contracts to oversee the implementation of contracts for the company's Clinical Development Programs. This role is crucial in advancing the start-up of our projects and will act as a key cross-functional partner for financial and resource planning within Clinical Operations. Additionally, the manager will provide direct support for CRO work orders and contract modification processes.

Responsibilities:

• Execute and Manage Contracts: Oversee contracts, billing, and payments from RFP, bid comparison, and selection process for all clinical vendors.
• Financial Oversight: Track costs, analyze variances, and manage budgets for clinical milestones and pass-through expenses, including detailed site/patient analysis for financial accruals.
• Budget and Forecasting: Liaise with Finance for monthly/quarterly forecasting of clinical trial activities, ensuring accurate and timely communication of clinical costs.
• Contract Review and Modifications: Review CRO-related contract modifications and change orders in partnership with Clinical Operations, Procurement, Legal, and Finance.
• Decision Support: Facilitate trade-off discussions, provide options for emerging budget issues, and support effective decision-making.
• Operational Optimization: Assist in optimizing operations procedures, including Procure-to-Pay processes, to ensure global consistency in contract management, expense reporting, and spend analysis.
• Issue Resolution: Resolve invoicing issues with service providers, Accounts Payable, and Finance.
• Vendor Performance Analysis: Analyze proposals, budgets, and KPIs to understand vendor financial and project performance.
• Contract Preparation: Prepare, negotiate, track, and finalize CDAs, CTAs, budgets, LOIs, and amendments as needed.
• Site Contract Management: Manage all contractual agreements with investigator sites, including negotiation, tracking, and finalization.
• Risk Management: Proactively identify site contract-related risks and potential roadblocks.
  
  

Additional Skills & Qualifications:

• Education: Bachelor’s degree in a related field preferred.
• Industry Experience: Experience in Pharma, CRO, or Biotech.
• Clinical Knowledge: Understanding of clinical operations processes and clinical trials (Phases I-III).
• Professional Experience: 5+ years in clinical, drug development outsourcing.
• Technical Skills: Proficiency in MS Excel and Word.
• Financial Skills: Strong financial acumen with the ability to evaluate budgets, accounting, and develop business cases.
• Project Financial Management: Knowledge of vendor contract financial forecasting and expense recognition.
• Collaboration: Ability to work effectively with internal and external customers/vendors to meet project-specific goals; familiarity with contract negotiations.
• Regulatory Knowledge: Understanding of industry standards and applicable guidelines; FDA regulations and ICH GCP knowledge preferred.
• Soft Skills: Strong collaboration, communication, and organizational skills with attention to detail.
• Problem-Solving: Excellent problem-solving and analytical skills.
• Independence: Ability to function independently within a team framework.
• Multitasking: Ability to multi-task, prioritize, and manage time effectively.
• Interpersonal Skills: Ability to interact with sites, clients, and other functional areas as the project contact for contracting issues and questions.
  
  

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people
  
  

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.