Senior Clinical Contracts Manager

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

📋 Description

• Lead and manage global clinical research contracting activities.

• Act as the main point of contact for negotiating, executing, and overseeing clinical research agreements.

• Direct the preparation, negotiation, execution, and management of CTAs, CSAs, CDAs, DPAs, image transfer agreements, and other study-related contracts.

• Negotiate terms of contracts, budgets, payment schedules, and essential legal provisions.

• Identify, assess, and escalate risks related to contracts, finance, legal matters, privacy, and operations.

• Ensure adherence to global privacy regulations and data transfer requirements.

• Assess clinical trial insurance needs and manage insurance documentation.

• Integrate site budgets into agreements and set up payment schedules.

• Review and process invoices, coordinate payments, reconcile financial records, and guarantee compliance with contracts and regulations.

• Collaborate with Legal, Privacy, Risk Management, Insurance, Finance, Clinical Project Management, and other business stakeholders.

• Maintain contract templates, negotiation playbooks, tracking systems, legal databases, and Trial Master Files.

• Provide updates and key metrics to leadership.

• Lead initiatives aimed at enhancing contracting efficiency, payment processing, risk mitigation, standardization, and global contracting processes.

• Track, reconcile, and report on invoices, payments, honoraria, grants, travel, meals, and other value transfers.

• Initially function as an individual contributor, with the potential for future leadership and development of direct reports.

• Perform additional duties as required.

⛳️ Requirements

• Degree Level of Qualification.

• Experience in leading and overseeing global clinical research contracting activities.

• Familiarity with clinical research agreements, including CTAs, CSAs, CDAs, DPAs, image transfer agreements, and other study-related contracts.

• Proven experience in negotiating contract terms, budgets, payment schedules, and legal provisions.

• Understanding of global privacy regulations and data transfer requirements, including GDPR, UK GDPR, HIPAA, China PIPL, and SCCs.

• Experience in evaluating clinical trial insurance needs.

• Proven track record in incorporating site budgets into agreements and establishing payment schedules.

• Experience in reviewing and processing invoices and coordinating payments to clinical sites and vendors.

• Knowledge of transparency reporting, fair market value standards, and relevant anti-bribery regulations.

• Experience in maintaining contract templates, negotiation playbooks, tracking systems, legal databases, and Trial Master Files.

• Knowledge of clinical contracting, payment processing, and managing financial, legal, privacy, regulatory, and operational risks.

• Ability to work collaboratively with Legal, Privacy, Risk Management, Insurance, Finance, Clinical Project Management, and business stakeholders.

🏝️ Benefits

• Medical, dental, and vision insurance.

• Health savings and flexible spending accounts.

• Life and disability insurance.

• Wellness resources.

• Mental health support.

• Disease management programs.

• 401(k).

• Deferred compensation programs.

• Financial counseling.

• DailyPay.

• Educational savings resources.

• Paid time off.

• Company holidays.

• Educational assistance.

• Parental leave.

• Adoption assistance.

• Backup care.

• Caregiving support.

• Employee assistance programs.

• Commuter benefits.

• Pet insurance.

• Legal services.

• Associate discount programs.

• Bereavement, military, personal, family, and medical leave.

• Jury duty leave.

• Reward and recognition opportunities.

• Competitive compensation and benefits programs.