Contract Manager, Clinical Site Contracts

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

📋 Description

• Responsible for the oversight of planning, drafting, negotiating, tracking, and executing site/investigator contracts, which may either be subcontracted to an external service provider or managed internally.

• Ensures that final contracts are delivered within established timelines, align with Fair Market Value, and comply with all relevant legal and regulatory standards.

• Provides study-level oversight and guidance during clinical site contract negotiations, identifies potential risks, and is accountable for the overall contracting timelines and lifecycle across various regions.

• Acts as the study-specific point of contact for the BeiGene Clinical Operations team and legal team concerning site/investigator contract and budget issues.

• Manages a team of Site Contract Associates or equivalent at the project level to ensure that contracts in the region are completed according to company standards and timelines.

• Implements necessary mitigation plans in the assigned region.

• Serves as an escalation point for unresponsive sites and site budget negotiations, ensuring that costs are approved in accordance with BeiGene FMV standards.

• Adjusts CBO’s plans and priorities to address resource and operational challenges.

• Trains and mentors new members of the local Contracts Team on financial and contractual issues while sharing experiences.

• Contributes to process improvements, knowledge transfer, and the sharing of best practices.

• Ensures all agreements are executed promptly, aiding in efficient site start-up timelines.

• Organizes and prioritizes multiple initiatives, establishing clear plans for delivery.

• Effectively communicates and escalates contract issues that may impact project deliverables to stakeholders and clinical teams in a professional and timely manner.

• Responsible for the management and administration of contracts, ensuring compliance with corporate policies.

• Serves as a backup for Site Contract Associates as needed to cover out-of-office situations.

• Ensures the proper delivery of fully executed clinical site contracts to CBO Payments teams and liaises with the CBO payments team as necessary.

• Provides substantial guidance, monitoring, and support regarding clinical site contract deliverables, including undertaking activities identified in the CBO Roles/Responsibilities and/or Study Management Plan.

• Reviews, applies, and maintains the BeiGene Playbook to enhance negotiation efficiency in collaboration with BeiGene Legal.

• Oversees a Clinical Research Organization responsible for contract negotiations, if applicable.

• Manages clinical contract management, study metric tracking, and reporting.

• Actively participates in various study meetings.

• Prepares program/study status reports.

• Maintains a system for tracking the progress and status of clinical budgets/contracts.

• Supports activities related to various contracts and subsequent contract amendments, including notes to files and other contract-related requests.

• Assists colleagues in resolving issues related to site budgets, contract terms and conditions, compliance with BeiGene policy, and other site contract-related matters.

• Delivers training to CBO colleagues or other Business Units as required.

• Acts as a point of escalation for sites that are unresponsive or slow to negotiate.

• Creates and develops effective contract templates and tools.

• Performs additional duties as assigned by management.

⛳️ Requirements

• Bachelor's degree or equivalent work experience; a degree in Health Care, business, legal, or a scientific discipline is preferred.

• At least 5 years of significant experience in Clinical Research and/or contract/budget management.

• Proficiency in Microsoft Office applications, CTMS, Contract Lifecycle Management Systems, Veeva, Jira, SharePoint, etc.

• Strong knowledge of ICH-GCP, pharmaceutical-related regulations and laws; a good understanding of the clinical trial contracting process and relevant clinical operation practices.

• Awareness and comprehension of compliance and regulatory matters in clinical research.

• Proven negotiation skills, along with strong interpersonal and business acumen.

• Excellent planning and organizational skills with the ability to work independently and effectively in a dynamic environment with competing priorities.

• A sense of urgency and strong goal orientation, with a track record of meeting deadlines and achieving goals.

• Strong written and verbal communication skills, including fluency in English and the local language (if not English) and interpersonal abilities such as conflict resolution and problem-solving.

🏝️ Benefits

• No specific benefits mentioned.