Regional Contracts Lead – Clinical Site Contracts

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

📋 Description

• Supervise and ensure timely execution of regional clinical contract agreements, which encompass CTAs, investigator agreements, confidentiality agreements, ancillary agreements, pharmacy agreements, site master service agreements, consulting agreements, single-service agreements, and subcontractor agreements.

• Lead the regional Clinical Contracts team, comprising Contract Managers and Contract Associates or their equivalents.

• Provide both individual and group feedback to facilitate ongoing team development.

• Execute Investigator Contracts under Power of Attorney when authorized by BeOne Medicines Legal and Tax.

• Maintain and enhance negotiation processes to fulfill financial and operational requirements.

• Ensure that negotiations for clinical site budgets stay within fair market value and adhere to internal approval guidelines.

• Collaborate with Clinical Operations and CBO colleagues to enhance clinical site contract and budget metrics and to implement efficient processes.

• Establish standards across clinical site contract and budget processes, supporting continuous improvement while developing strategies aligned with therapeutic areas.

• Act as the regional escalation point for Clinical Site Contracts, providing oversight at the regional program level.

• Utilize industry tools and data sources to deliver feedback on budgets and contracts that align with company parameters and fair market value guidelines.

• Identify potential delays, propose solutions, and escalate instances of nonperformance.

• Oversee and guide clinical site contract negotiations, identifying risks and managing contracting timelines and lifecycle.

• Ensure that regional contracts are finalized in accordance with company standards and timelines; implement mitigation plans as necessary.

• Develop and put into practice policies and procedures based on identified needs.

• Execute additional tasks as requested by departmental and company leadership.

⛳️ Requirements

• Bachelor’s degree; JD is highly preferred or a minimum of 8 years of exceptional experience in managing and negotiating clinical trial agreements and budgets.

• Essential experience in the CRO or pharmaceutical industry.

• Strong knowledge of ICH-GCP, and pharmaceutical-related regulations and laws.

• Solid understanding of clinical trial contracting processes and relevant clinical operations practices.

• Awareness of compliance and regulatory issues in clinical research.

• Proven skills in negotiation, interpersonal relations, and business acumen.

• Excellent planning and organizational abilities; capacity to work independently and effectively in a dynamic environment with competing priorities.

• Strong sense of urgency and goal orientation; a proven track record of meeting deadlines and achieving objectives.

• Exceptional written and verbal communication skills, including fluency in English and the local language if not English.

• Strong interpersonal abilities, including skills in conflict resolution and problem-solving.

• Proactive and positive team player; capable of maintaining high performance amidst ambiguity and change.

• Financial, budget, cost management/analysis, accounting, and/or financial planning skills are advantageous.

• Knowledge of intellectual property, publication, indemnification, and other standard clinical site contract matters.

• Willingness to work in a fast-paced environment with time-sensitive material.

• Demonstrated effectiveness in working at all levels of an organization.

• Proficiency in Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, SharePoint, etc.

• Willingness to travel 10% of the time.

🏝️ Benefits

• Competitive compensation package including a performance-based annual bonus scheme.

• Company shares (generous welcome grant!).

• Opportunities for in-house and external learning and development.

• Excellent benefits program.

• Chance to work with a dynamic, collaborative, supportive, inclusive, and enjoyable team.