Associate Director, Clinical Study Start-Up

Overview of Role:

We are seeking an experienced and highly motivated Associate Director to join our team. This role is crucial in managing site agreements to support our programs. The ideal candidate will have extensive experience in clinical outsourcing, site contract and budget negotiation, and managing relationships with clinical research sites. You will support clinical benchmarking and site budget development, escalation, and payment activities for the Clinical Operations department. You will partner with functional leads of departments to establish strategic approaches to fair market value negotiations and enable site activations.

Role and Responsibilities:

• Under minimal guidance, lead the development of pricing strategies for site budgets to enable contract execution and site activation
• Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with regulatory and company standards
• Negotiate and finalize site agreements, including budgets, contracts, and other necessary documentation. Knowledge of CTA legal risks and possible fallback language required.
• Rigorous analysis of budgets with the goal of securing the best price
• Confidently present the budget to the Chief Accounting Officer for approval, ensuring full knowledgeable of all details
• Partner with Clinical Finance team to provide study-wide site payment estimates and forecasts
• Work with legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contracts
• Provide regular updates to management on progress and key performance indicators related to trial agreements
• Work with Finance and Clinical Leadership as needed to address budget, invoice, payment, and PO concerns
• Collaborate with external functional service providers (FSP) on site budget templates, study-level work orders and POs, and site payment processes
• Build and maintain strong relationships with CROs, FSP providers, and clinical sites
• Monitor FSP providers and ensure adherence to project timelines, quality standards, and contractual obligations
• Identify and implement departmental processes or standards
• Assist and work with senior management on special projects
• Develop and maintain outsourcing strategies to support clinical trials across various phases
• Ensure timely and cost-effective solutions that meet project timelines and budgets
• Address and resolve any issues or disputes related to site agreements
• Collaborate with internal stakeholders, such as Legal, Clinical Operations and Clinical Development
• Develop and implement new ideas and solutions to increase the efficiency of the department
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Bachelor's degree in Life Sciences, Business Administration or related field required
• A minimum of 8+ years' experience with clinical trial site agreements in biotech or pharmaceutical setting
• Experience in oncology is highly desirable
• Strong global negotiation and contract management skills
• Experience in clinical finance, business development, or clinical operations
• Strong financial acumen and ability to understand and create budgets
• Experience working with site budgets on a global scale, and potential internal escalation pathway
• Strong knowledge of using grant plan
• Expertise in large, multi-site, clinical trials with multiple vendor types is required
• The ideal candidate will have experience working with departments that have established processes in place
• Direct experience vetting and negotiating with sites and vendors is a must
• Good understanding of the clinical process is important
• Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable
• Strong computer and database skills
• Attention to detail, accuracy and confidentiality
• Clear and concise oral and written communication skills
• Excellent communication, interpersonal and organizational skill
• Critical thinking, problem solving, ability to work independently
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
• Communicate effectively and articulate complex ideas in an easily understandable way
• Prioritize conflicting demands
• Work in a fast-paced, demanding and collaborative environment
• Knowledge of GCP guidelines and relevant regulatory requirements