Manager, Clinical Study Start-Up

Overview of Role:

We are seeking an experienced and highly motivated Manager to join our team. This role is crucial in managing feasibility and site agreements to support our clinical programs. The ideal candidate will have extensive experience in feasibility, study start-up, site contact 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:

• Manage and may lead the day-to-day operations within Study Start Up to ensure completion of established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g. study teams) to support timely completion of both drug and non-drug program goals and objectives.
• Negotiate and finalize site agreements, including budgets, contacts, and other necessary documentation.
• Provide accurate and up-to-date project status and financial information within relevant tracking systems/tools.
• Confidently present the budget to the Head of Clinical Operations and Chief Accounting Officer for approval, ensuring full knowledge of all details
• Partner with Clinical and 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 contacts
• 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.
• Proactively identify and escalate issues that arise related to support functional deliverables.
• Provide oversight and direction to team members for functional and study-related deliverables.
• Facilitating the development of the SSU Strategy and ensuring management of the strategy during the study start up period.
• Build relationships with key study team counterparts to support successful site activation strategies and ensure appropriate delegation of tasks during SSU.
• Contribute to process and tool development to the support of the SSU team with day-to-day activities
• Under minimal guidance, develop 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
• 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
• 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 innovative ideas and solutions to increase the efficiency of the department
• Actively participate in Study Team Meetings and work cross functionally with Clinical Operations, Legal, and Finance Provide metrics on study site progress towards activation within local Study Delivery Team and US SM&M leadership as required.
• All other duties as assigned

Required Experience, Education and Specialized Knowledge and Skills:

• Degree in Life Sciences, Business Administration or related field highly preferred; equivalent years of clinical and industry experience will be considered
• A minimum of 5-7 years experience for manager level, or 10+ years’ experience for Sr. Manager, with feasibility, study start-up, clinical trial site agreements and eTMF in biotech or pharmaceutical setting.
• Must have knowledge of clinical trial conduct, including multi-center, global trials.
• Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
• Experience in working cross functionally and with external providers
• Experience with development & implementation of process improvement related initiatives
• 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 skillsMust be able to effectively multi-task and manage time-sensitive and highly confidential documents
• Work in a fast-paced, demanding, and collaborative environment
• Knowledge of GCP guidelines and relevant regulatory requirements
• Strong knowledge of using grant plan or similar benchmarking tool
• Direct negotiating with sites and vendors is a must
• Good understanding of the clinical operations process

Highly Preferred Skills and Experience:

• Global Experience with site activation activities including submission requirements.
• Efficiently manage successful execution of feasibility and study start-up for Global Phase 2 and Phase 3 trials.
• Strong global negotiation and contract management skills
• Strong financial acumen and ability to understand and create budgets
• Experience working with site budgets on a global scale, and potential internal escalation pathway
• Expertise in large, multi-site, clinical trials with multiple vendor types is preferred