Senior / Manager, Clinical Business Operations

Relay Therapeutics; Cambridge (MA); On-site; USD 80,000 - 130,000; Full time

Job summary

An established industry player in clinical-stage precision medicine is seeking a Senior/Manager for Clinical Business Operations. This pivotal role focuses on executing clinical site contracts and budgets, ensuring alignment with clinical trial goals. You will coordinate with various stakeholders, including Legal and Clinical Operations, to negotiate site agreements that balance risk and budget effectively. If you have a strong background in clinical research and are passionate about making a difference in patients' lives, this opportunity offers a dynamic environment where your contributions will be valued and impactful.

Qualifications

• 7+ years in clinical research with global site contracts and budgets.
• Thorough understanding of GCP and ICH Guidelines.

Responsibilities

• Manage negotiation of clinical trial agreements with investigative sites.
• Oversee CROs to ensure compliant execution of contracts and budgets.

Skills

Clinical research negotiation

GCP and ICH Guidelines knowledge

Stakeholder collaboration

Organizational skills

Communication skills

Attention to detail

Tools

MS Office

Excel

Grant Manager

Grant Plan

Job description

Senior / Manager, Clinical Business Operations

Cambridge, MA

The Opportunity:

As Manager / Senior Manager, Clinical Business Operations, you will be responsible for the execution of clinical site contracts and budgets to support the achievement of clinical trial study goals. You will coordinate activities across internal stakeholders (Legal, Clinical Operations), CROs, and study sites to effectively deliver negotiated site agreements that balance risk, budget, and speed. This role will report into the Associate Director, Clinical Business Operations.

Your Role:

• Manage the successful negotiation and ongoing management of clinical trial agreements with investigative sites, including providing status updates to key stakeholders during internal and external meetings as needed.
• Serve as main point of contact for US site negotiations and collaborate cross-functionally with CROs on ex-US site negotiations; oversee development and approval of investigator site budgets and associated negotiation parameters. Ensure cross-trial consistency in country-level site budget targets and parameters.
• Maintain oversight of CROs to ensure compliant and timely execution of site contracts and budgets.
• Leverage use of internal and CRO provided Investigator Grants reference data and available Fair Market Value (FMV) benchmarking tools to establish and negotiate site budgets.
• Proactively identify site contract/budget related issues or risks and escalate to AD, CBO and other functions (Legal, Clinical Operations) as needed to prevent delays in site activation timelines.
• Maintain site contract and budget records for all Relay Tx studies in designated study SharePoint folders for completeness and inspection readiness.
• Track and benchmark contract cycle times, adherence to site budgets, and negotiation consistency across Relay Tx studies.
• Supports negotiation of other vendor agreements or investigator-sponsored trials.

Your Background:

• You have 7+ years of experience in the clinical research industry negotiating global site contracts and budgets.
• You have Clinical Operations/Development experience with a thorough understanding of GCP and ICH Guidelines.
• You have extensive experience managing the preparation and contract negotiation process, including template development, documentation of template revisions, approvals, signature, etc.
• You can effectively collaborate with key internal and external stakeholders, including Legal, Clinical Operations, Finance, CRO, and site personnel.
• You are proficient in MS Office products with advanced knowledge of Excel, and have familiarity with grant benchmarking software (Grant Manager, Grant Plan, etc.)
• You have excellent organizational and communication skills, with a high degree of attention to detail.

About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.

Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

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