Manager, Clinical Site Contracts

Revolution Medicines•Redwood City, CA

3d•Remote

About The Position

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: Revolution Medicines is seeking a motivated individual Site Contract Manager, who will support all processes related to site contracts and budgets. The individual will be involved with but not limited to drafting, advising, negotiating and executing clinical site agreements. Conducts first round of reviews to ensure final contracts and contract terms are consistent with organizational strategy, delivered by agreed upon timelines, falls within Fair Market Value and in compliance with legal, financial & regulatory requirements. This role is an individual contributor with team leadership responsibilities, reporting into the Associate Director, Site Contracts, Must have previous oncology experience.

Requirements

B.S., 8-10 years equivalent related business/ industry experience.
Experience in pharmaceutical, biotech, academia, CROs (Clinical Research Organizations).
Strong computer skills: Microsoft office and software to manage contracting.
Demonstrated leadership, stakeholder influencing without authority and negotiation skills.
Strong knowledge of a wide variety of clinical-related contract types, including, clinical trial site agreements, investigator sponsored trial agreements, research collaboration agreements, consulting agreements and confidentiality agreements.
1 + years experience with clinical budget negotiation.
Strong analytical and contract administration skills, verbal and written communication skills, and the ability to interact effectively with internal and external business partners.
High degree of dedication, motivation, and ability to work under pressure with a drive for results and the ability to engage and deliver through others.
Experience working in a global environment.
Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.
Strong problem solving skills with sound technically driven decision-making ability.
An innovative team-player with capacity to be effective in a dynamic and fast-paced company environment
Oncology experience necessary.

Nice To Haves

Big pharma/CRO experience a plus.
Grant Plan experience a plus.

Responsibilities

Ability to manage a high volume of site contract agreements from start to finish.
Help support all site contract and budget activities related to clinical trials.
Ensure consistency of contract terms with company policies and goals and best practices to enhance the contracting process.
Ensure smooth, timely, and accurate implementation of all contract terms.
Support the timely preparation and execution of all site contracts and budgets.
Responsible for entering contracts into CMS.
Demonstrated experience with clinical budget build/development using (FMV), and historical data (Grant Plan).
Strong negotiation of MCTA, ICTAs, CTAs, CSAs, CDAs, other site agreements and budgets with investigator sites (directly or with support where language necessitates), using appropriate templates, guidance, and legal/budget playbooks, liaising with ClinOps, Finance and legal for approval.
Provide input for ongoing updates of applicable legal contracts and budget playbooks and templates.
Ensure appropriate tracking of various agreements.
Effectively escalate/communicate in a timely manner to stakeholders and clinical teams regarding contract issues that could impact project deliverables.
Support in process improvement projects and continuous improvement in delivery of Global Contract Management responsibilities.
Demonstrate applicable competencies in contract management, critical thinking, highly competent in negotiation and contracting business standards.
Assist in the execution of end-to-end process is robust and is established as a way of effectively supporting the needs of key business partners while continuously monitoring and further enhancing service quality, efficiency and effectiveness and lead or support continuous improvement initiatives.
Support the contract workflow and collaboration with senior leaders to ensure efficient contract execution and suggest and implement new / more efficient processes as needed.
Involved in measuring and reporting metrics and Key Performance Indicators (“KPIs”) for in-scope service deliverables.
Participation in team meetings and collaborate with other functional groups within the company to achieve clinical study goals.
Ensure contracts and budgets are completed on time, within budget and in compliance with Standard Operating procedures (SOPs), FDA regulations and International Council for Harmonisation (ICH)/ GCP guidelines.
Communicate effectively within cross functional project teams at Revolution Medicines.