FSP Senior Site Budgets and Contracts Manager

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Position Description

Seeking a motivated individual Sr./Site Budgets and Contracts Manager, who will support all processes related to site contracts and budgets. The individual will be responsible for but not limited to drafting, advising, negotiating and executing clinical site agreements. Ensures 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 Director, Site Budgets and Contracts, must have strong oncology experience.

Duties and Responsibilities

• Strong negotiation of MCTA, CTAs, CSAs, CDAs, other site agreements and clinical budgets with investigator sites (directly or with CRO support) using appropriate templates, guidance, and legal/budget playbooks, liaising with ClinOps, Finance and legal for approval.
• Accountable for the timely preparation and execution of all site contracts and budgets.
• Ensure contracts and budgets are completed on time, within budget and in compliance with Standard Operating procedures (SOPs) and within FMV.
• Responsible for entering contracts into Contract Management System.
• Demonstrated experience with clinical budget negotiations within (FMV) using industry tools (Grant Plan preferred) for negotiations/build/development using and historical data.
• 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.
• Demonstrates a high level of applicable competencies in contract management, critical thinking, highly competent in negotiation and contracting business standards.
• Participation in team meetings and collaborate with other functional groups within the company to achieve clinical study goals.
• Communicate effectively within cross functional project teams
• 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.
• 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.
• Working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials.
• Experience working in a global environment.

Educational Requirements

• B.A./B.S., or 5 or more years of equivalent related business/industry experience

Experience Requirements

• Strong Oncology experience necessary
• 5 or more years' experience with clinical budget negotiations

Preferred Skills

• Grand plan experience a plus
• Experience in pharmaceutical, biotech, academia, CROs (Clinical Research Organizations).
• Strong computer skills: Microsoft office and software to manage contracting.
• Experience with clinical-related contract types, primarily, clinical trial site agreements and confidentiality agreements.