Sr./Site Contract Manager - Contractor

Job Description

Sr./Site Contract Manager

The Opportunity

Seeking a motivated individual Sr./Site Contract 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, Clinical Vendor and Outsourcing, must have strong oncology experience.

Required Skills, Experience And Education

• Ability to manage a high volume of site contract agreements from start to finish. 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.
• Accountable for 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.
• Lead process improvement projects and continuous improvement in delivery of global Contract Management responsibilities.
• Demonstrates a high level of applicable competencies in contract management, critical thinking, highly competent in negotiation and contracting business standards.
• Ensure 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.
• Manage contract workflow and collaboration with senior leaders to ensure efficient contract execution and suggest and implement new / more efficient processes as needed.
• Responsible for 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
• B.S., 5 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.
• 3 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.
  
  

Preferred Skills

• Strong Oncology experience necessary.
• EX US Contract negotiating a must.
• Big pharma/CRO experience a plus.
• Grant Plan experience a plus.
  

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.