Site Contract Manager

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO, and multi-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.   

As the Site Contracts Manager (SCM I) you are a key member of the Development Operations, Central Site Services Team and is responsible for contract and budget development and negotiation with clinical sites, acting as a study functional lead for the Central Site Services team. The SCM I works directly with the Project Manager, Clients, vendors, and other internal functional teams to ensure quality deliverables on-time and on-budget. Our mission is for our Catalyst staff to operate seamlessly with our customer teams using the Catalyst site centric model to enhance employee satisfaction while giving the sites and customers the reassurance that they have a strong and experienced team. 

Position Responsibilities:

Clinical Trial Responsibilities and Accountabilities: 

• Prepares budget templates for amendment. 

• Prepares contract templates. 

• Prepares payment language terms. 

• Establishes negotiation parameters with sponsors. 

• Collaborates with Site Activation Manager to develop start up strategy plan. 

• Negotiates contracts and budgets with clinical sites. 

• Tracks negotiation progress, identifies operations issues, and escalates issues to the attention of the Project Manager or line manager. 

• Interfaces with Sponsor representatives and internal project team. 

• Responsible for filing of fully executed contracts per sponsor agreements. 

• Transfers fully executed contract to site payment group. 

• Escalate study issues appropriately and in a timely manner. 

• Responsible for understanding the CSS budget on each project and the actions required to maintain it. 

• Collaborates and supports the project team with amendments to the site contract and site budget as needed. 

• Assists with department activities and initiatives, as appropriate (e.g., process improvement). 

Project Oversight and KPI Responsibilities: 

• Prepares budget templates for amendment. 

• Prepares contract templates. 

• Prepares payment language terms. 

• Establishes negotiation parameters with sponsors. 

• Collaborates with Site Activation Manager to develop start up strategy plan. 

• Negotiates contracts and budgets with clinical sites. 

• Tracks negotiation progress, identifies operations issues, and escalates issues to the attention of the Project Manager or line manager. 

• Interfaces with Sponsor representatives and internal project team. 

• Responsible for filing of fully executed contracts per sponsor agreements. 

• Transfers fully executed contract to site payment group. 

• Escalate study issues appropriately and in a timely manner. 

• Responsible for understanding the CSS budget on each project and the actions required to maintain it. 

• Collaborates and supports the project team with amendments to the site contract and site budget as needed. 

• Assists with department activities and initiatives, as appropriate (e.g., process improvement). 

Process Development Responsibilities: 

• May contribute to SOP and JA updates and development. 

QA and Study Audit Responsibilities: 

• Responsible for ensuring that budget/CTA documentation is complete and audit ready. 

• Address questions in the audit reports. 

• Support study audits and respond to audit reports.

Position Qualifications:

Education: Bachelor’s degree or equivalent education in a related field of study. 

Experience:  At least 1 years in pharmaceutical research field (CRO, pharma, site, etc.) and 1 year of applicable industry experience negotiating contracts and budgets.  

Required Skills:  

• Must have demonstrated expertise in relevant clinical and/or business operations activities; including but not limited to site contract and budget negotiation. 

• Preferred experience with budget development platforms (Grant Manager, etc.). 

• Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results. 

• Working knowledge of ICH/GCP guidelines, Sarbanes-Oxley Act and FDA regulations (requisite knowledge may be obtained during performance of job duties through appropriate training (both on site and/or e-training programs). 

• Proficient with Microsoft Office Suite. 

• Excellent written and oral communication skills. 

• Excellent presentation skills. 

• Strong organizational, problem-solving, and analytical skills. 

• Ability to manage priorities and workflow. 

• Versatility, flexibility, and a willingness to work within constantly changing priorities. 

• Proven ability to handle multiple projects and meet deadlines. 

• Strong interpersonal skills. 

• Ability to deal effectively with a diversity of individuals at all organizational levels. 

• Commitment to excellence and high standards. 

• Creative, flexible, and innovative team player. 

• Ability to work independently and as a member of various teams and committees. 

• Good judgement with the ability to make timely and sound decisions. 

• Exceptional written and verbal communication skills. 

• Ability to read, write and speak fluent English. Client facing presentations skills. 

• Good computer skills. 

• Good working knowledge of a range of computer applications. 

• Proficient in Microsoft office (Word, Excel, PowerPoint). 

• Occasional travel to closest Catalyst or Sponsor office, as needed. 

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.