Agreements Specialist

Merck•North Wales, PA

5d•$96,200 - $151,400

About The Position

The Agreements Specialist prepares, reviews, negotiates, executes, and manages a broad range of clinical research and related agreements that support clinical development programs. The role partners with Clinical Trial Operations, Research & Development, Legal, Privacy, and other cross-functional stakeholders to ensure agreements are handled efficiently, compliantly, and in alignment with business objectives. The position supports site clinical trial agreements and related agreements, scientific input consulting agreements, agreements supporting MISP, and licensing and translation agreements for Clinical Outcome Assessments. It also supports related operational activities, process improvement, stakeholder collaboration, escalations, and training across regional and global teams. The primary location is North Wales (Upper Gwynedd), Pennsylvania. Travel is 10%; relocation is not offered.

Requirements

High school diploma/GED and relevant professional experience.
Minimum relevant clinical research experience depends on education: two years with a bachelor's degree, four years with an associate degree, or eight years with a high school diploma/GED.
Experience supporting clinical trial contracting, study start-up, clinical operations, or research administration activities.
Working knowledge of Site Ready processes, including Essential Document Management, Research Agreements, Budgets, and related study start-up activities.
Strong organizational, prioritization, and problem-solving skills, including the ability to manage multiple priorities in a fast-paced environment.
Ability to work effectively across cross-functional teams and with global stakeholders.
Strong written and verbal communication, negotiation, and stakeholder management skills.
Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
Required skills listed: Adaptability, Clinical Research, Clinical Study Management, Clinical Trial Compliance, Contract Negotiations, Contract Review, Data Analysis, Drug Development Research, Effective Written Communication, Good Clinical Data Management Practice (GCDMP), Interpersonal Relationships, Legal Acumen, Legal Document Review, Project Management, and Regulatory Compliance.

Nice To Haves

Bachelor's degree in Business, Legal Studies, Life Sciences, Healthcare Administration, or a related field.
Juris Doctor, attorney, or paralegal background with experience supporting clinical trial contracting and budget management.
Knowledge of global clinical research regulations and industry standards.
Good Clinical Practice (GCP) certification and/or training.
Experience with contract lifecycle management systems and clinical trial management processes.
Experience supporting global or regional clinical research organizations in a matrix environment.

Responsibilities

Review, escalate, approve, and execute site clinical trial agreements (CTRAs) and related agreements, including MCTRAs, FUAs, and CSAs, for internally managed and outsourced clinical trials.
Draft, negotiate, and execute Scientific Input Consulting Agreements and agreements supporting MISP.
Draft, negotiate, and execute licensing and translation agreements for Clinical Outcome Assessments (COAs), and support COA-related operational activities and processes.
Liaise with the Office of General Counsel, Privacy, Clinical, and other stakeholders to resolve contractual, legal, and operational issues involving investigative sites, investigators, consultants, and external partners.
Drive process improvements to reduce cycle times and improve efficiency, quality, and compliance across Global Site Agreements activities.
Collaborate with Global Clinical Trial Operations, Country Operations, Research & Development functional areas, and Global Operations stakeholders.
Respond to business requests within established timelines while maintaining quality, accuracy, compliance, and customer focus.
Participate in regional and global initiatives concerning Study Start-Up optimization, contracting excellence, and business process improvement.
Support regional and global meetings, training, and knowledge-sharing activities that promote consistent application of contracting processes and best practices.
Gather stakeholder feedback and work with the Global Site Agreements organization to identify and implement solutions.
Facilitate and manage escalations concerning contracting and process issues between regional teams, functional areas, and Global Operations leadership.