Agreements Specialist

MSD•North Wales, PA
•$96,200 - $151,400

About The Position

The Agreements Specialist prepares, reviews, negotiates, executes, and manages clinical research and related agreements supporting clinical development programs. The role partners with Clinical Trial Operations, Research & Development, Legal, Privacy, and other stakeholders to ensure agreements are handled efficiently, compliantly, and in alignment with business objectives. The specialist handles site clinical trial agreements and related agreements, scientific input consulting agreements, and licensing and translation agreements for Clinical Outcome Assessments. The role also supports operational processes, resolves contractual and operational issues, improves contracting processes, responds to business requests, participates in study start-up and contracting initiatives, and promotes consistent contracting practices through meetings, training, and knowledge sharing. The position is based primarily in North Wales (Upper Gwynedd), Pennsylvania. Travel requirements are 10%. The listed employee status is Regular, and relocation is not offered.

Requirements

  • At least two years of relevant clinical research experience 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, with 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.
  • High school diploma/GED and relevant professional experience.
  • Required skills listed include 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 working 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 Master Clinical Trial Research Agreements (MCTRAs), Funding Use Agreements (FUAs), and Clinical Study Agreements (CSAs), for internally managed and outsourced clinical trials.
  • Draft, negotiate, and execute Scientific Input Consulting Agreements and agreements supporting MISP.
  • Draft, negotiate, and execute Clinical Outcome Assessment (COA) Licensing and Translation Agreements, and support 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.
  • Identify and drive process improvements to reduce cycle times, increase efficiency, and enhance quality and compliance in 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 focused on Study Start-Up optimization, contracting excellence, and business process improvement.
  • Support regional and global meetings, training sessions, and knowledge-sharing activities about 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 involving contracting and process issues between regional teams, functional areas, and Global Operations leadership.

Benefits

  • Medical, dental, and vision healthcare and other insurance benefits for employees and family.
  • Retirement benefits, including 401(k).
  • Paid holidays, vacation, and compassionate and sick days.
  • Eligible for an annual bonus and long-term incentive, if applicable.
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