Job Description
The Agreements Specialist is responsible for the preparation, review, negotiation, execution, and management of a broad range of clinical research and related agreements that support the successful delivery of our clinical development programs. This role serves as a key partner to Clinical Trial Operations, Research & Development, Legal, Privacy, and other cross-functional stakeholders to ensure agreements are executed efficiently, compliantly, and in alignment with business objectives.
Primary Responsibilities
•Review, escalate, approve, and execute site clinical trial agreements (CTRAs) and other site-related agreements, including Master Clinical Trial Research Agreements (MCTRAs), Funding Use Agreements (FUAs), and Clinical Study Agreements (CSAs) for both 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), while supporting COA-related operational activities and processes.
•Serve as a key liaison with the Office of General Counsel, Privacy, Clinical, and other cross-functional stakeholders to resolve contractual, legal, and operational issues involving investigative sites, investigators, consultants, and external partners.
•Drive continuous process improvement initiatives by identifying opportunities to reduce cycle times, increase efficiency, and enhance quality and compliance across Global Site Agreements activities.
•Maintain effective collaboration and partnership with Global Clinical Trial Operations, Country Operations, Research & Development functional areas, and Global Operations stakeholders.
•Respond to business requests within established timelines while ensuring a high level of quality, accuracy, compliance, and customer focus.
•Participate in regional and global initiatives focused on Study Start-Up optimization, contracting excellence, and other business process improvement projects.
•Support regional and global meetings, training sessions, and knowledge-sharing activities to promote understanding and consistent application of contracting processes and best practices.
•Gather stakeholder feedback on contracting and agreement processes and partner with the Global Site Agreements organization to identify and implement solutions.
•Facilitate and manage escalations related to contracting and process issues between regional teams, functional areas, and Global Operations leadership.
Education
Required:
•High School Diploma/GED and relevant professional experience.
Preferred:
•Bachelor's Degree in Business, Legal Studies, Life Sciences, Healthcare Administration, or a related field.
Experience and Skills
Required:
•Minimum of: Two (2) years of relevant experience in a clinical research environment with a Bachelor's degree; or Four (4) years of relevant experience in a clinical research environment with an Associate's degree; or Eight (8) years of relevant experience in a clinical research environment 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.
•Demonstrated ability to work effectively across cross-functional teams and global stakeholders.
•Strong written and verbal communication, negotiation, and stakeholder management skills.
•Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
Preferred:
•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.
Required Skills: 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, Regulatory Compliance
Location and Compensation
The primary location for this posting is: USA - Pennsylvania - North Wales (Upper Gwynedd).
The salary range for the primary location of this role is: $96,200.00 - $151,400.00. This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits, including medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days.
Additional Details
•Employee Status: Regular
•Relocation: No relocation
•VISA Sponsorship: No
•Travel Requirements: 10%
•Flexible Work Arrangements: Not Applicable
•Shift: Not Indicated
•Valid Driving License: No
