Agreements Specialist

Merck & Co.; North Wales (Montgomery County); In loco; USD 96.000 - 151.000; Tempo pieno

Descrizione del lavoro

Merck & Co. in North Wales, PA is seeking an Agreements Specialist to prepare, review, negotiate, execute, and manage a wide range of clinical research and related agreements across internal and external trials.

This role collaborates with Clinical Trial Operations, R&D, Legal, Privacy, and other stakeholders to ensure timely, compliant contracting that supports business objectives. The successful candidate will advance start-up activities, optimize contracting processes, and support

Competenze

• Required: High School Diploma/GED with relevant professional experience.
• Preferred: Bachelor's Degree in Business, Legal Studies, Life Sciences, Healthcare Administration, or related field.

Mansioni

• Review, escape, approve, and execute site CTRAs and other site-related agreements including MCTRAs, FUAs, and CSAs for internally managed and outsourced trials.
• Draft, negotiate, and execute Scientific Input Consulting Agreements and agreements supporting (MISP).
• Draft, negotiate, and execute Licensing and Translation Agreements for COAs while supporting COA-related activities.
• Serve as liaison with Office of General Counsel, Privacy, Clinical, and cross-functional stakeholders to resolve contractual, legal, and operational issues involving sites, investigators, consultants, and external partners.
• Drive continuous process improvement to reduce cycle times, increase efficiency, and enhance quality and compliance across Global Site Agreements.
• Maintain collaboration with Global Clinical Trial Operations, Country Operations, R&D, and Global Operations stakeholders.
• Respond to business requests within established timelines with high quality, accuracy, and compliance.
• Participate in regional and global initiatives focused on Study Start-Up optimization and contracting excellence.
• Support regional and global meetings, training sessions, and knowledge-sharing to promote consistent contracting processes.
• Gather stakeholder feedback on contracting processes and partner with Global Site Agreements to implement solutions.
• Facilitate and manage escalations related to contracting and process issues between regional teams, functional areas, and Global Operations leadership.

Conoscenze

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

Interpersonal Relationships

Legal Acumen

Legal Document Review

Project Management

Regulatory Compliance

Formazione

High School Diploma/GED with relevant professional experience

Bachelor's Degree in Business, Legal Studies, Life Sciences, Healthcare Administration or related field

Strumenti

Microsoft Office

Descrizione del lavoro

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, escape, 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

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Location

The primary location for this posting is:
USA - Pennsylvania - North Wales (Upper Gwynedd)

Compensation

Where required by law, the compensation range for this role is provided below.

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. Available benefits include 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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Additional Location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

• San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
• Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

11/4/2026

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R424152