Clinical Contract & Pricing Specialist
Kelly Science and Clinical FSP is currently seeking a Clinical Contract & Pricing Specialist I for a contract position through the end of this year with liklihood of extension after that. Local candidates preferred in West Chester, PA or Raynham, MA. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K (no match) and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
The Clinical Contract/Pricing Specialist will support the Business Strategy and Scientific Affairs Leaders by managing clinical trial and research-related contracts for multiple orthopedic programs. Collaborating closely with scientific/clinical affairs, project management, finance, compliance, procurement, and legal teams, this role is responsible for overseeing the development, negotiation, fair market value assessment, and execution of contracts (e.g., clinical trial agreements, confidentiality agreements, SOWs, amendments) with external partners, vendors, and investigative sites. This role ensures all contract activities are aligned with company and departmental policies, timelines, and budgetary requirements, and will utilize contract management systems (such as Icertis, eMarketplace, Totality, Gensight PMT, Sharepoint, and others) in support of these processes. The Clinical Contract/Pricing Specialist will be key to identifying and implementing process improvements and serving as a resource in resolving contractual, legal, and operational issues across partnering teams.
This individual will prepare, negotiate and finalize agreements and budgets related to clinical trials directly sponsored by the Company or through the Investigator Initiated/Collaborative Research Program. The Clinical Contract/Pricing Specialist will provide support to the clinical team in the pricing, planning, execution and control of site/investigator budgets and contracts.
The activities include drafting, implementing, monitoring, and evaluating compliance with company sponsored research and investigator initiated/collaborative research related to contractual requirements. Additional responsibilities may also include financial disclosures, sanction checks, conflict of interest activities, and Third-Party Intermediary due diligence.
SECTION 2: DUTIES & RESPONSIBILITIES*
• Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored, investigator-initiated/collaborative studies, and real-world evidence studies.
• Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate.
• Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and the Company pricing guidelines. Participate in and/or lead approval escalations as appropriate.
• Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
• Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
• Track all aspects of legal documents and metrics. Determine potential needs for contract amendments and manage amendment lifecycle.
• Work proactively to provide recommendations to improve processes and procedures to establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial agreements.
• Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
• Adhere to SOPs, ethics and departmental compliance as determined by corporate, HCC and QA guidelines.
• If applicable, region specific deliverables will be specified.
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management according to expectations (metrics) and archiving retention requirements.
• Oversees the maintenance of an internal database for site-related costs and analyzes changes.
• Ensures the maintenance of accurate, project-specific financial working files.
• Provide internal communication of important contract status, changes in contract requirements/regulations and events.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Maintain electronic repository system and ensure all files are uploaded and current.
SECTION 3: EXPERIENCE AND EDUCATION*
Education
• Minimum of a Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, Biological Science, Finance, Business and/or Law.
Experience
• A minimum of 3 years of relevant experience (or equivalent) required.
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) required
• Experience in contracts management required and payment processing, HCC a plus.
• Previous clinical research or related technical experience and legal experience a plus
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
• Requires understanding of Good Clinical Practices
• Strong and proven negotiation and problem resolution skills.
• Understanding and application of regulations and standards applied in clinical areas/regions is required
• Good presentation skills and effectively influencing of others
• Written and oral communication skills
• Demonstrated competencies in the following areas are required:
• Leadership in a professional and ethical manner
Technical writing skills
Posted By: Karli Minor
The Clinical Contract/Pricing Specialist will support the Business Strategy and Scientific Affairs Leaders by managing clinical trial and research-related contracts for multiple orthopedic programs. Collaborating closely with scientific/clinical affairs, project management, finance, compliance, procurement, and legal teams, this role is responsible for overseeing the development, negotiation, fair market value assessment, and execution of contracts (e.g., clinical trial agreements, confidentiality agreements, SOWs, amendments) with external partners, vendors, and investigative sites. This role ensures all contract activities are aligned with company and departmental policies, timelines, and budgetary requirements, and will utilize contract management systems (such as Icertis, eMarketplace, Totality, Gensight PMT, Sharepoint, and others) in support of these processes. The Clinical Contract/Pricing Specialist will be key to identifying and implementing process improvements and serving as a resource in resolving contractual, legal, and operational issues across partnering teams.
This individual will prepare, negotiate and finalize agreements and budgets related to clinical trials directly sponsored by the Company or through the Investigator Initiated/Collaborative Research Program. The Clinical Contract/Pricing Specialist will provide support to the clinical team in the pricing, planning, execution and control of site/investigator budgets and contracts.
The activities include drafting, implementing, monitoring, and evaluating compliance with company sponsored research and investigator initiated/collaborative research related to contractual requirements. Additional responsibilities may also include financial disclosures, sanction checks, conflict of interest activities, and Third-Party Intermediary due diligence.
SECTION 2: DUTIES & RESPONSIBILITIES*
• Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored, investigator-initiated/collaborative studies, and real-world evidence studies.
• Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate.
• Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and the Company pricing guidelines. Participate in and/or lead approval escalations as appropriate.
• Provide support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.
• Participate in discussions related to the development of site/investigator budgets aligned with fair market value.
• Track all aspects of legal documents and metrics. Determine potential needs for contract amendments and manage amendment lifecycle.
• Work proactively to provide recommendations to improve processes and procedures to establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial agreements.
• Provide support to review, authorize and/or understand aspects of site payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
• Adhere to SOPs, ethics and departmental compliance as determined by corporate, HCC and QA guidelines.
• If applicable, region specific deliverables will be specified.
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management according to expectations (metrics) and archiving retention requirements.
• Oversees the maintenance of an internal database for site-related costs and analyzes changes.
• Ensures the maintenance of accurate, project-specific financial working files.
• Provide internal communication of important contract status, changes in contract requirements/regulations and events.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Maintain electronic repository system and ensure all files are uploaded and current.
SECTION 3: EXPERIENCE AND EDUCATION*
Education
• Minimum of a Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, Biological Science, Finance, Business and/or Law.
Experience
• A minimum of 3 years of relevant experience (or equivalent) required.
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) required
• Experience in contracts management required and payment processing, HCC a plus.
• Previous clinical research or related technical experience and legal experience a plus
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
• Requires understanding of Good Clinical Practices
• Strong and proven negotiation and problem resolution skills.
• Understanding and application of regulations and standards applied in clinical areas/regions is required
• Good presentation skills and effectively influencing of others
• Written and oral communication skills
• Demonstrated competencies in the following areas are required:
• Leadership in a professional and ethical manner
Technical writing skills
Posted By: Karli Minor