About the role
Responsibilities Key Responsibilities Contract Preparation & Execution
- Draft, review, and coordinate DMC member agreements (e.g., confidentiality disclosure agreements, consulting agreements).
- Facilitate contract negotiation in collaboration with Legal and sponsors.
- Track contract status from initiation through execution.
- Ensure appropriate templates and approved language are used.
Financial & Payment Coordination
- Coordinate compensation terms and payment schedules for DMC members.
- Partner with Finance to ensure timely and accurate processing of invoices and honoraria.
- Track budgets related to DMC member compensation.
- Maintain payment documentation and audit trails.
Compliance & Documentation
- Ensure DMC member documentation is complete and up to date (CVs, financial disclosure forms, conflict-of-interest statements).
- Maintain inspection-ready contract files in document management systems.
- Ensure compliance with regulatory guidelines (FDA, EMA, ICH) and internal SOPs.
Cross-Functional Collaboration
- Partner with DMC project leads to align contract timelines with study milestones.
- Liaise with Legal regarding contract redlines and risk considerations.
- Coordinate with sponsors on contract-related requirements.
- Provide status updates and escalate delays or risks appropriately.
Process Improvement
- Contribute to development and refinement of contract templates and tracking tools.
- Support internal audits and quality improvement initiatives.
- Identify opportunities to streamline contracting workflows.
Qualifications QUALIFICATIONS Education
- Bachelor’s degree in business, legal studies, life sciences, or related field preferred.
Experience
- 5-8 years of experience in clinical research contracting, vendor management, or legal/contract administration, with familiarity with consulting agreements and DMC committees preferred.
- Experience working within a CRO or pharmaceutical environment preferred.
Skills & Competencies
- Strong understanding of contract lifecycle management.
- Excellent organizational and tracking skills.
- High attention to detail and accuracy.
- Ability to manage multiple agreements simultaneously.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office; experience with contract management systems preferred.
- High discretion and understanding of confidentiality requirements.
Key Attributes
- Detail-oriented and process-driven.
- Strong sense of accountability.
- Collaborative and solutions-focused.
- Comfortable working in a compliance-heavy environment.
About Cytel
Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.
Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.
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About the role
Responsibilities Key Responsibilities Contract Preparation & Execution
- Draft, review, and coordinate DMC member agreements (e.g., confidentiality disclosure agreements, consulting agreements).
- Facilitate contract negotiation in collaboration with Legal and sponsors.
- Track contract status from initiation through execution.
- Ensure appropriate templates and approved language are used.
Financial & Payment Coordination
- Coordinate compensation terms and payment schedules for DMC members.
- Partner with Finance to ensure timely and accurate processing of invoices and honoraria.
- Track budgets related to DMC member compensation.
- Maintain payment documentation and audit trails.
Compliance & Documentation
- Ensure DMC member documentation is complete and up to date (CVs, financial disclosure forms, conflict-of-interest statements).
- Maintain inspection-ready contract files in document management systems.
- Ensure compliance with regulatory guidelines (FDA, EMA, ICH) and internal SOPs.
Cross-Functional Collaboration
- Partner with DMC project leads to align contract timelines with study milestones.
- Liaise with Legal regarding contract redlines and risk considerations.
- Coordinate with sponsors on contract-related requirements.
- Provide status updates and escalate delays or risks appropriately.
Process Improvement
- Contribute to development and refinement of contract templates and tracking tools.
- Support internal audits and quality improvement initiatives.
- Identify opportunities to streamline contracting workflows.
Qualifications QUALIFICATIONS Education
- Bachelor’s degree in business, legal studies, life sciences, or related field preferred.
Experience
- 5-8 years of experience in clinical research contracting, vendor management, or legal/contract administration, with familiarity with consulting agreements and DMC committees preferred.
- Experience working within a CRO or pharmaceutical environment preferred.
Skills & Competencies
- Strong understanding of contract lifecycle management.
- Excellent organizational and tracking skills.
- High attention to detail and accuracy.
- Ability to manage multiple agreements simultaneously.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office; experience with contract management systems preferred.
- High discretion and understanding of confidentiality requirements.
Key Attributes
- Detail-oriented and process-driven.
- Strong sense of accountability.
- Collaborative and solutions-focused.
- Comfortable working in a compliance-heavy environment.
About Cytel
Cytel is the world’s leading data-science CRO, driving advancements in human health through robust analytics and innovative clinical trial software. For nearly four decades, we have set the standard in adaptive trial design, leveraging extensive data insights to inform strategy throughout every phase of drug development and commercialization. Our mission is clear: accelerate drug development, enhance success rates, and deliver better patient outcomes. With a comprehensive suite of services from innovative trial design to end-to-end biometrics and real-world evidence, our specialized, multidisciplinary team ensures optimal strategies for preclinical research, trial execution, market access, and reimbursement.
Headquartered in Cambridge, Massachusetts, Cytel has a global presence with over 2,000 employees across North America, Europe, and Asia. Learn more about how Cytel is harnessing the power of data to advance human health at www.cytel.com.