Beschreibung
Job Summary
The Site Contracts, Budgets & Payments (SCB&P) Specialist is responsible for executing and coordinating site contract, site budget development/escalations, and/or payment activities throughout the clinical trial lifecycle, from feasibility through study closeout and post-study activities, as required. Depending on business needs and assigned responsibilities, the SCB&P Specialist may support site contracting and budget activities, site payment activities, or a combination of these functions.
The Specialist serves as a key point of contact for assigned countries/regions, Study Start-Up Managers (SSMs), Clinical Operations, Legal, Finance, Procurement, and external sites to facilitate the timely preparation, negotiation, execution, maintenance, and tracking of assigned activities. The role collaborates with cross-functional stakeholders to support contract lifecycle activities, budget development and negotiation, and/or payment operations while ensuring compliance with corporate policies, applicable regulations, and study timelines.
Duties and Responsibilities
- Execute and coordinate assigned site contract, budget, and/or payment activities throughout the clinical trial lifecycle.
- Prepare, coordinate, and support negotiation of Clinical Trial Agreements (CTAs), Confidential Disclosure Agreements (CDAs), Letters of Indemnification, budget amendments, and other site-related agreements, as assigned.
- Prepare, develop, and negotiate site budgets using approved negotiation strategies and country-specific requirements, as assigned.
- Evaluate and respond to Site budget escalations as needed.
- Coordinate investigator/site payment activities, monitor payment status, investigate payment inquiries, and support timely resolution of payment issues and escalations, as assigned.
- Maintain contract, budget, and/or payment records within applicable business systems.
- Monitor assigned milestones, identify risks or delays, and escalate issues as appropriate.
- Participate in implementation, testing, validation, and user adoption activities for contract lifecycle management, budget, and payment systems.
- Maintain operational reports, dashboards, and key performance indicators (KPIs) supporting assigned responsibilities.
- Verify that assigned activities are completed in accordance with applicable SOPs, corporate policies, GCP, financial controls, and regulatory requirements.
- Collaborate with Clinical Operations, Legal, Finance, Procurement, Privacy, Information Technology, and external stakeholders to resolve contract, budget, and/or payment issues.
- Maintain complete and accurate documentation to support inspection readiness and audit requirements.
- Identify opportunities for process improvements and participate in initiatives that improve operational efficiency across site contracts, budgets, and payments.
- Perform other duties as assigned.
Qualifications (Minimal acceptable level of education, work experience, and competency)
- Preferred Bachelor’s Degree in Business Administration, science or related field (e.g., Juris Doctor), or additional relevant experience
- Minimum of three years of combined experience in site contracts and/or payments, with at least three years of active involvement in international or global operations
- Flexibility to assume a workload, which frequently necessitates an adjustment of priorities
- Goal oriented, self-starter with proven ability to work independently
- Able to proactively identify issues and provide potential solutions for resolution
- Detail oriented
- Ability to manage multiple tasks simultaneously and meet deliverables in accordance with stated timelines
- High proficiency with ICE360, Veeva Vault and all applications of Microsoft Office
- Good interpersonal skills
- Comfort with ambiguity; ability to act without having the total picture
- Excellent oral and written communication skills in English and other local language(s) as applicable
- Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures
Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].