Sr. Clinical Site Contracts Specialist

Dawn Recruiting Agency; New Jersey; On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Life insurance

AD&D insurance

Disability insurance

Paid time off

Sick leave

Tuition reimbursement

Fitness reimbursement

Employee assistance

Job summary

Dawn Recruiting Agency seeks a Senior Site Contracts Specialist to support clinical trial operations through effective contract negotiation, site budget management, and agreement execution. Based in New Jersey (USA), you will independently manage CTAs, site budgets, and related documents, collaborating with investigative sites, sponsors, and cross-functional study teams to ensure timely activation.

You will review budgets, negotiate FMV, improve contracting processes, and mentor junior staff

Qualifications

• Bachelor's degree or international equivalent in a relevant field, such as science, biology, English, or communications. A master's degree or Juris Doctor (JD) is preferred.
• At least 3 years of investigative site contracting experience, including hands-on experience with contract legal language and clinical trial budgets.
• Demonstrated experience negotiating and managing clinical trial agreements and associated site budgets.
• Strong understanding of contract review, budget negotiation, risk identification, and agreement execution.
• Excellent written and verbal communication skills, with the ability to collaborate effectively with investigative sites, sponsors, and internal teams.
• Strong organizational skills, attention to detail, and the ability to manage multiple studies and competing deadlines.
• Experience supporting quality control, process improvement, or junior staff development is an advantage.

Responsibilities

• Lead the negotiation, execution, and ongoing management of Clinical Trial Agreements with investigative sites across the United States and Canada, with international negotiations as needed.
• Negotiate study‑specific Confidential Disclosure Agreements (CDAs), CTAs, amendments, and other related contractual documents in accordance with client requirements and escalation procedures.
• Review site budget templates for accuracy against study protocols and identify potential negotiation challenges.
• Evaluate site budget requests, identify non‑applicable items, and negotiate fees in line with fair market value (FMV) and study requirements.
• Review contracts for completeness, accuracy, consistency, formatting, and professional presentation.
• Support the development and review of contract templates and training materials for new studies.

Skills

Contract negotiation

Budget management

Clinical trial knowledge

Regulatory/compliance

Stakeholder collaboration

Education

Bachelor's degree or international equivalent

Master's degree or JD preferred

Job description

Our client, a well-established Contract Research Organization (CRO), is seeking an experienced Senior Site Contracts Specialist to support clinical trial operations through effective contract negotiation, site budget management, and agreement execution.

This role is responsible for independently managing Clinical Trial Agreements (CTAs), associated site budgets, and related contractual documentation to support timely clinical study startup. The successful candidate will collaborate with investigative sites, sponsors, and cross‑functional study teams while helping maintain quality standards, manage risks, and improve contracting processes.

Key Responsibilities

• Lead the negotiation, execution, and ongoing management of Clinical Trial Agreements with investigative sites across the United States and Canada, with international negotiations as needed.
• Negotiate study‑specific Confidential Disclosure Agreements (CDAs), CTAs, amendments, and other related contractual documents in accordance with client requirements and escalation procedures.
• Review site budget templates for accuracy against study protocols and identify potential negotiation challenges.
• Evaluate site budget requests, identify non‑applicable items, and negotiate fees in line with fair market value (FMV) and study requirements.
• Review contracts for completeness, accuracy, consistency, formatting, and professional presentation.
• Support the development and review of contract templates and training materials for new studies.
• Maintain accurate records of site communications, negotiation progress, and client status updates.
• Track contract negotiation timelines, forecast execution milestones, and proactively address potential delays.
• Collaborate with Clinical Operations, Project Management, Site Contract Managers, and other stakeholders to support timely site activation.
• Identify and elevate contractual, budgetary, and operational risks before they affect study timelines.
• Provide guidance and mentorship to junior team members and contribute to quality control initiatives.
• Support process improvements within the site contracts function.
• Identify out‑of‑scope activities, including additional requests, timeline changes, or newly added sites, and coordinate the preparation of change orders as required.
• Manage shifting priorities effectively in a fast‑paced clinical research environment and support studies across multiple therapeutic areas.

Qualifications and Experience

• Bachelor's degree or international equivalent in a relevant field, such as science, biology, English, or communications. A master's degree or Juris Doctor (JD) is preferred.
• At least 3 years of investigative site contracting experience, including hands‑on experience with contract legal language and clinical trial budgets.
• Demonstrated experience negotiating and managing clinical trial agreements and associated site budgets.
• Strong understanding of contract review, budget negotiation, risk identification, and agreement execution.
• Excellent written and verbal communication skills, with the ability to collaborate effectively with investigative sites, sponsors, and internal teams.
• Strong organizational skills, attention to detail, and the ability to manage multiple studies and competing deadlines.
• Experience supporting quality control, process improvement, or junior staff development is an advantage.
• Medical, dental, and vision insurance
• Life and AD&D insurance
• Short- and long‑term disability coverage
• Paid time off and sick leave
• Tuition and fitness reimbursement
• Employee assistance program
• Performance‑based bonus opportunities