Site Contract Manager

Overview

This remote role is available in all states within the United States of America. While Titusville, New Jersey, United States of America is listed as a reference location, it does not limit where you can apply.

The organization is seeking an Associate Site Contract Manager to support clinical trial contract and budget preparation, negotiation, and finalization.

Responsibilities

• Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies through direct negotiation with clinical trial sites or via oversight of a Clinical Research Organization responsible for contract negotiations.
• Support negotiations for confidentiality agreements, informed consent forms, and other ancillary contract documents as required.
• Participate in discussions related to development of site/investigator budgets aligned with fair market value.
• Manage the contract amendment lifecycle.
• Maintain responsibility for legal document and metrics tracking.
• Support review, authorization, and/or understanding of site payments; assist clinical operations or the clinical team to ensure that investigator grants comply with overall study costs and compliance guidelines.
• Comply with requests from QA and auditors.
• Provide recommendations to improve processes and implement refinements that reduce cycle time, create savings, and improve efficiency in the initiation of clinical trial sites.
• Work with the global CCS team as necessary to review and analyze contractual terms to reach resolution; assess risks related to budget and legal provisions in conjunction with CCS team members and support functions; escalate issues as appropriate.
• Demonstrate exemplary customer focus and a vision to drive solutions.

Requirements

• Bachelor’s degree with 3+ years experience and/or equivalent competencies in pharmaceutical industry/clinical research; must have a working knowledge of the clinical development process.
• 2+ years’ experience with negotiation and contracts.
• Demonstrated AI literacy and an AI enabled mindset, including the ability to apply AI tools responsibly in daily work to improve productivity, decision making, and quality of outcomes.
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus.
• Familiarity with clinical research processes.
• Ability to work effectively in cross-functional teams.
• Strong and proven negotiation and problem resolution skills.
• Working knowledge of PCs (MS Office suite at a minimum) and database management.
• Must demonstrate innovative spirit, have strong interpersonal skills, and ability to manage a high volume of work.
• Previous experience working in virtual teams preferred.

Preferred Skills

• Analytical Reasoning, Analytics Dashboards, Business Behavior, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials, Execution Focus, Laboratory Operations, Medical Knowledge, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics, Training Administration

Compensation & Benefits

Anticipated base pay range

• $76,000.00 - $121,900.00

Retirement and savings plan

Subject to the terms of their respective plans, employees are eligible to participate in the organization’s consolidated retirement plan (pension) and savings plan (401(k)).

Time off and other benefits (subject to applicable policies and date of hire)

• Vacation – 120 hours per calendar year
• Sick time – 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
• Holiday pay, including Floating Holidays – 13 days per calendar year
• Work, Personal and Family Time – up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period (10 days)
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

Location

• Titusville, New Jersey, United States of America (reference)
• Remote role available in all states within the United States of America