[Hiring] Site Contract Manager @Johnson & Johnson Innovative Medicine

Role Description

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

This is a remote role available in all states within the United States of America. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

We are searching for the best talent for Associate Site Contract Manager .

Purpose:

The Associate Site Contract Manager is responsible for preparing, negotiating, and finalizing agreements and budgets related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. They will provide support to the clinical team in the pricing, planning, execution, and control of site/investigator budgets and contracts.

You will be responsible for:

• 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.
• 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.
• Manage the contract amendment lifecycle.
• Assume responsibility for all aspects of legal document and metrics tracking.
• 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.
• Comply with requests from QA and auditors.
• Work proactively to provide recommendations to improve processes and establish 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 of budget and legal provisions in conjunction with members of the CCS team and support functions. Escalate issues as appropriate.
• Exemplary customer focus with vision to drive solutions.

This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.

Qualifications

• 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.

Requirements

• 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

Benefits

• 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
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year