Senior Site Contract Manager

Columbus, OH, United States

J&J Family of Companies Senior Site Contract Manager Columbus , Ohio Apply Now Description

Johnson & Johnson Innovative Medicine, Global Clinical Operations, Contracts and Compliance Service Department is recruiting for a Senior Site Contract Manager, located in United States.

Responsible for the development and analysis of contractual relationships including investigator grants including but not limited to drafting, negotiating, and finalizing agreements related to clinical trials and/or overseeing a Clinical Research Organization responsible for contract negotiations. Provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.

Key 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 oversite of a Clinical Research Organization responsible for contract negotiations.

Responsible for delivery on established targets/measurements. Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.

Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required.

Analyze investigator grants for fair market value aligned with regional knowledge and the J&J grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate.

Work with the global CCS team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. Assess risks of budget and legal provisions in conjunction with members of the CCS team and support functions and communicate such to stakeholders. Liaise with CCS management and functional CCS support teams, legal, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.

Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites. Mentor and train new contract coordinators and analysts.

Assume responsibility for all aspects of legal document and metrics tracking. Determine potential needs for contract amendments and manage amendment lifecycle.

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

Qualifications

Education:

Bachelor’s degree in appropriate scientific or business disciplines

Experience and Skills:

Required:

3 to 5 years-experience and/or equivalent competencies in pharmaceutical industry/clinical research

Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus

Must have a working knowledge of the clinical development process with two (2) years of negotiation and contract experience

Familiarity with clinical research processes

Ability to work effectively in cross function 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

Preferred:

Previous experience working in virtual teams' environment preferred.

Experience with coordination and overseeing project work of Contract Research Organization

Other:

Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, Health Care Compliance and Quality Assurance guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with CCS, GD and operating companies. Comply with requests from QA and auditors.

Able to work independently as well as in a collaborative team environment.

Fluency in English required.

Travel Percentage: 10%

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $101,000-$162,725

The anticipated compensation for this role in all other U.S. locations is $88,000-$141,450

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

Vacation - up to 120 hours per calendar year

Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

Holiday pay, including Floating Holidays - up to 13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on May 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location NA-US-New Jersey-Titusville

Other Locations NA-United States

Job Function Clinical Trial Project Management

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