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About the Role

Responsible for the development and analysis of site contracts, including drafting, negotiating, and finalizing agreements related to clinical trials. This role involves overseeing Clinical Research Organizations responsible for contract negotiations, training staff, facilitating communication, and resolving contracting issues. The lead will provide project management and oversight to internal and external stakeholders, supporting pricing, planning, execution, and control of contracts.

Responsibilities

Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company-sponsored and/or investigator-initiated studies.
Analyze requirements and translate them into appropriate contracts and budgets for clinical trial agreements and other relevant legal documents.
Review all study-specific tracking requirements for accuracy and completeness, and deliver against contracting cycle time targets.
Work with global teams to review and analyze contractual terms and conditions.
Assess legal and budget risks in conjunction with team support functions.
Partner with Healthcare Compliance, Risk Management, Privacy, and other stakeholders to obtain guidance and drive resolution.
Analyze investigator fees in relation to fair market value pricing and ensure alignment with regional standards and J&J pricing guidelines.
Participate in and/or lead approval escalations as appropriate.
Provide specialized support and guidance on negotiations in confidentiality agreements, informed consent forms, and other ancillary contract documents.
Determine potential needs for contract amendments and manage the amendment lifecycle.
Ensure that contractual terms and provisions comply with corporate processes, systems, and strategies.
Provide project management oversight to CROs contracted to negotiate CTAs globally, including training and supervision.
Onboard and train new staff, meet regularly with team members to ensure studies are properly supported, and identify contracting issues and potential solutions.
Assist in the resolution of site/study-related concerns.
Mentor and guide teams on processes and procedures.
Serve as a key liaison with management on staff performance and development.
Facilitate clear and consistent communications between management and other team members.
Identify and implement process improvements.
Drive accountability and results.
May assist in the review, authorization, and/or management of payments.
Assist clinical operations or clinical teams in ensuring that investigator grants comply with overall study costs and compliance guidelines.
Adhere to SOPs, ethics, and departmental compliance.
Ensure familiarity with departmental and corporate processes.
Comply with requests from QA and auditors.
Able to work independently as well as in a collaborative team environment.

Requirements

Bachelor’s degree in appropriate scientific or business disciplines
3 to 5 years of experience and/or equivalent competencies in the pharmaceutical industry/clinical research
Must have a working knowledge of the clinical development process with 2 years of negotiation and contract experience
Excellent communication skills (both oral and written)
Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
Comprehensive knowledge of clinical research processes
Ability to work effectively in cross-functional teams
Strong initiative and proven self-starter
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 accomplish substantial tasks with minimal supervision
Previous experience working in virtual teams preferred
Fluency in English required

Skills

Analytical Reasoning
Clinical Research and Regulations
Clinical Trial Designs
Clinical Trial Management Systems (CTMS)
Clinical Trials
Communication
Data Savvy
Laboratory Operations
Organizing
Problem Solving
Productivity Planning
Professional Ethics
Project Integration Management
Quality Assurance (QA)
Regulatory Compliance
Research and Development
Research Ethics
Standard Operating Procedure (SOP)

Location

Chiyoda, Tokyo, Japan

Work Type

Full-time

Experience Level

3 to 5 years

Education Level

Bachelor's degree

About the Company

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.