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Lead Site Contract Manager - job post

Johnson & Johnson
4.2 out of 5
Stockholm
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Ort

Stockholm

Fullständig jobbeskrivning

Lead Site Contract Manager

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 https://www.jnj.com/

We have an exciting opportunity for a Lead Site Contract Manager, located within commutable distance of our site in Stockholm, Sweden to join our team.

The Lead Site Contract Manager, reporting to the Manager, Site Contracting, plays a pivotal role in the development and analysis of site contracts for clinical trials. Responsibilities include drafting, negotiating, and finalizing agreements, as well as overseeing a Clinical Research Organization's contract negotiations. The lead provides essential training to staff, facilitates clear communication, and aids Analysts in resolving contracting and study-related issues. Additionally, the lead offers project management and oversight to internal and external stakeholders, supporting the clinical team in pricing, planning, execution, and contract control. In essence, the Lead Site Contract Manager is instrumental in ensuring the efficiency of contracting processes and the success of clinical trials.

Principal Responsibilities:

  • Lead the preparation, negotiation, and finalization of clinical trial agreements and ancillary agreements for both company-sponsored and investigator-initiated studies. Directly engage in negotiations with clinical trial sites or oversee a Clinical Research Organization handling contract negotiations.
  • Analyze requirements and translate them into appropriate contracts and budgets for clinical trial agreements and other relevant legal documents. Review study-specific tracking requirements for accuracy and completeness, ensuring adherence to contracting cycle time targets.
  • Collaborate with global teams to review and analyze contractual terms and conditions, assessing legal and budget risks in conjunction with support functions. Partner with stakeholders such as Healthcare Compliance, Risk Management, and Privacy to obtain guidance and drive resolution. Evaluate investigator fees for fair market value pricing and alignment with regional standards and company guidelines. Participate in or lead approval escalations as needed.
  • 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 entire amendment lifecycle, ensuring compliance with corporate processes, systems, and strategies.
  • Offer project management oversight to Contract Research Organizations (CROs) contracted for global clinical trial agreement negotiations. This includes training and supervision to ensure strict adherence to timelines and targets.
  • Onboard and train new staff, conducting regular meetings with team members to ensure proper study support and identify and resolve contracting issues. Assist in the resolution of site/study-related concerns.
  • Mentor and guide teams on processes and procedures, serving as a key liaison with management for staff performance and development. Facilitate clear and consistent communications between management and team members.
  • Identify and implement process improvements to enhance efficiency. Drive accountability and results throughout the contracting process.
  • May assist in the review, authorization, and/or management of payments. Support clinical operations or the clinical team in ensuring investigator grants comply with overall study costs and compliance guidelines.
  • Exhibit exemplary customer focus with a vision to drive solutions.

Qualifications

Education and Experience Requirements:

  • Bachelor’s degree in appropriate scientific or business disciplines is required!
  • 3 to 5 years-experience and/or equivalent competencies in 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
  • Effective collaboration in cross-functional teams
  • Proven initiative, innovative spirit, strong interpersonal skills and self-starter capability
  • Strong negotiation and problem-solving skills
  • Working knowledge of PC and database management (MS Office suite at a minimum)
  • Ability to accomplish substantial tasks with minimal supervision
  • Preferred experience in working with virtual teams
  • Independence in work and collaborative team capability
  • Fluency in English required
  • 10% travel expected

Benefits:

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organization.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

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