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R&D Operations

Senior Site Contract Manager, Global Site Contracting - Oncology (1 of 2)

  • Titel Senior Site Contract Manager, Global Site Contracting - Oncology (1 of 2)
  • Funktion R&D Operations
  • Unterfunktion Clinical Trial Project Management
  • Kategorie Experienced Analyst, Clinical Trial Project Management (P5)
  • Standort Titusville, New Jersey, United States
  • Gepostet
  • [Close Date]
  • Stellenangebotsnummer 2406176870W
Bewerben
Freigeben

This job posting is anticipated to close on Apr 20 2024. The Company may however extend this time-period, in which case the posting will remain available on www.careers.jnj.com to accept additional applications.

Beschreibung

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Site Contract Manager, Global Site Contracting - Oncology.  This position can be located at any Janssen site within the United States.  Remote work options may be considered on a case-by-case basis and if approved by the company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives.  We focus on treating, curing and preventing some of the most devastating and complex diseases of our time.  And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension.  Please visit http://www.janssenrnd.com for more information.

The Senior Site Contract Manager will be 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 (CRO) responsible for contract negotiations.  This individual will provide support to the clinical team in the pricing, planning, execution and control of grants and contracts.

Principal 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.
  • Deliver on established targets/measurements.  Analyze 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 Johnson & Johnson 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 Contract and Centralized Services (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.

Befähigungen

  • A minimum of a Bachelor’s degree is required, preferably in a Scientific or Business discipline.
  • A minimum of 3 years of contract experience in clinical operations with a Pharmaceutical company, Contract Research Organization (CRO) or investigator site is required.
  • Knowledge of healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) is preferred.
  • Experience in the Oncology Therapeutic Area is preferred.
  • Knowledge of the clinical/drug development process is required.
  • Knowledge of the clinical research process is preferred.
  • Experience in project management and/or logistics is preferred.
  • Knowledge of databases and/or project management systems preferred.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
  • Previous work experience in international and virtual environments preferred.
  • Must have excellent communication and interpersonal skills.
  • Must have strong negotiation, decision-making and problem-solving skills.
  • Must have the flexibility to manage through ambiguity with minimal direction and motivate team members.
  • The ability to handle a high volume of work and meet very aggressive deadlines is required.
  • The ability to collaborate with all levels in a cross-functional team environment is required.
  • This position will require up to 10% travel (meetings, training, etc.).

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

The anticipated base pay range for this position in all other U.S. locations is $88,000 to $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

This job posting is anticipated to close on April 12, 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.

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