This job has expired on Bestjobs.jp
Reasons could include the position has been filled or the company is not accepting new applicants.
(Janssen) R&D, Lead Site Contract Manager, Contract and Centralized Services
Position Summary:
Responsible for the development and analysis of site contracts 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. The lead will assist with training of staff, facilitating clear and concise communications and assist Analysts with resolution of contracting and study related issues. In addition, the lead will provide project management and oversight to internal and external stakeholders as required and support to the clinical team in the pricing, planning, execution and control of 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.
• Responsible for analyzing requirements and translating into appropriate contracts and budgets for clinical trial agreements and other relevant legal documents. Responsible for reviewing all study specific tracking requirements for accuracy and completeness as well as delivering 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 the 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, as required. Determine potential needs for contract amendments and manage amendment lifecycle. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies
Provide project management oversight to CROs contracted to negotiate CTAs globally, inclusive of training and supervision to ensure adherence to timelines/targets.
• Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in 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 andconsistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results.
• May assist in review, authorization and/or management of payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
• 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.
Principal Relationships:
This position reports to Manager, Site Contracting.
Internal:
• Internal Business Partners (CCS, TA, MAF, MAO, GD, HCC, Risk Management, Legal, etc.) outside parties
External:
• Clinical Investigator Sites
• Commercial Suppliers
• Clinical Research Organizations (when applicable).Education and Experience Requirements:
• Bachelor's degree in appropriate scientific or business disciplines
• 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
• 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
• Previous experience working in virtual teams preferred
DECISION-MAKING AND PROBLEM-SOLVING:
• Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA 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.
• Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in 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.
• Able to work independently as well as in a collaborative team environment.
Other:
• Fluency in English required.
• Travel Percentage: 10%
Responsible for the development and analysis of site contracts 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. The lead will assist with training of staff, facilitating clear and concise communications and assist Analysts with resolution of contracting and study related issues. In addition, the lead will provide project management and oversight to internal and external stakeholders as required and support to the clinical team in the pricing, planning, execution and control of 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.
• Responsible for analyzing requirements and translating into appropriate contracts and budgets for clinical trial agreements and other relevant legal documents. Responsible for reviewing all study specific tracking requirements for accuracy and completeness as well as delivering 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 the 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, as required. Determine potential needs for contract amendments and manage amendment lifecycle. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies
Provide project management oversight to CROs contracted to negotiate CTAs globally, inclusive of training and supervision to ensure adherence to timelines/targets.
• Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in 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 andconsistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results.
• May assist in review, authorization and/or management of payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
• 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.
Principal Relationships:
This position reports to Manager, Site Contracting.
Internal:
• Internal Business Partners (CCS, TA, MAF, MAO, GD, HCC, Risk Management, Legal, etc.) outside parties
External:
• Clinical Investigator Sites
• Commercial Suppliers
• Clinical Research Organizations (when applicable).Education and Experience Requirements:
• Bachelor's degree in appropriate scientific or business disciplines
• 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
• 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
• Previous experience working in virtual teams preferred
DECISION-MAKING AND PROBLEM-SOLVING:
• Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as operating companies, corporate, HCC and QA 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.
• Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in 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.
• Able to work independently as well as in a collaborative team environment.
Other:
• Fluency in English required.
• Travel Percentage: 10%
