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R&D Operations

China Site Contracting Manager

  • Titolo China Site Contracting Manager
  • Funzione R&D Operations
  • Sottofunzione Clinical Trial Project Management
  • Categoria Manager, Clinical Trial Project Management (P7)
  • Località Shanghai, China
  • Data di pubblicazione
  • Riferimento 2406195704W
Fai Domanda Ora
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Descrizione

CCS function. Assist management in the efficient execution of the contracts and grants processes and in meeting strategic objectives.
Principal Responsibilities:
• Serve as a subject matter expert for all issues relating to contracts and grants department processes and corporate/GD policies and procedures as they relate to CCS functions.
• Lead business partner communications and strategy intelligence for all trials and leadership team reporting of metrics and key performance indicators
• Lead recruiting, training, managing, coaching/mentoring, workload prioritizing, and evaluating staff members. Contribute to ensuring optimum utilization of resources and compliance with project deadlines. Execute strong supplier relationship management with flex providers and institutions and drive empowerment.
• Work closely with global stakeholders: establish and maintain working relationships with J&J business partners, health care compliance, risk management, J&J legal, insurance broker(s), privacy, suppliers, customers and other identified stakeholders.
• Continuously work to refine GD contracts and grants processes in alignment with stakeholder needs and in compliance with corporate process, systems, and strategies by identifying innovative process improvements, determining feasibility, and collaborating with appropriate parties to implement when appropriate.
• Work proactively to increase global awareness of group processes and procedures and train and educate stakeholders.
• Assume primary responsibility for tracking, maintenance and accuracy of metrics, contract documents, and supporting documentation.
• Act as subject matter expert of regional requirements, practices and regulations as they relate to clinical contracts and grants. Contribute to building a knowledge management system of global requirements for contracts and grants functions.
• Responsible for analyzing contract requests/needs from operating companies and proactively translating into appropriate clinical contracts/budgets. Lead negotiation and execution of agreements including specialized support for negotiations in confidentiality agreements, informed consent forms, amendments and other ancillary contract documents as required.
• Analyze investigator grants for fair market value aligned with regional knowledge, compliance guidance and the J&J grant pricing guidelines. Lead the approval escalation of grants as appropriate
• Manage CROs contracted to negotiate CTAs globally, inclusive of training and supervision.
• Responsible for assessing risks of budget and legal provisions independently. Provide solution and business focused advice to stakeholders and others within J&J on contract and grant related topics
• Establish master agreements, lean process enhancements and other innovative solutions to expedite site initiation
• Review, authorize and/or manage payments where appropriate. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.
Principal Relationships:
This position reports to Senior Manager, Site Contracting
Internal:
• Internal Business Partners (CCS, TA, MAF, MAO, GD, HCC, Risk Management, Legal, etc.)
External:
• Clinical Investigator Sites
• Commercial Suppliers
• Clinical Research Organizations (when applicable).

Qualifiche

spirit, strong interpersonal and leadership skills and complex project management
• Must be able to handle high volume of work and meet very aggressive deadlines
• Knowledge of databases and/or project management systems is a plus
• Flexibility to manage through ambiguity with minimal direction and motivate team members a must
• Excellent communication skills required
• Previous work in international and virtual environments desirable
• Previous people management experience preferred
• Understanding of healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
• Experience in project management and/or logistics is mandatory
• Must demonstrate innovative spirit, strong interpersonal and leadership skills and complex project management
• Must be able to handle high volume of work and meet very aggressive deadlines
• Previous work in international and virtual environments desirable
• Previous people management experience preferred
• Exemplary customer focus with vision to drive solutions
DECISION-MAKING AND PROBLEM-SOLVING
• Continuously work to refine GD contracts and grants processes in alignment with stakeholder needs and in compliance with corporate process, systems, and strategies by identifying innovative process improvements, determining feasibility, and collaborating with appropriate parties to implement when appropriate.
• Responsible for assessing risks of budget and legal provisions independently. Provide solution and business focused advice to stakeholders and others within J&J on contract and grant related topics.
• Assist in recruiting, training, managing, coaching/mentoring, workload prioritizing, and evaluating staff members. Contribute to ensuring optimum utilization of resources and compliance with project deadlines. Leverage expertise & efficiencies in clinical site contracting across therapeutic areas, recognize opportunities for enhancements, identify and implement solutions.
Other:
• Fluency in English required.
• Travel Percentage: 10%

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