• Serve as a subject matter expert for all issues relating to contracts and grants department processes and corporate/procurement/GCDO policies and procedures as they relate to contracts and grants 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. 20 % 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 20 % management, J&J legal, insurance broker(s), privacy, suppliers, customers, and other identified stakeholders.
• Continuously work to refine GCDO contracts and grants processes in 10 % alignment with stakeholder needs and in compliance with corporate processes, 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 on 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 them 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 and tasks. Other duties may be performed as assigned.
• Travel: Minimum travel required. ·The ability to travel up to 10% of the time.
DECISION-MAKING AND PROBLEM-SOLVING:
• Identify and promote best practices. Adhere to SOPs, ethics, and departmental compliance as determined by GCDO management, Procurement as well as operating companies, corporate, HCC, and QA guidelines, and auditors.
• Assure that contract and budget provisions are in compliance with corporate processes, systems, and strategies. Liaise with the global C&G team, J&J Corporate Law, Local Legal Counsel, CDO Colleagues, Healthcare Compliance, Risk Management, Privacy, and other stakeholders to escalate and resolve issues as appropriate.
• 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.
• Bachelor's degree or equivalent in appropriate scientific or business disciplines, master’s degree, and/or MBA preferred.
• At least 6 years of experience in clinical trial operations. At least 3 years’ experience in clinical trial investigator contracting, budgeting, and negotiation.
• Understanding of healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
• Fluency in English required.
• Experience in project management and/or logistics is mandatory.
• Working knowledge of MS Office suite at a minimum, knowledge of databases and/or project management systems is a plus
• Must demonstrate innovative spirit, strong interpersonal and leadership skills, and complex project management.
• Must be able to handle a high volume of work and meet very aggressive deadlines
• Previous work in international and virtual environments desirable
• Previous people management experience preferred.