Responsible for the development and analysis of fair market value pricing for clinical trial agreements including benchmarking fees and drafting and finalizing financial exhibits to clinical trial agreements. The lead will assist with training of staff, facilitating clear and concise communications and assist PAs with resolution of pricing, contracting and study related issues. In addition, the Pricing lead will provide project management and oversight to internal and external stakeholders as required and support to the clinical team in the budgeting, pricing, planning, execution and control of contracts.
- Analyze requirements and translate into appropriate pricing, budgets and contracts for clinical trial agreements and other relevant legal documents.
- Review all study specific tracking requirements for accuracy and completeness as well as delivering against pricing cycle time targets
- Analyze investigator grants for fair market value aligned with regional knowledge and the J&J pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information.
- Provide specialized support and guidance on negotiations in clinical trial agreements, informed consent forms and other ancillary contract documents, as required.
- Translate clinical trial protocol requirements into fair market value pricing/budget milestones.
- Determine potential needs for budget revisions and related contract amendments and manage the amendment pricing lifecycle. Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
- Provide guidance to CROs contracted to negotiate CTAs globally, inclusive of training and supervision to ensure adherence to timelines/targets.
- Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
- Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify 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.
- This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.
- Bachelor’s degree in appropriate scientific or business disciplines
- 5 years experience and/or equivalent competencies in pharmaceutical industry/clinical research
- Must have a working knowledge of the clinical development process with pricing/budgeting or negotiation and contract experience
- Must have experience working in IMS GrantPlan system or Medidata Grants Manager system
- Excellent communication skills (both oral and written)
- Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.)
- 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
- Advanced fluency in English is required
- Must demonstrate ability to work in a fast-paced environment and to work independently
- Previous experience working in virtual teams preferred
Johnson & Johnson Sdn. Bhd. (8275)