POSITION SUMMARY :
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.
Provide support to the clinical team in the budgeting, pricing, planning, execution and control of grants and contracts.
PRINCIPAL RESPONSIBILITIES :
Analyze pricing requests / needs from operating companies and translating into appropriate budgets / contract exhibits for company sponsored and investigator initiated clinical trial agreements and other ancillary contract documents as they relate to various clinical projects.
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.
Participate in and / or lead the budget escalation review process
Translate clinical trial protocol requirements into fair market value pricing / budget milestones per company guidelines and policy.
Provide guidance to CROs contracted to negotiate CTAs globally, inclusive of training and supervision.
Determine potential needs for budget revisions and related contract amendments.
Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
Provide virtual training to global clinical trial agreement negotiators.
Assume responsibility for all aspects of pricing documentation and metrics tracking.
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 pricing assistants, pricing analysts, and contract analysts as needed.
This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.
DECISION-MAKING AND PROBLEM-SOLVING :
Adhere to SOPs, ethics and departmental compliance as determined by department 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 C&G, department and operating companies
Comply with requests from QA and auditors
EDUCATION & EXPERIENCE REQUIREMENTS :
Bachelor’s degree, or equivalent, in appropriate scientific or business disciplines
3-5 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 pricing / budgeting or negotiation and contract experience
Fluency in English & Japanese is required
Excellent communication skills (both oral and written)
Experience working with IMS GrantPlan system or Medidata Grants Manager system is preferred
Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.
Ability to work effectively in cross function teams in various levels of the organization
Strong and proven negotiation and problem resolution skills
Must demonstrate ability to work in a fast paced environment and to work independently
Working knowledge of PCs (MS Office suite at a minimum) and database management
Previous experience working in virtual teams preferred