Pricing and Contract Strategy Manager

Responsibilities:

• Excellent employment opportunity for a Pricing and Contract Strategy Manager in the Wilmington, DE area. Local to Wilmington: HYBRID (3 days onsite/2 days remote)
• Study Contract Manager (SCM) play an important role in driving the costings and contracts being responsible for negotiation and budgeting in clinical trials and for developing and managing contracts and annexes with investigators and institutions or external vendors ensuring ethical, fair and compliant practices.
• SCM has regular communication with investigators and institutions as well as other key external and internal stakeholders.
• Adapt global templates of agreements to local use in accordance with local requirements and SOPs.
• Develop and negotiate clinical site budgets based on Fair Market Value.
• Negotiate agreement language and budget with clinical study sites.
• Act as point of contact and interface with Legal if necessary, to ensure integrity of contracts.
• For each agreement maintain the status of agreement, budgets, issues, payments, any amendments for the duration of the study, and communications with internal and external sources
• Ensure final contract documents are consistent with agreements reached at negotiations.
• Ensure all agreements are executed in a timely manner contributing to efficient site start-up timelines.
• Support internal and external audit activities.
• Ensure compliance with Company's Code of Conduct and company policies and procedures relating to people, finance, technology and security.
• Ensure that all contracts are included in the TMF
• Upon local decision, additional responsibilities may include:
  • Training and mentoring of new members of the local Study Team regarding financial/contractual issues and sharing experiences.
  • Support preparation and negotiation of a Local Master Service Agreement
  • Contribute to process improvements, knowledge transfer and best practice sharing.
    

Experience

• Bachelor Degree in related discipline, preferably in Life Science, Law, Finance or
  equivalent qualification.
• Excellent knowledge of International guidelines ICH-GCP, basic knowledge of GMP/GDP.
• Good knowledge of relevant local regulations.
• Basic understanding of the Drug Development processes.
• Good understanding of Clinical Study
• Management including monitoring, study drug handling and data management.
• Good written and verbal communication skills.
• Good collaboration and interpersonal skills.
• Good negotiation skills.
• Post-graduate training in contracts administration or work experience as a paralegal in Pharmaceutical or Healthcare industry
• Manages change with a positive approach for self, team and the business.
• Sees change as an opportunity to improve performance and add value to the business.
• Ability to look for and champion more efficient and effective methods/processes of
  delivering quality clinical trials with reduced budget and in less time.
• Good analytical and problem-solving skills.
• Demonstrates ability to prioritize and manage multiple tasks with conflicting
  deadlines.
• Ability to work in an environment of remote collaborators.
• Familiar with risk-based monitoring approach including remote monitoring.
• Ability to understand the impact of technology on projects and to use and
  develop computer skills while making appropriate use of systems/software in an enabled
  environment.
• Team oriented and flexible; ability respond quickly to stakeholders