Pricing and Contract Strategy Manager

Description:

LOCATION: Local to Wilmington: HYBRID (3 days onsite/2 days remote)
*Possibility for FTE Conversion*

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.
SCM might have different internal titles based on the experience level . The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head or Executive Director, Regional Head).

Typical Accountabilities
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 client'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.


Education, Qualifications, Skills and Experience

Essential Desirable
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
process.
Good understanding of Clinical Study
Management including monitoring, study
drug handling and data management.
Excellent attention to details.
Good written and verbal communication
skills.
Good collaboration and interpersonal skills.
Good negotiation skills.
Ability to work in an environment of remote
collaborators.
Post-graduate training in contracts
administration or work experience as a
paralegal in pharmaceutical or health care
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.
Familiar with risk-based monitoring approach
including remote monitoring.
Good cultural awareness.
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