Study Contracts Manager

Study Contracts Manager

Introduction to role:

Are you ready to play a pivotal role in the world of clinical trials? As a Study Contracts Manager,you'llbe at the forefront of negotiating and budgeting, ensuring ethical and compliant practices in developing and managing contracts with investigators, institutions, and external vendors. Yourexpertisewill drivecostingsand contracts, making a significant impact on the success of clinical studies. Regular communication with key stakeholders will be your forte as you navigate the complexities of clinical trial agreements.This position serves as a flexible contracting and budgeting resource, providing coverage across studies and teams based on business needs, workload balancing, and organizational priorities.

Accountabilities:

- Adapt global templates of agreements to local usein accordance withlocal requirements and SOPs.

- Develop and negotiate clinical site budgets based on Fair Market Value.

- Negotiateagreementlanguage and budget with clinical study sites.

- Act as point of contact andinterface withLegal if necessary to ensure integrity of contracts.

- Maintain the status of agreements, budgets, issues, payments, amendments, and communications for the duration of the study.

- Ensure final contract documents are consistent with agreements reached at negotiations.

- Ensure all agreements are executedin a timely manner, contributing to efficient site start-up timelines.

- Support internal and external audit activities.

- Ensure compliance with AstraZeneca ’s Code of Conduct and company policies and procedures relating to people, finance, technology, and security.

- Ensure that all contracts are included in theTMF.

- Additionalresponsibilities may include training and mentoring new members of the local Study Teamregardingfinancial/contractual issues and sharing experiences, supporting preparation and negotiation of a Local Master Service Agreement, andcontributing to process improvements, knowledge transfer, and best practice sharing.

Essential Skills/Experience:

- Bachelor’s degreerequiredin related discipline with4+ years of experiencenegotiating industry contracts such as Clinical Study Agreements,CDAs, and amendments for site, SMO, CRO,or Sponsor.

- Experience developing clinical trial budgets from study protocols, including Fair Market Value assessments.

- Ability to support multiple studies and agreement types, adapting quickly to changing business needs and priorities

- Provide flexible contracting and budgeting support across multiple studies, including negotiation of CSAs,CDAs, amendments,and budgetscreation

- Excellent knowledge of international guidelines ICH-GCP, basic knowledge ofGMP/GDP.

- Good knowledge of relevant local regulations.

- Basic understanding of the drug development process.

- Good understanding of Clinical Study Management including monitoring, study drughandlingand data management.

- Excellent attention to detail.

- Good written and verbal communication skills.

- Good collaboration and interpersonal skills.

- Good negotiation skills.

Desirable Skills/Experience:

- Ability to work in an environment of remote collaborators.

- Demonstrated ability to rapidly learnnew studiesand support contracting and budgeting needs with minimal training or oversight.

- Post-graduate training in contracts administration or work experience as a paralegal in pharmaceuticalor health care industry.

- Manages change with a positive approach for self,teamandthe 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 withrisk-based monitoring approach including remote monit