Introduction to the role:

This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English and Spanish is required.

Are you ready to turn rigorous contracting and sharp negotiation into faster study start-up and better outcomes for people living with cancer? The Senior Study Contract Manager 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.

The Senior Study Contract Manager has regular communication with investigators and institutions as well as other key external and internal stakeholders.

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 audits 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 the TMF

Additional responsibilities:

- 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.

Essential Skills:

- 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 travel nationally/internationally as required.

Desirable 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 e-enabled environment.
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
- Good medical knowledge and ability to learn relevant AZ Therapeutic Areas.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are driven by a vision to eliminate cancer as a cause of death. Our team is dedicated to pioneering new frontiers in Oncology, fusing cutting-edge science with the latest technology to achieve breakthroughs. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we are empowered to lead at every level. We make bold decisions driven by patient outcomes, collaborating seamlessly with academia and industry to expedite research in some of the hardest-to-treat cancers. Join us in making a meaningful impact on millions of lives.

Ready to take the next step in your career?

Date Posted