Site Monitoring and Management Operations - Budget Analyst
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe. As a Site Contract & Budget Analyst in Wilmington, DE, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
The Site Contract – Budget Analyst you will provide leadership during the clinical agreement and site level budget negotiation process to ensure ethical, fair and compliant practices are followed when developing, negotiating and executing clinical agreements and investigator budgets. This position necessitates providing leadership, direction, and guidance through process improvement, interactive communication and stakeholder management. This role requires a high level of interactive communication to set clear direction for the study teams and external Institutions.
Duties May Include:
- Develop and negotiate clinical site budgets based on Fair Market Value. Leverage historical data, negotiation techniques with sites to realize cost savings
- Negotiate agreement language with clinical study sites to reach a shared understanding of deliverables, a timely study start-up and financial obligations.
- Be responsible for producing clinical site budget appropriate Payment Schedules based on the Protocol and AZ policy and guidelines to provide to Clinical Delivery Team.
- Act as point of contact and interface with Legal if necessary to ensure integrity of contracts.
- Drive site start-up time by striving to execute CSA within KPI.
- Attend and engage in scheduled project team meetings.
- Ensure final contract documents are consistent with agreements reached at negotiations.
- Support internal and external audits and litigation activities.
- Negotiate appropriate terms and conditions of Informed Consent Forms and other Clinical Agreements and associated documents. Ability to process agreement requests and identify correct legal entity and template to be used.
- Approve Clinical Study Agreements with final signature, according to Delegation of Authority.
- Serve as a liaison between the legal and clinical trial teams.
- Negotiate master templates with preferred or notable Institutions.
- As a subject matter expert, exhibits contract and negotiation expertise to achieve a balance between external business exposure and policies/regulations.
- As a subject matter expert, demonstrates an understanding of how contractual terms add value to internal and external customers.
- As a subject matter expert, possesses detailed and in-depth knowledge of contract precepts, the contracting process and budget development.
- Ensure compliance with AstraZeneca’s Code of Conduct and company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment).
Additional Responsibilities May Include
- Ensure timely customization and completion of the CSA for designated studies.
- Participate in training and mentoring of new members of the local Study Delivery Team ensuring compliance with ICH/GCP and AZ Procedural documents.
- Ensure that all study documents are ready for final archiving and sign-off completion of the local part of the Trial Master File.
- Contribute to process improvements, knowledge transfer and best practice sharing.
- BA or BS in relevant discipline related to Clinical Research or Business Management
- Post-graduate training in contracts administration or work experience as a paralegal in pharmaceutical or health care industry.
- Strong interpersonal, negotiation, communication and time management skills.
- Experienced user of FMV tool, specifically MEDIDATA Grant Manager tool.
- 4+ years’ experience in pharmaceutical or health care industry.
- Strong oral, written, and organizational skills.
- Knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
- Good medical knowledge in relevant AZ Therapeutic Areas.
- Basic understanding of the drug development process.
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management
- Ability to travel nationally as required
Preferred Skills and Experience Requirements:
- 7-10 years of experience as paralegal or contractor administrator in pharmaceutical industry
- Post-graduate training in contracts administration or work experience as a paralegal in pharmaceutical or health care industry
- Possess good analytical and problem-solving skills.
- Demonstrate ability to prioritize and manage multiple tasks with conflicting deadlines.
- Proven 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.
- Maintain team oriented and flexible approach; possess ability to respond quickly to shifting demands and opportunities.
- Exhibit customer focus in collaboration with sites and external stakeholders.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.