Site Contract Associate Director (SCAD) at AstraZeneca

Posted in Other 6 days ago.

Location: Boston, Massachusetts

Job Description:

This is what you will do:

The Site Contract Associate Director (SCAD) is responsible at country level for providing leadership, direction, and guidance through process improvement, interactive communication and stakeholder management.

The Site Contract Associate Director (SCAD) will support country oversight of the Master clinical study agreement, single clinical study agreement and applicable amendments 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 for assigned studies. The SCAD is a member of local study team(s).

The Site Contract Associate Director (SCAD) works in close collaboration with study sites , PMCO, SSU, CRAs and other supporting functions as well as the Clinical Trial Team (CTT) to ensure clinical study agreement execution prior to site activation deliverables within the timelines and in an efficient manner.

SCAD will serve as central point for escalation of all legal, contract language and budget escalations.

You will be responsible to:

  • Drive a consistent and effective operating model to standardize the Master and Clinical Study Agreements (CSAs) and Budget

  • Demonstrate accurate knowledge of regulations and policies in order to be able to maintain and develop the effectiveness of Clinical Study Agreements

  • Improve to the development and execution process of contracts and budgets, in collaboration with local and global teams

  • Demonstrate a strong understanding of how the contracting process and budget contributes to PMCO (schedule/cost forecasting and risk management)

  • Coordinate budget escalation approvals with relevant stakeholders.

  • Act as point of contact and interface with Legal if necessary to ensure contract integrity

  • Lead preparation and delivery of study documents related to CSA and payments

  • Build a partnership with site contract and budget team, and lead remote site discussions to resolve and finalize contracts in an expedited manner

  • Attend and engage in scheduled study team meetings

  • Share information (metrics) on site progress towards the activation within local study teams and Senior Management as required

Upon local decision, additional responsibilities may include*:

  • Lead and implement global agreed strategies including process and technology related to Study Delivery

  • Lead initiatives to ensure continuous improvement

  • Lead operational teams to deliver standardized and improved processes and tools.

  • Ensure all Country Operations (COM) systems are continuously updated

  • Implement and serve as SME for financial systems , if applicable

  • Collaborate across COM to manage and coordinate SM&M resources thus ensuring optimal resource utilization

  • Work with COM directors (HCOs, RHCOs) to support resource forecasting, analysis and solution building to resource local study teams

You will need to have:

  • Bachelor degree required, preferably in life science, law, finance or equivalent qualification or experience.

  • Four or more years of experience in the pharmaceutical industry working with delivery of clinical studies

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

  • Good knowledge of relevant local regulations

  • Good collaboration, negotiation, and interpersonal skills.

  • Excellent attention to details.

    • Excellent written and verbal communication skills.

  • Comprehensive knowledge of the drug development process.

  • Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines

  • Good understanding of Clinical Trial processes including start up, monitoring, study drug handling and data management.

  • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.

We would prefer for you to have:

  • Veeva Clinical Vault Experience

  • Experience at CRO or Sponsor in a similar position

  • 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.

  • Good analytical, problem-solving and conflict resolution skills.

  • 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 cultural awareness

Expectation of working in the office 3 days a week: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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.

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 authorization and employment eligibility verification requirements.
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