Local Study Manager

Local Study Manager

Are you ready to lead and coordinate activities that ensure quality, consistency, and integration of study data? As a Local Study Manager, you'll drive operational deliverables to meet time, cost, and quality objectives from study start-up through study close-out activities and Clinical Study Report (CSR). Collaborate with the US local study team and engage with internal and external partners on local studies across various phases of drug development and therapy areas. Are you prepared to make a difference?

Accountabilities

• Coordinate operational aspects of AstraZeneca Sponsored studies from Study start-up through CSR/Publication.
• Lead and/or participate in activities that ensure quality, consistency, and integration of study data to agreed time, cost, and quality objectives.
• Interface with field monitoring CRAs, Local Study Associate Director (LSAD), and global study team (GST).
• Establish and maintain interactions with key stakeholders including GST, Strategic Partners, Academic clinics, investigational study sites, and external service providers to resolve operational feasibility issues, facilitate study start-up activities, and ensure Operations deliverables to time, budget, and quality objectives.
• Implement globally agreed Development Operations strategies including processes and use of technical systems related to Operations.
• Contribute to the development of Operations documents as appropriate as well as any updates/amendments to those documents.
• Ensure timely entry and/or update appropriate information into AstraZeneca tracking and communication tools.
• Ensure the supply of study materials and Investigational product by liaising with Clinical Supply Chain or external service providers as appropriate.
• Contribute to the planning and conduct of any local internal and external meetings.
• Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives.
• Contribute to steering committees, submission assembly teams, regulatory defense teams, and Advisory Boards as necessary.
• Provide input into non-drug project work including training activities, and development of procedures as needed.

Essential Skills/Experience

• Bachelor of Science degree in related discipline, preferably in medical, biological, or health-related sciences, or equivalent work experience in directly related fields
• Experience working on clinical studies across different phases of drug development
• Relevant industry or healthcare experience
• Proven organizational and analytical skills
• Understanding of the clinical study and drug development process and GCP/ICH guidelines in relation to study delivery operational activities
• Computer proficiency
• Excellent knowledge of spoken and written English
• Demonstrates ability and willingness to work and lead cross-functionally on global studies across different phases of drug development or different therapy areas
• Good understanding of clinical data flow
• Excellent verbal and written communication and presentation skills
• Demonstrates ability to work independently as well as in a team environment
• Excellent interpersonal skills and proven ability to facilitate team building and teamwork
• Willingness to travel both domestically and internationally
• Demonstrates sound knowledge of GCP, AZ Procedural documents as they pertain to Study delivery systems and processes
• Proactively identifies risks and issues and possible solutions
• Demonstrates high standards and uses tactful persuasion to obtain desired outcomes while maintaining effective organizational relationships
• Develops knowledge of therapy area through experience and review of scientific literature, demonstrating ability to learn new therapy areas
• Demonstrates ability to prepare and deliver study-related training materials
• Demonstrates ability to plan, coordinate, and facilitate internal and external meetings
• Demonstrates professionalism and mutual respect
• Displays excellent organization and time management skills, attention to detail, and ability to multi-task in a high-volume environment with shifting priorities
• Ability to work in an environment of remote collaborators

Desirable Skills/Experience

• The ability to develop advanced computer skills to increase efficiency in day-to-day tasks
• Demonstrated Project Management skills (e.g., leading delivery team)
• Excellent mentoring skills and ability to develop others
• 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 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 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.

At AstraZeneca, we are driven by a shared passion for learning, growth, and discovery. Our scientific community seamlessly blends academia with industry expertise. We celebrate successes while learning from the best. With female leaders in 45% of senior roles internally, we foster diversity. Externally, our collaborations span over 26 countries worldwide. Join us in our mission to expedite research in some of the hardest-to-treat cancers.

Ready to take the next step in your career? Apply now!

The annual base pay for this position ranges from $105,735.20 - 158,602.80. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

Date Posted

Closing Date

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.