Local Study Manager

THIS IS A REMOTE POSITION

Summary of the group

Lead and coordinate activities that ensure quality, consistency, and integration of study data and progress operational deliverables to time cost and quality objectives from Study start-up through study close-out activities and Clinical Study Report (CSR). Work with US local study team, with internal and external partners, on local studies across different phases of drug development and different therapy areas.

Must have experience in cell therapy

Main Duties & Responsibilities

• Coordinate operational aspects of AZ 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 the facilitation of communications with GST, Strategic Partners, Academic clinics and investigational study sites, as appropriate, and external service providers (Third Party Vendors) to identify and 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 (e.g., VCV)

• 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 (e.g. Investigator/Monitors meeting)

• Monitor study conduct and progress, proactively identifying and resolving with the LSAD issues which may impact delivery of the study or to the necessary quality, timeline or budget objectives

Education & Experience Requirements:

Minimum Requirements

Bachelor of Science degree in related discipline, preferably in medical, biological, or health related sciences, or equivalent work experience in directly related fields

3 years ofexperience working on clinical studies, across different phases of drug development

Relevant industry or health care 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, e.g., with internal and external partners, on global studies, across different phases of drug development or different therapy areas

• Good understanding of clinical data flow

The annual base salary for this position ranges from $105,735.20 - 158,602.80 USD

However, 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) or to receive a retirement contribution (hourly 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 salary (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.