Site Engagement Lead, Associate Director (IL, OH, MI, WI)

AstraZeneca; United States; Hybrid; USD 138.000 - 207.000; Vollzeit

Zusammenfassung

AstraZeneca plc seeks an Associate Director Clinical Research to lead a dedicated team and ensure successful delivery of interventional studies in line with ICH-GCP and AZ procedures. You will oversee site management from identification to closeout, manage staffing, and drive development plans for CRAs/CSAs to achieve study goals with quality and speed.

You will mentor staff, secure necessary resources, maintain inspection readiness, and partner with senior directors to deliver country-level

Qualifikationen

• Bachelor’s degree in related discipline, preferably life science.
• Experience in pharmaceutical industry, Clinical Operations (CRA / SrCRA / LSAD) or related fields.
• Knowledge of drug development, ICH-GCP, country regulations, and AZ Therapeutic Areas.
• Clinical Study Management including monitoring, study drug handling and data management.

Aufgaben

• Provide leadership to a dedicated team and foster a high performing team climate.
• Ensure adequate resourcing for all assigned clinical studies.
• Monitor workload and ensure fair distribution among staff.
• Oversee development and performance management of direct reports.
• Maintain eTMF completeness and inspection readiness.
• Review monitoring reports and QC visits per SOPs.
• Support country-level SMM study delivery targets.

Kenntnisse

Personal Effectiveness

Learning Agility

Financial Competency

Tech & Process

English Proficiency

Integrity & Ethics

Team Leadership

Quality Delivery

Travel Readiness

Drivers License

Communication

Risk-Based Thinking

Talent Planning

Coaching

Collaboration

Ausbildung

Bachelor’s degree in related discipline

Jobbeschreibung

Summary of Role:

The Associate Director Clinical Research (ADCR) is accountable for the successful performance and management of their assigned team, ensuring the successful delivery of clinical interventional studies under her/his supervision and in line with agreed resources and timelines. All activities must be conducted in compliance with AstraZeneca Procedural Documents, international standards such as ICH-GCP, and applicable local regulations. The ADCR leads and manages dedicated staff groups, including Clinical Research Associates (CRAs) and/or Clinical Study Administrators (CSAs). This includes the planning and utilization of staffing resources, setting clear objectives, and conducting ongoing performance management and follow-up. As assigned, the ADCR oversees the full lifecycle of study site management, including site identification, qualification, set-up, initiation, monitoring, closure, and documentation archiving, according to local agreements.

Territory: IL, OH, MI, W I

Accountabilities:

• Provide leadership to a dedicated team, fostering team spirit and cultivating a positive, high performing team climate and professional behavior.

• Ensure adequate resourcing for all assigned clinical studies, enabling the team to efficiently meet study objectives.

• Regularly monitor and balance the workload of direct reports, ensuring fair distribution and manageable assignments.

• Oversee the development and performance management of direct reports, guiding them toward continuous growth and success.

• Ensure all direct reports have individual development and training plans in line with the Individual Development Plan (IDP) process.

• Provide regular coaching and mentorship, arranging external coaching support when necessary to promote professional development.

• Prepare salary and bonus proposals for direct reports in close consultation with the (Senior)

• Director, Country Head and local HR Business Partner, ensuring decisions reflect individual performance.

• Collaborate closely with the responsible (Senior) Director, Country Head, to support the effective functioning of the SMM organization at the country level.

• Contribute expertise to high-quality feasibility assessments, supporting appropriate site and study selection.

• Support the achievement of country-level SMM study delivery targets, ensuring studies are delivered to plan with both speed and quality.

• Drive quality improvement of study processes and procedures, championing best practices and continuous enhancement.

• Maintain all required systems in an up-to-date state to support efficient and compliant study conduct.

• Ensure the electronic Trial Master File (eTMF) is kept complete, accurate, and “Inspection Ready”.

• Providing direction and support to CRAs and CSAs on major study deliverables and proactively resolves key issues.

• Ensure that all study activities at the country level are aligned with local policies, regulations, and the company code of ethics.

• Review monitoring visit reports, as applicable for direct reports, and in line with AstraZeneca Standard Operating Procedures (SOPs).

• Review and evaluate accompanied/co-monitoring, training, and Quality Control visits performed by direct reports, in accordance with local QC plans.

• Perform accompanied site visits for quality assessment, ongoing coaching/development, and/or competency assessment of the team.

• Maintain open and effective communication with Functional Service Providers (FSPs), offering direction and feedback on both insourced and outsourced work.

Education and experience:

Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders. Previous experience in the pharmaceutical industry, preferably in Clinical Operations (CRA / SrCRA / LSAD) or other related fields.

Relevant knowledge and ability to fulfil key responsibilities, including but not limited to: Drug development process and related GxP processes, international guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including project management, monitoring, study drug handling and data management.

Required Skills:

• Personal Effectiveness & Drives Accountability in Others

• Learning Agility

• Financial, Technology & Process Competency

• Active Listening, Fluency in written & spoken business-level English

• Act with Integrity & high ethical standards

• Effectively lead a team across in-person and virtual settings to deliver shared goals, demonstrates cultural awareness

• Identify and champion more efficient delivery of quality clinical trials with optimized cost and time

• Ability to travel nationally/internationally as required

• Valid driving license, if country employment requirement

• Communication & Teamwork - Influencing, Collaboration, Impactful Site conversations

• Effective, risk-based thinking – Plans & Aligns, Problem Solving, Critical Thinking, Decision Making, Effective Issue Management

• Deliver Priorities Results & Impact - Recruitment/Retention Planning & Action, Ensures Accountability, Empowerment & Delegation

• Leadership - Feedforward & Coaching, Drives Engagement & Development, Building Effective Teams, Manages Conflict.

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.

The annual base pay (or hourly rate of compensation) for this position ranges from $137,937 to $206,906.Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans_._

Why AstraZeneca:

Here you will contribute to a bold mission to transform outcomes for people by advancing earlier detection and smarter, faster trials. You will operate at the intersection of innovative science and technology, backed by significant investment and an empowered, collaborative culture that brings clinicians, scientists, and data experts together to accelerate breakthroughs. We value kindness alongside ambition, giving you the trust, tools, and cross-functional partnerships to lead with confidence and shape studies that matter—so your decisions today translate into meaningful patient impact tomorrow.

Date Posted

08-Oct-2026

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.