BP SMO Global Study Manager

AstraZeneca; Warszawa; On-site; PLN 260,000 - 360,000; Full time

Job summary

AstraZeneca Warsaw is seeking a Global Study Manager to support delivery of clinical studies from CSP development through CSR and archiving within BioPharmaceuticals Clinical Operations. The GSM collaborates across internal and external partners, ensures documentation quality, supports budget management, and maintains inspection readiness in line with ICH/GCP, AZ SOPs and company values.

This role requires strong leadership, strategic oversight and the ability to manage vendors and CROs to

Qualifications

• University degree in medical or biological sciences.
• At least 3 years' pharmaceutical/clinical research experience.
• In-depth knowledge of ICH/GCP guidelines.
• Strong communication and stakeholder-management skills.
• Proven project management and leadership abilities.

Responsibilities

• Oversee study delivery with AZ and external partners.
• Prepare delegated study documents and related materials.
• Coordinate with CROs and external providers for on-time delivery.
• Plan and conduct study meetings with investigators/monitors.
• Ensure supply of investigational product and materials.
• Identify risks and develop mitigation plans.
• Verify study documents in Trial Master File.
• Support budget management and invoice reconciliation.
• Adhere to ICH/GCP and AZ SOPs for inspection readiness.
• Lead process improvements on non-drug projects.

Skills

Project management

Leadership

Communication

English proficiency

Education

Bachelor's degree in medical or biological sciences

Job description

Job Description

The Global Study Manager is a member of the extended global study team supporting delivery of clinical studies within BioPharmaceuticals Clincal Operations, Study Management to time, cost and quality, from Clinical Study Protocol (CSP) development through study set-up, maintenance, close-out, development of Clinical Study Report (CSR) to study archiving.

The GSM works cross-functionally with internal and external partners to deliver delegated aspects of the clinical study in accordance with Global Study Director (GSD) or Global Study Associate Director (GSAD) in delegated aspects of clinical study execution in accordance with the Delivery Model, AZ Project Management Framework, current clinical trial regulations (e.g. ICH GCP), AstraZeneca Standard Operating Procedures (AZ SOPs), AZ policies and best practices (e.g. AZ guidelines) and in line with AZ values and behaviours.

Responsibilities:

• In partnership with AZ team, other AZ clinical experts and external service providers, the GSM provides oversight to ensure study delivery.
• Leads/contributes to the preparation of delegated study documents (e.g., Informed Consent Form, master Clinical Study Agreement etc), and external service provider related documents (specifications, study specific procedures, descriptions, presentations etc).
• Maintains and facilitates interactions with internal functions and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives.
• Contributes to the planning and conduct of internal and external meetings (e.g., Investigators’/Monitors’ meeting).
• Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate.
• Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues.
• Ensures that all study documents in scope of GSM’s responsibilities are complete and verified for quality in Trial Master File.
• Supports GSD and/or GSAD with budget management, such as external service provider invoice reconciliation.
• Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times.
• Supports GSD and/or GSAD with overall project management as per agreed delegation.
• For outsourced studies, supports GSD and/or GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant AZ SOPs and guidelines (e.g., description of services and transfer of obligations)
• Take on assignments on non-drug project work in process improvements and/or leading improvement projects as discussed and agreed upon with their manager

Requirements:

Essential

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
• Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years.
• Knowledge of clinical development / drug development process in various phases of development and therapy areas
• Excellent knowledge of international guidelines ICH/GCP
• Excellent communication and relationship building skills, including external service provider management skills
• Good project management skills
• Demonstrated ability to collaborate as well as work independently
• Demonstrated leadership skills
• Computer proficiency, advanced computer skills in day-to-day tasks
• Excellent verbal and written communication in English

Desirable

• Advanced degree
• Experience in all phases of a clinical study lifecycle
• Basic knowledge of GXP outside of GCP (i.e GMP/GLP)

Date Posted

25-sie-2026

Closing Date

31-sie-2026

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 is. 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.