Global Study Manager – Single Sponsor, Dedicated

IQVIA

Global Study Manager working with global partners to deliver clinical studies and ensure inspection readiness. Leading document preparation, risk management, and project oversight within clinical operations.

Posted 7/14/2026full-timeWarsaw • 🇵🇱 PolandMid-LevelSenior💰 PLN 171,500 - PLN 404,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical study management, including document preparation, risk mitigation, and compliance with ICH/GCP guidelines. Proficient in project management and external service provider collaboration to ensure timely and quality study delivery.

Highest-signal resume keywords

Clinical Development KnowledgeICH/GCP ComplianceProject Management SkillsExternal Service Provider ManagementCommunication and Relationship Building

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Study Document PreparationRisk Identification and MitigationBudget ManagementTrial Master File VerificationInvestigational Product Supply Management

Soft Skills

Leadership SkillsCollaborationIndependent WorkExcellent Verbal CommunicationExcellent Written Communication

Tools & Technologies

Clinical Supply Chain ManagementProject Management Software

Industry Keywords

Pharmaceutical IndustryClinical ResearchDrug Development ProcessQuality & ComplianceStudy Delivery Standards

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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 Internal BioPharmaceuticals Clinical Operations Job Description relevant client's 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

What you’ll need

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

Benefits

Comp & perks

Health and welfare benefits
Bonuses
Professional development opportunities