Senior Clinical Associate

Takeda

Województwo mazowieckie

On-site

PLN 128,000 - 176,000

Full time

11 hours ago

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Job summary

Takeda in Warsaw, Poland, seeks a Senior Clinical Study Associate to support operational execution of global clinical studies within a designated therapeutic area. You will work with Clinical Study Managers (CSMs), COPLs, and SETs to deliver studies compliant with development plans, regulatory requirements, and Takeda standards.

This role requires a proactive, detail-oriented operations professional who thrives in a collaborative, global environment and drives excellence across complex studies.

Qualifications

Bachelor's degree in Life Sciences or related field.
2–4 years in pharma, CRO, or clinical research environment.
Experience with Phase II/III global clinical studies.
Oncology exposure is advantageous.

Responsibilities

Proactively manage day-to-day clinical study activities in line with ICH-GCP and Takeda SOPs.
Support medium to high complexity global studies and multiple studies/programs.
Collaborate with CSMs and SETs to meet study timelines and objectives.
Identify risks and contribute to issue resolution.
Ensure study activities align with plans and operating model.

Skills

English proficiency

Organizational skills

Problem solving

Stakeholder management

Communication

Independent work

Team collaboration

Quality and compliance

Education

Bachelor's degree in Life Sciences

Tools

CTMS

eTMF

Clinical trial platforms

Job description

Job Description

Senior Clinical Study Associate

At Takeda, we are committed to transforming patient care through the development of innovative medicines. We are seeking a Senior Clinical Study Associate (Sr CSA): to join our Global Clinical Development Operations (GCDO): team in Warsaw, Poland:

As a key member of the Study Management team, you will support the operational execution of global clinical studies within a designated therapeutic area. Working closely with Clinical Study Managers (CSMs), Clinical Operations Program Leads (COPLs), and Study Execution Teams (SETs), you will play an essential role in delivering clinical studies in accordance with development plans, regulatory requirements, and Takeda standards.

This position is ideally suited to a proactive, detail-oriented clinical operations professional who thrives in a collaborative global environment and enjoys driving operational excellence across complex clinical studies.

Key Responsibilities

Study Execution & Operational Delivery

Proactively manage day-to-day clinical study activities, ensuring compliance with study protocols, ICH-GCP guidelines, and Takeda SOPs.
Support medium to high complexity global clinical studies, with responsibility for one or more studies and/or programs.
Collaborate closely with Clinical Study Managers and Study Execution Team members to deliver study objectives and timelines.
Anticipate operational needs, identify risks, and contribute to effective issue resolution.
Ensure study activities are executed in alignment with study-specific plans and the established operating model.

Study Start-Up & Site Activation

Support study start-up activities and site initiation processes.
Track site activation progress and elevate issues when required.
Review Site Initiation Visit (SIV) reports and Essential Document Packages (EDP) in collaboration with Study Start-Up teams where applicable.
Assist with the review and maintenance of study plans, documents, and operational deliverables.

Clinical Systems & Documentation

Maintain and update clinical trial systems and study documentation on behalf of the Clinical Study Manager.
Ensure accuracy and completeness across systems such as Clinical Trial Management Systems (CTMS) Electronic Trial Master File (eTMF) COMPASS and other study platforms
Support inspection readiness activities by overseeing delegated tasks and ensuring documentation quality.

Vendor & Stakeholder Management

Contribute to sponsor oversight and vendor management activities.
Review site monitoring visit reports.
Track vendor deliverables and study budgets under the guidance of the Clinical Study Manager.
Collaborate cross-functionally with internal and external stakeholders to support study objectives.

Study Close-Out & Inspection Readiness

Support study close-out activities, including Documentation finalization Financial reconciliation Submission-support activities such as data review
Lead delegated close-out activities independently where appropriate.
Support audit preparation, participation, and inspection readiness initiatives.
Contribute to regulatory inspection preparations and attendance when required.

Continuous Improvement & Team Development

Identify operational risks, process gaps, and opportunities for improvement.
Escalate issues appropriately to ensure continuity of study operations.
Act as a subject matter expert within the CSA community.
Support onboarding, training, mentoring, and knowledge-sharing initiatives.
Contribute to department-wide and cross-functional projects as required.

What You’ll Bring

Education

Bachelor's degree in Life Sciences, Health Sciences, Technology, or a related discipline.
Equivalent combinations of education, training, and experience will also be considered.

Experience

Minimum 2-4 years of experience: within the pharmaceutical industry, clinical research organization (CRO), or a related clinical research environment.
Experience supporting Phase II and/or Phase III clinical studies:.
Experience working on global clinical trials:.
Exposure to multiple therapeutic areas; oncology experience is advantageous.

Technical Knowledge

Strong understanding of ICH-GCP Global clinical research regulations Clinical trial compliance requirements
Experience working with CTMS eTMF platforms Other clinical trial technology systems
Understanding of vendor oversight and inspection readiness processes.

Skills & Competencies