Project Manager II (Poland)

Indero; Polska; Remote; PLN 434,000 - 749,000; Full time

Benefits offered by this job

Permanent full-time position

Vacation and health allowance

Teleworking allowance

Job summary

Indero seeks an experienced Project Manager II to lead multisite clinical trials from initiation through closure. You will coordinate cross-functional teams, manage budgets, and ensure adherence to GCP, ICH, and regulatory standards across global Phase I–III studies.

You will act as a primary liaison with sponsors, drive trial progress, and contribute to feasibility and study design while maintaining timelines and quality. Remote-friendly role with international scope.

Qualifications

• Bachelor-level education in clinical research or related field.
• Strong knowledge of GCP/ICH and regulatory requirements.
• Experience leading Phase I–III trials and multi-center studies.

Responsibilities

• Manage initiation, planning, execution, monitoring and closure of trials.
• Coordinate resources, timelines, budgets and vendor activities.
• Lead client calls and provide timely trial progress updates.
• Prepare study plans, protocols, ICFs, eCRFs and TLFs; review deliverables.
• Oversee site activation, TMF setup and regulatory submissions.
• Ensure audit readiness and monitor data quality and timelines.

Skills

GCP

ICH standards

Regulatory knowledge

MS Office

English communications

Budget management

Project leadership

Clinical trial management

Cross-functional collaboration

Education

B.Sc. in a related field of study to clinical research

Job description

The project manager II has the overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials. The project manager II oversees and coordinates study resources to ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. Project Manager II acts as the main line of communication to relevant stakeholders and provides input to feasibility, study design, budget development and ensures progress reporting (resources, budget and timeline) This role will be perfect for you if: You want to work for a mid-sized CRO that works on significant multisite trials, including Global Phase III projects You are looking to position yourself in an environment where you can grow your career alongside the company

IMPACT AND RESPONSIBILITIES

• Client interactions
• Serve as primary contact for the Sponsor
• Provide efficient and timely updates on trial progress
• Lead client calls effectively
• Project planning
• Oversee and actively participates in the preparation of project deliverables such as; study plans, protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report.
• Participate in the planning and conduct of the Investigator's Meeting.
• Ensure that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).
• Lead study start-up activities including trial kick-off, TMF setup, site selection and activation, vendor set-up timelines, and site contracting and budgeting.
• Collaborate with Regulatory Affairs to ensure timely submissions and completeness of essential documents prior to site initiation and throughout the study.
• Partner with Data Management to ensure CRF alignment with protocol and sponsor requirements, and that data review, query resolution, and database lock timelines are met.
• Quality and risk management
• Ensure assigned studies are "audit ready" at all times.
• Monitor the quality of study deliverables, (including vendor and SubCRO deliverables) and address issues as they arise.
• Manage risk and control measures to assure project quality.
• Analyze discrepancies between planned and actual results.
• Review and approve responses to quality assurance audits.
• Project budget and timelines
• Control the project budget, with particular attention to internal hours allocated to all activities.
• Identify out of scope activities for change orders.
• Proactively manage operational aspects of the clinical trial including trial timelines, budget, resources and vendors.
• Coordinate tasks and deliverables from all functional departments involved in the project.
• Communicate effectively with study team members, functional departments, and senior management.
• Manage and report on recruitment status and highlight initiatives needed to meet recruitment timelines.
• Project team leadership
• Lead the core project team which may include: Associate Project Managers, Project Coordinators, Project Assistants.
• Ensure all team members have adequate training on the project.
• Work closely with vendors and the following internal teams to ensure all tasks and deliverables are completed on time, according to plans and according to applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs.
• Define and maintain the project-specific training matrix and ensure training records are kept up to date throughout the study.
• Requirements
• Education B.Sc. in a related field of study to clinical research Experience At least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project management Experience managing dermatology and/or rheumatology trials Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD. Experience managing dermatology trials an asset Knowledge and skills Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations Excellent knowledge of Microsoft Office suite Excellent oral and written skills in English, French is an asset Excellent communication skills Ability to work in a team environment and establish good relationships with colleagues and sponsors Good problem-solving abilities Good organizational skills Strong ability to carry out different projects and work under pressure while meeting timelines

Requirements

Education B.Sc. in a related field of study to clinical research Experience At least 5 years industry experience and a minimum of 3 years in Phase I-III clinical trial project management Experience managing dermatology and/or rheumatology trials Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD. Experience managing dermatology trials an asset Knowledge and skills Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations Excellent knowledge of Microsoft Office suite Excellent oral and written skills in English, French is an asset Excellent communication skills Ability to work in a team environment and establish good relationships with colleagues and sponsors Good problem-solving abilities Good organizational skills Strong ability to carry out different projects and work under pressure while meeting timelines

Our company

The work environment At Indero , you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Permanent full-time position
• Vacation, PPK, health allowance
• Home-based position with teleworking allowance
• Ongoing lear