Clinical Project Manager - Dermatology

Advanced Resource Managers; Leipzig; Remote; EUR 85.000 - 100.000; Vollzeit

Zusammenfassung

A global CRO specialized in dermatology is seeking a Clinical Project Manager responsible for leading multi-center clinical trials. The ideal candidate will have at least 6 years of experience, including managing dermatology trials with substantial budgets. The role entails overseeing project deliverables, ensuring audit readiness, and leading a project team. This position offers the potential for a remote work arrangement.

Qualifikationen

• At least 6 years of industry experience, including 3 years leading multi-center clinical trials.
• Experience managing dermatology trials at Project Management level.
• Proven ability to lead clinical trials with substantial budgets.

Aufgaben

• Oversee project deliverables, including study plans and clinical study reports.
• Ensure assigned studies are audit-ready at all times.
• Control the project budget and timelines effectively.
• Lead the core project team and ensure adequate training.

Kenntnisse

Project management

Risk management

Communication

Team leadership

Budget management

Jobbeschreibung

Overview

Clinical Project Manager - Dermatology (MUST HAVE EXPERIENCE WITHIN DERMATOLOGY AT PROJECT MANAGEMENT LEVEL)

Location: Germany (Remote)

Salary: Up to €100,000 plus bonus

My client is a full-service global CRO focusing on the therapeutic area of Dermatology. The founder of the business is a Medical Dermatologist and is therefore very passionate about these therapy areas.

With expansion in North America, Europe, Asia Pacific and Latin America, vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute their studies.

Responsibilities

• Project planning – Oversee and actively participate in the preparation of project deliverables, including study plans, protocols, informed consent forms, electronic case report forms (eCRFs), tables / listings / figures (TLFs), and clinical study reports.
• Participate in the planning and conduct of the Investigator’s Meeting.
• Ensure that each site has the necessary materials to perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).

• 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, and 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, and Scientific Affairs.

Experience

• At least 6 years of industry experience, including a minimum of 3 years leading multi-center clinical trials (phase II-III)
• Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD
• Experience managing dermatology trials at Project Management level

Please contact Chris Boateng at [e-mail] or apply via LinkedIn