Senior Clinical Project Manager - Dermatology

Advanced Resource Managers; München; Remote; EUR 93.000 - 110.000; Vollzeit

Zusammenfassung

A global CRO specializing in Dermatology is seeking a Senior Clinical Project Manager to oversee multi-center clinical trials. The role requires at least 6 years of industry experience, with a focus on dermatology. Responsibilities include managing project deliverables, ensuring audit-readiness, and leading project teams. Remote work available with a competitive salary up to €110,000 plus bonus.

Qualifikationen

• At least 6 years of industry experience, with 3 years leading multi-center clinical trials.
• Experience managing dermatology trials at Project Management level.
• Experience leading concurrent multi-centered clinical trials with budgets over $3M.

Aufgaben

• Oversee project deliverables including study plans and reports.
• Participate in planning and conducting Investigator’s Meetings.
• Ensure sites have necessary materials for studies.
• Maintain audit-readiness of assigned studies.
• Manage risk and control measures to assure project quality.

Kenntnisse

Project Management

Dermatology expertise

Quality assurance

Risk management

Budget control

Jobbeschreibung

Overview

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

Location: Germany (Remote)

Salary: Up to €110,000 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

• 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 internal teams to ensure all tasks and deliverables are completed on time, according to plans and applicable standards: Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs.

Qualifications

• 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.