Senior Dermatology/Rheumatology Clinical PM – Germany (Remote)

Indero (formerly Innovaderm); Deutschland; A distancia; USD 85.635 - 125.599; Jornada completa

Descripción de la vacante

Indero is seeking a Senior Project Manager with dermatology and/or rheumatology trial experience to act as the primary sponsor contact and drive project success. You will lead cross-functional teams, manage study deliverables, and ensure on-time, on-budget execution across multisite trials.

Ideal candidates bring 7+ years in the industry with AD/phase II–III leadership, strong GCP/IHC knowledge, and fluent English. This role is home-based in Germany with regular international travel.

Formación

• At least 7 years of industry experience, including 5 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; rheumatology is an asset.
• Excellent knowledge of GCP, ICH standards, FDA and local country regulations.
• Fluency in English with excellent oral and written skills.

Responsabilidades

• Serve as primary contact for the Sponsor and provide updates on trial progress.
• Oversee preparation of study deliverables and participate in Investigator’s Meetings.
• Ensure studies are audit ready and monitor quality of all deliverables.
• Proactively manage trial budgets, timelines, resources, and vendor coordination.
• Lead the core project team and collaborate with internal departments and vendors.

Conocimientos

Leadership

GCP knowledge

ICH standards

FDA regulations

Fluent English

Team collaboration

Project management

Communication

Educación

B.Sc. in a relevant discipline

Herramientas

Microsoft Office

Descripción del empleo

Projects Managers with experience in Dermatology and/or Rheumatology are crucial to the success of Clinical Trials managed by Indero. They are the main point of contact internally as well as externally, ensuring all activities and deliverables are completed on time, on budget, and as expected.

Great project managers go further than creating project plans and following up on tasks. They show leadership to help project teams focus on objectives and deliver results.

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.).
  
  

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.
  
  

Requirements:

IDEAL PROFILE

Education

• B.Sc. in a relevant discipline
  
  

Experience

• At least 7 years of industry experience, including a minimum of 5 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
• Experience managing rheumatology trials an asset
  
  

Knowledge And Skills

• Excellent knowledge of GCP and ICH standards, FDA and local country regulations
• Excellent knowledge of Microsoft Office suite
• Fluency in English with excellent oral and written skills, required
• Ability to work in a team environment and establish good relationships with colleagues and sponsors
• Good problem-solving abilities
• Strong ability to carry out different projects and work under pressure while meeting timelines
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
  
  

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.

Work location

Note that this opening is for a home-based position in Germany

Regular travel, which may include overnight trips and / or international travel is required as part of this role.

About Indero

Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Germany.