Project Manager - EP

Parexel; Berlin; Vor Ort; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

Parexel in Berlin seeks a Project Manager for our Early Phase Unit to lead Phase I and II studies. This full-time, office-based role combines clinical research expertise with strong program management to deliver on time, on budget, and to high quality standards.

You will coordinate Parexel and Sponsor teams, manage sponsor communications, and ensure compliance with ICH-GCP and SOPs while guiding cross-functional vendors.

Qualifikationen

• Proven project management experience in clinical research.
• Experience leading functional teams in clinical/data management/logistics or coordinating clinical trials.
• English and German presentation and communication skills.

Aufgaben

• Initiate, plan, manage and close out Phase I and II projects with EPCU Berlin and vendors.
• Owns sponsor relationships and communications.
• Provides a central point of study contact for functional teams and vendors.
• Continuous reporting and update of project progress with sponsor and vendors.
• Lead team meetings to ensure project objectives are met.
• Budget control for Phase I/II studies including forecasting and invoicing.
• Ensure compliance with SOPs, contract terms and system requirements.
• Set up project-specific training in Parexel systems and oversee training.

Kenntnisse

Project management

Team leadership

English German

MS Office

Clinical research

Ausbildung

Bachelor's degree in science

Scientific/Medical/Pharmacology background desirable

Tools

MS Office Suite

Jobbeschreibung

An exciting opportunity for a Project Manager for our Early Phase Unit in Berlin. This role is a full-time and office-based position that will manage Phase I and II studies.

The Project Manager (PM) leads the Parexel and Sponsor teams by combining a depth of clinical research experience and project management skills with insight into sponsor pressures and an ability to develop the right solution for each sponsor.

Accountable for the successful delivery of projects/programs (on time, on budget, to the highest quality) compliant with ICH, GCP, and other applicable documents and regulations. Ensures the project teams achieve operational excellence and successful execution of the clinical operations and logistical strategy.

Key Accountabilities

• Initiate, plan, manage and close out of Phase I and II projects with all departments of the EPCU Berlin including external vendors and external units as required
• Owns the sponsor relationship and is responsible for sponsor communications.
• Provides a central point of study contact on behalf of the functional teams and vendors.
• Continuous reporting and update of project progress including communication internally and with sponsor and external vendors
• Lead team meetings on a regular basis with project team to ensure project objectives are met.
• Budget control for Phase I and II studies including: Service inquiries with external vendors, Budget and contract negotiation with sponsors and external vendors, Forecasting, tracking and invoicing
• Understands and ensures compliance with SOP's, contract terms and system requirements.
• Responsible for the setup of project specific training in Parexel system and oversight of training.

Skills & Knowledge

• Proven Project Management experience in the field of clinical research
• Experience as a functional team leader in clinical/data management/logistics function or proven experience in coordinating clinical trials
• Presentation, speaking skills in English and German
• Organizational talent and Ability to work under pressure and multitask
• In depth knowledge of guidelines, ICH-GCP and AMG.
• Solid computer and internet skills including knowledge of MS Office (e.g. Excel, Word, PowerPoint and Project).

Education

• Bachelor's degree in a science related filed or a wealth of related work experience as a clinical research project manager.
• Scientific / Medical / Pharmacology background desirable.