Clinical Project Manager (m/f/d)

+49 6221 565373

UniversitätsKlinikum Heidelberg

Voßstraße 2, Geb. 4040

69115 Heidelberg, Germany

Clinical Project Manager (m/f/d)

The European Vaccine Initiative (EVI) is a non-profit organisation that is dedicated to accelerating the development of vaccines for diseases of poverty and emerging infectious diseases. We work with academic partners, pharmaceutical companies, public health institutes, The WHO, The European Commission and many other like-minded organisations across the world to discover and develop safe, effective, and affordable vaccines.

EVI has an exciting full-time opportunity for a motivated individual to join the organisation as a

Clinical Project Manager

You will join an enthusiastic non-profit organisation that includes a diverse, international team of

scientists, vaccinologists, experts in clinical trials and regulatory matters, project managers, and office

support staff.

As clinical project manager, you will work with internal colleagues and external partners on vaccine

development and the evaluation of new or improved vaccines for global health at all stages of

development, but particularly in early clinical phases. The successful candidate is expected to support

the progress of international collaborative clinical trial projects and to ensure that the clinical trials

are conducted, recorded, and reported in accordance with protocols, Standard Operating Procedures

(SOPs), Good Clinical Practice (GCP), and applicable regulatory requirement(s).

Responsibilities:

- To lead the coordination and execution of clinical trial projects

- To ensure absolute adherence to Good Clinical Practice (GCP) in accordance with ICH-GCP standards, Declaration of Helsinki, regulatory requirements, and study procedures

- To develop/update SOPs in accordance with ICH-GCP standards, Declaration of Helsinki and regulatory requirements

- To develop, review, and edit clinical trial-related documentation, including but not limited to: protocols, CRFs, Informed Consent Forms, study-specific SOPs, monitoring plans/ reports and clinical study reports

- To complete and compile all necessary research, documentation, and information in order to gain appropriate regulatory and ethical committee approval, where required

- To assist in scientific advice requests to regulatory agencies

- To interact with and manage vendors and stakeholders, as required

- To assist in project management and reporting activities

- To facilitate effective implementation of project activities, in particular the delivery of projects within agreed upon timelines and budgets

Todays catalyst for tomorrows vaccines

+49 6221 565373

UniversitätsKlinikum Heidelberg

Voßstraße 2, Geb. 4040

69115 Heidelberg, Germany

- To report and present to core teams and upper management

- To highlight and present any difficult issues that need the attention of upper management

- To maintain good working relations with key stakeholders

Qualifications/Essential Skills/Competencies:

- MD, PhD, or Masters in a relevant scientific discipline

- Minimum 3 years experience in investigational clinical research in a pharma company, product development partnership, academic clinic, CRO, or regulatory agency

- Monitoring expertise in ICH-GCP-compliant clinical trials

- Proven track record of training and adherence to ICH-GCP

- Knowledge of the EU regulatory requirements for investigational clinical trials

- Ability to contribute to the development of clinical trial-related documents and materials

- Clear understanding of the development process for new medicinal products