Clinical Project Manager (m/f/d) – Germany, IQVIA
- IQVIA is seeking a Clinical Project Manager to join its clinical Functional Service Partnerships (FSP) department.
- The Clinical Project manager will be responsible for overseeing all aspects of clinical trial execution within Germany.Key responsibilities include:
- Candidates for the Clinical Project Manager position should possess the following qualifications:
IQVIA Seeks Clinical Project Manager for Home-Based Role in Germany
Table of Contents
- IQVIA Seeks Clinical Project Manager for Home-Based Role in Germany
- IQVIA Clinical Project Manager Role in Germany: Your Questions Answered
- What is the role of a Clinical Project Manager at IQVIA?
- What are the key responsibilities of this clinical Project Manager position?
- What qualifications are needed to be a successful applicant?
- What is the significance of having experience in ‘startup environments’?
- What is the role of the Local Study Team?
- Why are fluency in German and cardiovascular knowledge significant?
- How does IQVIA describe itself?
- How can I apply for this Clinical Project Manager position?
IQVIA is seeking a Clinical Project Manager to join its clinical Functional Service Partnerships (FSP) department. This full-time position, based in Germany, offers the opportunity to manage clinical research projects across various therapeutic areas while working remotely.
Responsibilities
The Clinical Project manager will be responsible for overseeing all aspects of clinical trial execution within Germany.Key responsibilities include:
- identifying, qualifying, setting up, initiating, monitoring, and closing clinical trial sites, ensuring proper documentation and archiving.
- Maintaining overall responsibility for study commitments within the country, ensuring timely and high-quality data delivery.
- Leading and optimizing the performance of the Local Study Team, comprising Clinical Research Associates (CRAs) and Clinical Study Assistants (CSAs), in compliance with Standard Operating Procedures (SOPs), protocols, ICH-GCP guidelines, and local regulations.
- Conducting clinical and operational feasibility assessments of potential studies.
- Coordinating the site selection process, including identifying potential investigators, performing initial Site Quality Risk Assessments, and conducting Site Qualification Visits.
- Ensuring timely submission of applications and documents to Ethics Committees (EC) and Institutional Review Boards (IRB) at study start-up and throughout the study duration. collaborating with Regulatory Affairs to ensure timely submissions to Regulatory Authorities, adhering to local regulations.
- Preparing country financial Study Management Agreements and maintaining accurate study budgets in the clinical financial system.
- Preparing local Master CSA agreements, including site budgets and amendments.
- Perhaps contributing to on-site monitoring activities.
Qualifications
Candidates for the Clinical Project Manager position should possess the following qualifications:
- A master’s degree or higher in life sciences.
- A minimum of seven years of clinical research experience in the pharmaceutical industry or a Contract Research Organization (CRO), including at least two years of local clinical trial management experience.
- Extensive experience in feasibility assessments.
- Proven track record in managing clinical projects within startup environments.
- Specialized knowledge in cardiovascular indications.
- Understanding of rapid recruitment processes.
- Ability to influence and promote studies at various sites.
- Strong working knowledge of Good clinical practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Fluency in German (C1 level or higher) and proficiency in English.
- Strong IT skills in relevant software and company systems.
- Excellent decision-making and financial management skills.
- Versatility and ability to manage study teams in a virtual environment.
- Willingness to travel for meetings and site activities (approximately 10% of working time).
To Apply
Interested candidates are encouraged to apply with an English CV, a motivation letter, and relevant certificates and reference letters.
About IQVIA
IQVIA describes itself as a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. The company aims to accelerate the growth and commercialization of innovative medical treatments to improve patient outcomes and population health.
IQVIA Clinical Project Manager Role in Germany: Your Questions Answered
Are you a skilled clinical research professional looking for a home-based role in Germany? IQVIA is currently seeking a Clinical Project Manager. Let’s dive into the details and answer some common questions about this exciting possibility.
What is the role of a Clinical Project Manager at IQVIA?
The Clinical Project manager at IQVIA (specifically within the Functional Service Partnerships (FSP) department) is responsible for the complete management of clinical trials within Germany. This involves overseeing all aspects of trial execution, from initial site selection to final study closure. The role is home-based, offering a flexible work environment.
What are the key responsibilities of this clinical Project Manager position?
As outlined in the job description, the Clinical Project Manager’s responsibilities are extensive and include:
- Identifying, qualifying, setting up, initiating, monitoring, and closing clinical trial sites, ensuring proper documentation and archiving.
- Maintaining overall obligation for study commitments within the country, ensuring timely and high-quality data delivery.
- Leading and optimizing the Local Study Team (CRAs and CSAs).
- Conducting clinical and operational feasibility assessments.
- Coordinating site selection.
- Ensuring timely submissions to Ethics Committees (EC) and Institutional Review Boards (IRB).
- Collaborating with Regulatory affairs.
- Preparing financial documents and managing study budgets.
What qualifications are needed to be a successful applicant?
To thrive in this role,candidates should possess the following qualifications,as highlighted in the job posting:
- A master’s degree or higher in life sciences.
- A minimum of seven years of clinical research experiance, ideally in both the pharmaceutical industry and a CRO. Two years of local clinical trial management experience is essential.
- Extensive experience in feasibility assessments.
- A proven track record in managing clinical projects within startup environments.
- Specialized knowledge in cardiovascular indications is a plus.
- An understanding of rapid recruitment processes.
- The ability to influence and promote studies across different sites.
- A strong working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Fluency in German (C1 level or higher) and proficiency in English.
- Strong IT skills, notably with relevant software and company systems.
- Excellent decision-making and financial management skills.
- Versatility and the ability to manage study teams remotely.
- Willingness to travel approximately 10% of the time.
What is the significance of having experience in ‘startup environments’?
Experience in managing clinical projects within ‘startup environments’ suggests the need for adaptability, efficiency, and the ability to navigate rapidly changing circumstances. Startups often require a more hands-on, resourceful approach to project management. this experience implies a capacity to function with less established systems, which is valuable in the fast-paced clinical research field.
What is the role of the Local Study Team?
The Local Study Team, mentioned in the responsibilities, consists primarily of Clinical Research Associates (CRAs) and Clinical Study Assistants (CSAs). The Clinical Project Manager is responsible for leading and optimizing this team’s performance, ensuring they adhere to all relevant SOPs, protocols, and regulatory guidelines. The team manages day-to-day trial activities at the study sites.
Why are fluency in German and cardiovascular knowledge significant?
Fluency in German (C1 level or higher) is essential due to the role’s focus on managing clinical trials within Germany. This skill is necessary for communicating effectively with sites, regulatory bodies, and the Local Study Team. Specialized knowledge in cardiovascular indications is a plus given that IQVIA undertakes studies in many therapeutic areas. This expertise can be valuable for understanding the nuances of trials.
How does IQVIA describe itself?
IQVIA describes itself as a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. The company aims to accelerate the growth and commercialization of innovative medical treatments to improve patient outcomes and population health.
How can I apply for this Clinical Project Manager position?
Interested candidates should apply with an English CV, a motivation letter, and relevant certificates and reference letters, as noted in the job description.