Local Trial Manager (m/w/d), based in Germany

IQVIA Argentina; Frankfurt; Remote; EUR 60.000 - 100.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Local Trial Manager to oversee clinical research projects across Germany. This exciting opportunity allows you to work closely with a single client, managing the intricacies of clinical trials in various therapeutic areas, particularly oncology. You will lead a local trial team, ensuring compliance with regulatory standards and contributing to process improvements. With a focus on career development and a supportive work environment, this role is perfect for those looking to make a significant impact in clinical research while enjoying the flexibility of a home-based position.

Leistungen

Competitive Benefits Package

Career Development Opportunities

Flexible Working Environment

International Scope

Supportive Work Culture

Qualifikationen

• 5+ years of clinical research experience in the pharmaceutical industry.
• Strong knowledge of GCP and ICH guidelines.
• Fluent in German (C1) and good command of English.

Aufgaben

• Act as primary contact for assigned studies, ensuring quality data delivery.
• Manage local project planning to meet recruitment targets and budgets.
• Oversee operational aspects from start-up through closeout activities.

Kenntnisse

Clinical Trial Management

Regulatory Compliance (GCP, ICH)

Oncology Expertise

Decision-Making Skills

Financial Management

IT Skills

Team Management

Ausbildung

Master's Degree in Life Science

Tools

CTMS

eTMF/LAF

SharePoint

Jobbeschreibung

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department issupporting our client’s project team in the execution of clinical trials.Joining the team provides the opportunity to work with one single client and to manage clinical research projects in different therapeutic areas.

We currently offer the exciting opportunity to join the team as Local Trial Manager (m/w/d) in full-time, supporting research projects on a local level within Germany and to work home-based throughout Germany.

Your responsibilities will include:

• Act as the primary contact at the country level for assigned studies, the LTM coordinates and leads the local trial team to ensure the delivery of quality data and trial documents/records that comply with the assigned protocol, Good Clinical Practice (GCP) codes, Standard Operating Procedures (SOPs), and regulatory requirements.
• Contribute to process improvement, training, and mentoring of Clinical Trial Assistants and CRAs.
• Oversee the operational aspects of assigned protocols from start-up through database lock and closeout activities, as outlined in procedural documents.

• Collaborate with the CPL, GTM, local management/Country Head, and Protocol Owner to finalize the site list.
• Provide input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan, and Investigational Product documents at a country level or initiates the development of these plans for single-country trials.
• Lead and coordinate local trial team activities in compliance with SOPs, Work Instructions (WI), and applicable regulations.
• Manage local project planning activities to meet recruitment targets and deliver high-quality data on time and within the study budget. This includes developing local trial-specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
• Ensure that all Serious Adverse Events (SAEs) and Product Quality Complaints (PQCs) are reported within the required timelines and documented appropriately.
• Maintain and update trial management systems (e.g., CTMS, eTMF/LAF, Trial Master Source, and SharePoint). Utilizes study tools and management reports to analyze trial progress.
• Monitor country progress, initiates corrective and preventive actions when the trial deviates from plans, and communicates study progress and issues to study management teams.
• Additionally, the LTM may have some site management responsibilities.

Qualifications:

• Master’s or higher-level degree in life science.
• Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO plus 1-3 years of local clinical trial management experience in Germany.
• Therapeutic area expertise in the field of Oncology is a must.
• Strong working knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Fluent languages skills in German on at least C1 level and good command of English.
• Strong IT skills in appropriate software and company systems.
• Excellent decision-making and string financial management skills.
• Flexibility and ability to manage study teams in a virtual environment.
• Willingness to occasional business travel for business meetings and sites visits.

We invite you to join IQVIA.

Why join us?

Ongoing development is vital to us enabling you to have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set.

Our benefits package is competitive, our scope is international, and we genuinely care about our people and their success.

Whatever your career goals, we are here to ensure you get there!

Please apply with your English CV, motivation letter and your certificates and reference letters.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com