Clinical Trial Manager (m/w/d), Single Sponsor, Home-Office

The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the set-up and execution of clinical trials. Joining the team provides the opportunity to manage Early Phase clinical research projects in different therapeutic areas and to cooperate closely with one of our key clients.

We currently offer the exciting opportunity to join the team as Clinical Trial Manager (m/w/d) in full-time and work home-based throughout Germany. In this role you will be responsible for the operational management of clinical trials. Furthermore, you will need to gain an oversight to assure achievement of trial start-up and recruitment commitment, timelines, budget, and quality standards.
 

RESPONSIBILITIES

• Manage assigned portions of the planning, start-up, execution, and close-out of Early Phase clinical studies, including orchestration of trial team and external vendors.
• Work within a complex GCP and regulatory environment on local, regional, and global clinical trials of Phase 1 – 2a with multidisciplinary, international teams and with various internal and external stakeholders, including vendors, investigational sites, and regulatory bodies.
• Lead and support sponsor trial teams, external vendors and investigator sites in trial set-up process and ensure the timely preparation and provision of operational trial documents, contracts, and in the submission and approval process.
• Ensure compliance with highest ethical and professional standards, ICH-GCP and all other relevant regulations as well as accordance with sponsor SOPs and values.
• Set up, manage, and review the operating unit trial budget to ensure an appropriate level of financial oversight and timely budget updates based on trial changes.
• Assigned as the primary contact for vendors, leading project vendor management-related activities as per project requirements.
• Report to and relate with the Clinical Trial Leader to provide updates, exchange critical information, and share trial conduct information, within regulatory and compliance burdens.
• Identify risks and contingencies and partner with the Clinical Trial Leader in problem-solving and resolution efforts.
• In collaboration with the Clinical Trial Leader, local CTMs, and CRAs, ensure:
• provision of appropriate trial oversight by monitoring compliance of trial sites and team to GCP, local and global regulations, customer SOPs, and adherence to the trial protocol.
• adequate trial supply distribution and sample logistics.
• continuous and timely data entry and cleaning, and on-time Data Base Lock.
• Trial-specific training of internal and external partners in line with the Trial Training Plan.
• Develop and maintain relationships with investigator sites and support CRAs in site contacts.
• Participate in and actively drive organizational, quality, and process improvement initiatives to drive future leading change.

REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE

• Master’s or higher-level degree, preferably in life science.
• Extensive experience in clinical research, including at least 2 years of clinical trial management experience.
• Significant exposure in managing Early Phase clinical trials (Healthy Volunteer and Proof of Concept trials), with a thorough understanding of the unique business environment of Early Phase clinical trials.
• In-depth knowledge of applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and EU Clinical Trials Regulation (EU-CTR).
• Strong understanding of project financials and effective vendor management.
• Effective communication skills, with fluency in English and German (at least C1 level).
• Proven ability to work on abstract and complex topics and to engage in strategic thinking, with a strong drive to develop and implement solutions.
• High motivation to manage multiple projects simultaneously in high-performing global project teams.
• Strong self-accountability, self-organization, and prioritization skills, demonstrating a committed, collaborative, and outcome-oriented mindset.
• Excellent matrix leadership and collaboration skills, with the ability to establish and maintain effective working relationships with coworkers, managers, and vendors. Ability to network and influence business partners in matrix structures, representing the sponsor’s business interests optimally.
• Strategic thinking to align tasks with business priorities.
• A strong growth mindset to drive change and actively contribute to preparing the sponsor organization for the future.
• Proficiency in computer skills, including working knowledge of Microsoft Word, Excel, and PowerPoint.
• Flexibility for regular business travel to attend client meetings.

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