The IQVIA sponsor-dedicated Clinical Functional Service Partnerships (Clinical FSP) department is supporting our client’s project team in the 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 accountable for the operational management of the component of clinical trials. Furthermore, you will need to gain an oversight to assure achievement of trial recruitment commitment, timelines, budget and quality standards.
MAIN RESPONSIBILITIES
• Manage the execution of clinical studies or assigned portion of Early Phase clinical studies; including orchestration of local trial team, and integration with other functions as necessary throughout planning, conduct and closeout of trial.
• Work within a complex GCP and regulatory environment and on global clinical trials with multidisciplinary, international teams and with various internal and external stakeholders including suppliers and investigational sites.
• Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts, and necessary approvals.
• Ensure compliance with ICH-GCP and all other relevant regulatory regulations as well as accordance with client SOPs and values.
• Assure highest ethical and professional standards, patient safety, and that local component of trial is planned, conducted, and reported in line with regulatory requirements.
• Set up, manage, and review operating unit trial budget to ensure appropriate level of financial oversight and timely budget updates based on trial changes.
• Assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.
• Ensure appropriate trial-specific training of internal and external partners in line with Trial Training Plan.
• Develop and maintain relationships with investigational sites and support CRAs in site contacts.
• In collaboration with Site Monitoring Lead and CRAs, ensure:
o provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and team to GCP, local regulations, customer SOPs, and adherence to trial protocol.
o adequate trial supply distribution to sites.
o continuous and timely data entry and cleaning, and on time Data Base Lock.
o collection of required documents, with timely, complete, and compliant archiving of all relevant documents for the eTMF and CTR Appendices.
• Identify risks and contingencies and partner with project leader in problem solving and resolution efforts.
• Report to and relate with Trial Leader to provide updates, exchange critical information and share trial conduction information, within regulatory and compliance burdens.
• Participate in and actively drive organizational, quality and process improvement initiatives to commence future leading change.
REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE
• Master’s or higher-level degree preferable in life science.
• Long term 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), including excellent understanding of the special business environment of Early Phase clinical trials.
• Exceptional knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Excellent understanding of project financials and effective vendor management.
• Effective communication skills, fluent languages skills in German (at least C1 level) and good command of English.
• High ability to work on abstract complex topics and to strategic thinking, as well as solution orientation.
• High organizational and planning skills, time management and prioritization skills while working on multiple projects.
• Excellent leadership and collaboration skills, and the ability to establish and maintain effective working relationships with coworkers, managers and clients. Ability to influencing business partners in matrix structures.
• High degree of self-accountability and commitment and a strong growth mindset to drive change and contribute actively to future leading transformation.
• Very good computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Flexibility to occasional business travel for client meetings.
• Strong problem solving skills.
• Ability to make decisions, bringing clarity to disparate information to inform actions and drive results.
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