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 execution of clinical trials. Joining the team provides the opportunity to work with the preparation and documentation of clinical research projects in different therapeutic areas.

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 a clinical trial. Furthermore, you will need to gain an oversight to assures achievement of trial recruitment commitment, timelines, budget and quality standards.

RESPONSIBILITIES

• Manage the execution of clinical studies or assigned portion of 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.
• 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:

• 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.
• adequate trial supply distribution to sites.
• continuous and timely data entry and cleaning, and on time Data Base Lock.

• In collaboration with Trial Resource Specialist and with supports from CRAs as appropriate, ensures collection of required documents, with timely, complete, and compliant archiving of all relevant documents for the eTMF and CTR Appendices.
• Participate in working groups related to Trial Management, represent trial on local level, providing updates on trial within operational unit.
• Report to and relate with TAM to provide updates, exchange critical information and share trial conduction information, within regulatory and compliance burdens.
• Limited business travel to client's office for meetings.

REQUIRED KNOWLEDGE, SKILLS AND EXPERIENCE

• Bachelor’s or higher-level degree preferable in life science.
• Preferable 1-3 years of clinical trial management experience, alternatively extensive experience as Senior Clinical Research Associate plus clinical trial oversight experience.  
• 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.
• Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
• Effective communication, organizational and planning skills.
• Planning, time management and prioritization skills while working on multiple projects.
• Excellent leadership skills, and the ability to establish and maintain effective working relationships with coworkers, managers and clients.

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.

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