Clinical Trial Operations Manager
vor 1 Woche
We are seeking a highly skilled Clinical Trial Operations Manager to join our team in Germany. As a key member of our Clinical Project Management team, you will be responsible for the operational management of clinical trials, ensuring timely and cost-effective delivery of high-quality results.
Key Responsibilities:
- Manage the execution of clinical studies, including orchestration of local trial teams and integration with other functions as necessary.
- Ensure compliance with ICH-GCP and all other relevant regulatory regulations, as well as client SOPs and values.
- Collaborate with other functional groups to support milestone achievement and manage study issues and obstacles.
- Monitor progress against contract and prepare/present project information to stakeholders.
- Achieve project quality by identifying quality risks and issues, responding to issues raised by the project team, and planning/implementing corrective and preventative action plans.
- Build and lead cross-functional project teams, responsible for managing cross-collaboration and overall project delivery.
- Ensure the financial success of the project, optimizing speed, quality, and cost of delivery, and forecasting opportunities to accelerate activities.
- Participate in bid defense presentations in partnership with Business Development.
- May be assigned as the primary contact for vendors, leading project vendor management and vendor management-related activities.
Requirements:
- Bachelor's or higher-level degree in life science.
- 5 years of prior relevant experience, including project management experience, or equivalent combination of education, training, and experience.
- Expertise in covering the project management of clinical trials in different study phases and preferably in the therapeutic area of oncology.
- Knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Fluent German language skills 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 ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Flexibility to occasional business travel for client meetings.
About IQVIA:
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, improving patient outcomes and population health worldwide.
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