Clinical Operations Manager
vor 3 Wochen
Job Summary
We are seeking an experienced Clinical Operations Manager to join our team at Pharmiweb. The successful candidate will be responsible for driving the development of operational trial-related documents and procedures, as well as setting up and supervising External Service Providers (ESPs).
Key Responsibilities
- Manage operational trial-related activities in close collaboration with other functions, including site initiations, site closures, and import/export licenses for materials and IMP.
- Select and manage ESPs, including performance assessments and finance management.
- Develop and implement ESP specifications, testing, and implementation in collaboration with other functions.
- Supervise deliverables towards the Contract Research Organization (CRO) and ESPs selected for the trial.
- Lead the development of trial-related operational documents and ensure quality control of deliverables.
- Consolidate information on operational clinical trial level activities for reporting to the Clinical Trial team (CTT).
- Resolve operational issues in a proactive and timely fashion.
Requirements
- Bachelor of Science degree or equivalent University degree in life sciences or healthcare.
- 4 years of experience in managing operational aspects of Phase II and Phase III trials and executing a wide range of clinical trial activities from study start-up to clinical study report.
- Experience in working in global cross-functional (matrix) and multicultural teams.
- Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines.
- Strong computer skills, including proficiency in Microsoft (MS)-based applications.
- Excellent verbal and written communication skills in English.
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