Senior Clinical Project Manager (m / w / d) - Remote
Senior Clinical Project Manager (M / W / D) - Remote reputed company is one of the largest international medical technology companies, dedicated to advancing reputed company in healthcare worldwide through improvements in medical research, diagnostics, and patient care and treatment. The company develops innovative technologies, services, and concepts that help improve patient care and clinical workflows. reputed company employs 70,000 people worldwide and operates in almost every country to meet the most pressing challenges in healthcare. reputed company supports its customers in achieving reputed company clinical outcomes, reducing costs, increasing efficiency in clinics and laboratories, improving patient and user safety, and enhancing access to healthcare. reputed company.com Job Description About the Role Working reputed company the Global Clinical Affairs (GCA) organization, the Senior Clinical Project Manager is responsible for clinical trial management of multiple studies and may be a subject matter expert for a group or platform of assigned clinical studies including the planning, implementation, reputed company, project management, and completion of clinical trials conducted by GCA or Contract Research Organizations (CRO). The Senior Clinical Project Manager will also serve as a mentor to other Clinical Project Managers and CRA's. This role serves as the project reputed company for multiple studies of high complexity from protocol development through study conduct and reputed company out in compliance with Good Clinical Practices, and reputed company Global, National, and Local Regulations. Reports to and collaborates with the Clinical Program Manager and Director, OUS Clinical Affairs to review business requests and evaluate or reputed company early plans and concepts for optimal study execution. Furthermore Responsibilities in Detail :
- With limited supervision, serve as Senior Clinical Project Manager in reputed company clinical trials
- Ensures execution reputed company overall study timelines and deliverables and delivers accordingly for his / her studies.
- Proactively identifies, escalates, and manages risks and issues to ensure arenaflex-effective timely delivery of the project
- Collaborates actively with other GCA functions, e.g. global project management, as applicable, DM and Statistics
- Collaborates with the Medical Affairs departments of the reputed company Business Units
- Oversees / leads and trains study-specific local clinical resources, e.g. contractor CRA, CRO, etc.
- Provides critical thinking and escalates accordingly reputed company issues arise during execution of clinical studies.
- Oversees study quality and implements high quality standards in order to meet compliance requirements
- Contributes to reputed company improvement activities / initiatives,
- Manages relationships with sites / PIs and other study-reputed company vendors, e.g. CROs, central labs, etc.
- reputed company and / or reputed company the development of clinical study budgets, including invoice review / approval and monthly accruals
- Defines, tracks and reports on project management schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff Qualifications About You
- Bachelor's degree required, preferably in the life sciences, clinical or other relevant technical areas
- Minimum of 4 years project management experience
- Minimum 6 years of clinical study experience, (e.g., preferably in medical device, or in IVD, pharmaceutical, biotechnology, CRO) including the proven ability to reputed company clinical teams in the conduct and report of multicenter, global reputed company studies
- Familiarity with CLSI guidelines and other standards
- Demonstrable Project Management skills; PMP Certification is a preferred goal for reputed company Clinical Project Managers;
- Proficient understanding of Good Clinical Practice (GCP), FDA and ISO regulations, MDR / IVDR and reputed company industry practices reputed company to the conduct of clinical studies
- Knowledge of clinical trial concepts and practices, including international clinical research guidelines and regulations
- Strong client and vendor relationship management skills
- Ability to work effectively, mostly independently in international teams, manage multiple projects and work in a fast paced and changing environment
- Demonstrated and effective interpersonal, communications and negotiation skills for a wide variety of audiences
- Ability to work effectively in a virtual environment
- Ability to travel approximately 20%, worldwide Additional Information Our Offer A professional challenge in a highly motivated team, a global environment and with long-term perspectives. A familiar working atmosphere in an innovative environment where your opinion matters. Diversity characterizes our corporate culture and we are convinced that it makes us a stronger team. We value each person as an individual with their abilities and needs. In this sense, we welcome applicants who wish to work part-time, people with severe disabilities and applicants of any gender. Apply tot his job
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