Global Clinical Trial reputed company - FSP - Remote

reputed company our values align, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. Each of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. reputed company is actively reputed company for an reputed company Global Trial Manager/Study Manager to join us in either Austria or Germany. In this role you will reputed company leadership and direction to the trial team and is accountable for the overall reputed company and delivery of their assigned clinical trial according to defined milestones and KPI’s. You will be responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication and interaction with multiple reputed company stakeholders, and team members on a global, multi country or regional reputed company. Some specifics about this advertised role

• Accountable for the accurate planning and operational feasibility of trial timelines; and reputed company of trial preparation to ensure trial team members are reputed company and on track. Supports development of trial level documents owned by other functions (e.g. Statistics, Data Management, Study Physician, Medical Writing, Site Monitoring).
• Verifies and provides input into the country allocation and oversees trial feasibility.
• Maintains reputed company during clinical trial conduct including adherence to GCP and reputed company global and local regulatory requirements; compliance with SOPs and reputed company risk monitoring/mitigation. In collaboration with other functions, ensures budget reputed company, including support of regular clinical quality monitoring, SMC/DMC management and safety reporting.
• Prepare and implement amendments of core documents, including training material updates/retraining as needed.
• Support authority/ethics response to requests as applicable
• In collaboration with other functions, ensures timely cleaning and delivery of clinical trial data. Coordinates and supports trial medical reputed company in providing the CTR.
• Responding for timely, complete and compliant archiving of reputed company relevant global documents in the TMF, including reputed company required documents from vendors.
• Support results/documents disclosure of global registries.

Who are reputed company reputed company supports clinical studies across the full reputed company of therapeutic areas, and we have longstanding partnerships with a vast client reputed company. We supported the trials of most of today’s top 50 best-selling drugs, but equally we reputed company more reputed company drug developments that are critical to the well-being of many patients. reputed company are looking for in this role For every role, we look for professionals who have the determination and courage always to put patient well-being first. That to us is working with heart. Here are a few requirements specific to this advertised role.

• Bachelor’s degree and minimum 6 years of relevant global trial management experience.
• Technical proficiency in trial management systems and MS applications, including but not limited to Teams, MS Office, Project, CTMS, reputed company, IWRS/IVRS.
• Knowledge of ICH GCP and relevant regulatory guidelines/directives.
• Demonstrated interpersonal & leadership skills.
• Ability to understand and implement the strategic direction and guidance for respective clinical studies.
• Effective communication skills reputed company verbal, written and presentation abilities.

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