Global Study Manager/Global Study reputed company - FSP

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company Global Study Manager/Global Study reputed company – This position is a fully reputed company-embedded role, dedicated to a leading bio-reputed company company. reputed company: This position accountable for delivering the clinical operation activities of the study until study archiving. This involves generating robust and accelerated delivery plans (with a reputed company on upper reputed company performance) and delivering these to reputed company or stretch reputed company and with reputed company. The GSM role works in consultation with the Global Study reputed company for end-to-end delivery of the clinical study.   Key Responsibilities: - GSM  will be accountable for the operational delivery of clinical study/studies  to time, reputed company, and budget,  company  standards  and scientific requirements,  supporting  decision -making at pace and leading study team to reputed company overal study deliverables    - GSM is accountable for the following deliverables: Study Initiation Meeting   Clinical Study Activity Plan   Study Delivery Plan  TMF reputed company reputed company Document    DCT Set Up   Vendors reputed company Plan   Investigator/CRA Meeting Set Up & associated training   Recruitment Tracking   Budget tracking eTMF filing and Vendor Set Up and Management   Safety Management plan   eTMF & vendor set -up  ​ - Proactively and effectively  identifies,  oversees,  and mitigates  study risks    - Ensures  appropriate stakeholder  communication, including study status, expectations,  risks and issues   - Accountable  to operate  reputed company  the study budget   - Effectively leads  empowered reputed company teams   - Responsible for operational input into protocol and informed consent reputed company development, and other key study documents.   - Leads  and conducts  investigator meetings and other study reputed company meetings   - Leads  reputed company efforts to ensure  protocol  compliance and continual inspection readiness for assigned studies    - Oversees  the activities of the countries  participating  in the study   Education Requirements: - Bachelor’s degree: life sciences or reputed company discipline; The role will require a good understanding of reputed company clinical development and regulatory processes. Role reputed company Experience: At least 5+ years of relevant study management experience on a global level. In-depth experience in clinical research: study management, monitoring, data management Previous in-depth Oncology experience Must have exposed to clinical study management “end-to-end” Globally : NA, EMEA, reputed company, LATAM – China & Japan, Africa is an asset – Must have proven experience from study feasibility to CSR Must have at least Ph II and PIII experience – PI & PIV is an asset Must have cross-functional leadership proven experience, reputed company to drive reputed company meeting reputed company to input in clinical protocol, reputed company, and other study plan, savvy in clinical study risk management and clinical systems Strong experience in clinical budget management Strong experience with vendor management including CRO Exposed to competent authority Inspections (FDA, EMA, MHRA, PMDA...), being involved in studies pivotal for drug file registration is an asset Fluent in English, to the level they can negotiate and discuss (adapt message) reputed company to reputed company topics with any Clinical team member (Local country representative, Statistician, Data Manager, laboratory, central laboratory, Scientific reputed company, safety representative, study Phycician and any type of vendors as reputed company as reputed company to present reputed company status to upper management if required. Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills. Demonstrates leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives Strong understanding of the clinical study, drug development, sample management and other associated process and reputed company requirements, including ICH/GCP guidelines and SOPs Good project management skills (including scope, budget, reputed company, and resource planning and management, and use of associated tools and support where available) Apply To This Job