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This role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally, a key role to monitor and direct project planning, deliverables, budget, resources, as well as risk assessment and management for assigned projects across all phases of global/local development projects. Provide a key support role to Medical Director (MD) to effectively run clinical study team, and act as the POC between sponsor and outsourcing vendor(s) to manage local/regional or global projects.
Responsibilities include, but are not limited to:
? Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet commitments from feasibility and site selection, recruitment, execution and close out.
? Main Point of Contact (POC) for assigned protocols and link between Clinical Operations and Clinical Trial Team (CTT).
? Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.
? Reviews Monitoring Visits Reports and escalates performance issues and training needs to functional vendor and internal management as needed.
? Performs Quality control visits as required.
? Leads study teams to high performance: closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different roles in internal and external teams ensuring a strong collaboration.
? Responsible for creating and executing a local risk management plan for assigned studies.
? Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
? May support MD with oversight of Therapeutic Area program(s) and strategy alignment as needed.
? Escalates as needed different challenges and issues to MD and or CTT (as appropriate).
? Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.
? As a customer-facing role, this position will build business relationships and represent our company with investigators and medical centers.
? Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with MD, BD and other line functions.
Qualifications & Skills:
? Expertise in project and site management. The position requires demonstrated successful implementation of project management skills at program and site level.
? Strong organizational skills with demonstrated success required.
? Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined strategies.
? Requires a complete understanding of ICH, GCP and global and local regulatory environment.
? Strong scientific and clinical research knowledge is required. Including extensive knowledge of regional and/or country clinical trial landscape.
? Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and execute complex protocols simultaneously.
? Experience functioning as a key link between Sponsor and Clinical Research Organizations, or other outsourcing vendors.
? Ability, experience, and skills to proactively manage resource allocation, processes (and controls), productivity, quality and project and/or program delivery.
? Oversee Therapeutic Area strategy alignment and consolidate relevant information, within specific indications.
? Proficiency in written and spoken English and Mandarin. The incumbent must be competent and effective in written and verbal communication.
? Strategic thinking.
? The position requires proven strong project management skills and/or project management certification or relevant training program.
? High emotional intelligence.
? Ability to focus on multiple deliverables and protocols/projects simultaneously.
? Exercise strategic thinking and executes effectively across projects.
? Ability to identify problems, conflicts and opportunities early and lead, analyze and creatively prepare mitigation plans and drive conflict resolution is critical.
? Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include:
? 1) low patient recruitment,
? 2) inadequate staff to meet business needs,
? 3) performance or compliance issues,
? 4) working with regulatory issues and the broader organization, and
? 5) resolution of conflictive situations.
? Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.
Education & Experience:
? Bachelor degree or above, 5+ yrs Pharmaceutical R&D
? Experience in the therapeutic area of Ophthalmology is preferred.