>>>Location：Shanghai
---Responsibilities---
【Clinical Trial Leadership】
·Serves as the focal point of communication between internal and external clinical research partner throughout study implementation, execution and closure.
·Capable of managing multiple medium to large/complex clinical trials. Lead project feasibility and sites allocation.
·Independently or with limited supervision from mentor/line manager, responsible for planning and execution of trial deliverables, including but not limited to:
·Scope and Budget：
a).Understand the scope of work required and budget components. Monitor the status and make changes (per change control process) as needed to meet the deliverables of the trial.
b).Using financial tracking tools to establish and monitor trial budget (grant and non-grant). Verify, approve and track external service provider/site payments.
·Timeline：
a).Drive overall trial timeline and gain endorsement from senior management team.
b).Inform all stakeholders (internal and external) agreed timeline, assure trial execution (e.g. site initiation, subject enrollment, interim analysis, DBL, CSR) on target.
c).Capable of using timeline management tools to set baseline, track and adjust timeline with inputs from trial team.
·Quality and Compliance：
a).Maintain familiarity with regulations and guidelines regarding clinical trial execution practices, comply with all regulatory requirements, legal, financial, SOPs.
b).Achieve project quality by identifying quality risks and issues, responding to issues raised by project team members and planning/implementing appropriate corrective and preventative action plans.
c).Ensures inspection readiness and provides consultation and support for any type of audit, ensures adequate and timely CAPA follow up.
d).Secure (e)TMFs, ISF completeness and quality.C3
·Actively coordinates, participates and presents in investigator meetings, SIVs as required. Drive project meetings, facilitate trial training planning and implementation.
·Participate in the negotiations and the selection process of external service providers (ESPs), cordinate bidding, Provide inputs for ESPs quotations. Oversight of ESPs performance.
·IP lifecycle management including developing IP supply plan, label, package design, IP return and destroy. Coordinate IP complain management.
【Scientific Expertise】
·Provide operational strategic input to protocol development.
【Process Excellence】
·Act as a subject matter expert in specific area.
---Qualification---
·Bachelor’s degree or above in clinical medicine or related medicine.
·Familiar with the medical programs and clinical studies of innovative drugs at all stages, and oncology related background is preferred.
·At least 5+ years of clinical experience in a foreign company or a large CRO company.
·Familiar with CFDA and FDA drug R&D laws, regulations and policies.
·In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines. Good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
·Good communication, team management and executive management skills.
>>>Contact Information：
联系人：Frank Wang
联系方式：15680922101（微信同号）
邮箱：frank.wang@isaac-kenneth.com
