主要职能 Primary Function:

The Senior IT Business Analyst will oversee the planning, implementation, and tracking of IT projects related to clinical development . The ideal candidate will have extensive experience in the pharmaceutical industry, particularly in clinical trials, pharmacovigilance, and regulatory affairs related systems. Candidate will be responsible for analyzing business processes, identifying improvements, and ensuring the effective implementation of IT solutions to meet the needs of our clinical development function.
主要职责 Major Responsibilities and Duties:

• Identify new system demand by fully understanding business objective, business requirement, standard and regulation.

• Develop and propose IT solutions that enhance efficiency, compliance, and data integrity in clinical development.

• Act as IT PM role for conducting application implementation project including evaluation of capability of vendor, product and service, coordination with vendor and clinical development function.

• Plan, schedule, and track project timelines, milestones, and deliverables.

• Define project scope, goals, and deliverables in collaboration with senior management and stakeholders.

• Operate and maintain clinical systems, ensuring they meet the operational needs and compliance standards of the organization.

• Provide supporting on validation, testing and installation for clinical development system.

• Identify root cause of application problem and avoid recurrences.

• Design, develop and provide user training for responsible systems, including maintaining training manuals.

• Draft and submit budget proposals and recommend subsequent budget changes where necessary.
任职要求 Qualifications:

Skills:

• 3+ years of experience working in a pharmaceutical or regulated environment.

• Have experience working in regulated environment.

• Hands-on experience in implementing, management clinical systems

• Specific system administration experience in clinical development, RA and PV business is a plus.

• Excellent analytical, problem-solving, and communication skills.

• Ability to work collaboratively in a cross-functional team environment.

• Good understanding of Pharma regulations (NMPA/FDA/EMA) and guidelines (GAMP)

Education:

• Bachelor’s degree in computer science or relevant

• Good spoken and written English skills.
Base location:

Shanghai

其他信息
语言要求：英语、普通话
行业要求：全部行业
所属部门：IT