Senior Manager Clinical Affairs

Job description

Job responsibilities

• Play a key role in the development of company’s strategy for clinical studies to meet business goals and objectives.
• Acting as a key strategic partner to Regulatory Affairs to support regulatory approval of new products and contribute to clinical sections of regulatory submissions
• Responsible for managing resource and study budget to ensure clinical studies are conduced on schedule and within budget while ensuring high quality and compliance
• Build strong and sustaining relationship with investigational sites and investigators for ongoing and future studies
• Work closely with data management to provide guidance on development of case report form (CRF), data cleaning to ensure collection of high quality data
• Work closely with Biostats in study design, developing statistical analysis plan (SAP), analysis, interpretation and synthesis in order to develop Clinical Study Report and /or support development of scientific…
• Ensure compliance with corporate (e.g., SOP’s) and regulatory requirements (e.g., GCP and US FDA regulations and guidelines) and responsible for ongoing review of departmental procedures and process improvement…
• Responsible for setting up effective goals that are meaningful to the department and impactful to the organizations

Job requirements

• Minimum Education: Bachelor’s or Master's degree in scientific field/MD/ PhD with minimum 12 years of professional experience and minimum 3 years of supervisory experience is preferred
• Minimum of 5 years of experience independently managing clinical studies through different study phases (pre-IDE, IDE submission, site selection and activation, study execution, data analysis and study report, and…
• Excellent clinical operation and project management skills, with strong experience collaborating or leading a cross-functional team
• Proven track record of strong cross-functional and key opinion leader management
• Strong experience with clinical study resource and budget management
• Strong experience supporting development of scientific and regulatory strategy for clinical studies
• Strong experience in developing study protocol and other study documents, conducting literature review, writing clinical section for regulatory submission
• Strong knowledge of 21 CFR part 812 , Good Clinical Practice, ISO14155 and other regulations/guidelines.