Senior Manager/Associate Director
Job Responsibilities:
1. Plan and deliver the assigned projects with high quality, and in accordance with program/company goal, including project timelines, risk assessments, and budgets etc;
2. Ensure study conduction in compliance with ICH-GCP, country specific regulations, Standard Operating Procedures (SOPs), study specific plans and guidelines;
3. Coordinate project related 3rd party vendors selection (CRO, SMO, central lab etc.) and oversee the vendor performance throughout the study;
4. Manage internal and external clinical development activities with team members involved in the design and conducted of clinical trials;Assists with protocol design and medical issue resolution; Work closely with CMC function to ensure the timely supply of clinical trial drugs;
5. Develop study related documents/plans in collaboration with the CRO, including consent form, protocols, statistical analysis plan, clinical study reports and operational plans, etc.
Qualifications:
1. Bachelor degree or above in life sciences, pharmacy, or medicine related majors;
2. At least 5 years of clinical research or relevant experience; Neurology/pain clinical trials experiences preferred;
3. Fully understand and be familiar with the application of GCP and ICH guidelines;
4. Excellent project management skills with sense of responsibility and teamwork spirit;
5. Good command of English, both in written and spoken, great communication and coordination skills;
6.Demonstrated business ethics and integrity.
E-mail:hr@simrbio.com