Clinical Reseach Manager

Job Description：
• Oversee all operational aspects of multiple clinical researchprograms, to support corporate an******** objectives.
• Provide ******** ******** subject matter expertise an******** toClinical Project Manager, Clinical Research Assoc******** an********Research Organization(s) as needed
• Drive Evidence Base******** Strategies are develope******** executed.
• Ensure clinical research programs are conducte******** accordance withcompany standar******** procedures (SOPs), Goo******** Practice (GCP),an******** country regulat******** as applicable.
• Write clinical protocols for domestic an******** submission.
• Oversee development of project plans, program budgets an********tracking tools.
• Assist in data analysis an******** of clinical reports.
• Develop training materials for clinical affairs personnel.
• Participate in organizing an******** of investigator meetings.
• Oversees an******** in in-country an******** clinical affairs programactivities including but not limite******** CFDA strategy meet********Regulatory CER subm******** preparation an****************
• Ensure appropriate recruitment / selection investigational sites toparticipate in clinical studies.
• Prepare periodic reports for senior management revie********
• Assist investigators in preparation of applicable publications.
• Atten******** procedures to ensure protocol compliance an********device support as needed.
• Serve as technical resource to ******** sales representat********an******** staff members regarding investigational products an********.
• Gather input from cross-functional teams an******** plans that helpthe team produce deliverables on schedule.
• Provide clinical an******** feedback to design an******** groups.
• Assume supervisory responsibility as needed. May be directlyresponsible to manage Clinical Research Associates.
• Recruits staff members, conducts performance appra******** an********other managerial responsibilities as necessary.
• Perform other clinical duties when requested.


Education an********:
• A minimum of a Medical degree or Bachelor’s Degree in Life Science(Animal Sc******** B******** Phys******** Nurs******** MedicalTechnology) plus seven (7) years relevant exper******** which includes aminimum of three (5) years’ experience in medical device/drug clinicalresearch, an******** minimum of (2) years experience managing(indirectly or directly) a professional staff.
• Master’s degree with a demonstrate******** backgroun********preferred.
• Experience with Goo******** Practice (GCP) is required. Knowledge ofGoo******** Practice (GLP) an******** Manufacturing Procedures (GMP)will be an advantage.
• Prior participation in all facets of clinical studies an********supervisory experience required.
• Strong technical or clinical backgroun********.
• Administering successful programs within a timeline
• Effective communication on super******** peer, an******** levels
• Ability to hire quality professionals
• Demonstrate******** to ******** motivate an******** subordinates tomeet objectives

• Effective written an******** communication skills in the area oftechnical/clinical applications. Strong comman******** medicalan******** terminology.
• Demonstrate******** to persuasively influence external medicalprofessionals to ensure project deliverables are complete******** timean******** budget.
• Effective analytical an******** solving.
• Ability to coordinate an******** multiple projects simultaneously.
• Knowledge of CFDA regulations concerning the conduct of pre-cl********clinical studies an******** submissions.
• Knowledge of local, reg******** an******** regulations for clinicalstudies is preferred.
• Effective knowledge in searching medical literature an******** forclinical an******** information.
• Familiarity with biostatistics techniques an******** is an advantage.
• Effective skills in MS Excel, PowerPo******** Wor******** internetsearch engines.
• Excellent computer skills an******** of computerize******** for themaintenance of scientific data.
• Working knowledge of statistics an******** methods.
• Strong comman******** Goo******** Practice (GCP) an******** LaboratoryPractice (GLP) regulations.
• Ability to train others.
• Ability to work with a minimum of supervision.
• Ability to work in a highly matrixe******** environment.