Clinical Manager
Hopkins MedTech Group DBA Hopkins MedTech Compliance is hiring a full-time Clinical Manager.
Job Duties:
● Oversees the development of clinical trial protocols;
● Participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies;
● Effectively manage daily tasks, provide guidance and oversight related to SOPs, reports, training materials, batch records, materials management, and risk assessments;
● Assists with the development and implementation of clinical projects; Selects qualified clinical sites, conducts site qualification visit and maintain relationship with clinical sites;
● Conducts site monitoring visits and follow-up to detect or assess problems and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies;
● Ensures appropriate transmission of clinical data to the data management department; reviews and analyze case report queries and problems, and clarifies and/or obtains changes to data as appropriate;
● Prepare activity reports to inform management of the status and implementation plans of clinical projects;
● Attend board meetings and participate in new business development.
Job Requirements:
Master's Degree in Health Administration, Medicine, Biology, Chinese Medicine, Acupuncture or other related field. Must have 1 years’ experience as clinical manager, medical manager, clinical research associate or other related position. Must have experience with developing standard of procedure, project feasibility evaluation and budget control, and clinical trial monitoring; Knowledge of FDA regulations and guidance.
Any applicant who is interested may submit resume w/code HMG23 to: Xiaohui Wu, Hopkins MedTech Group , 233 Mt Airy Rd 1st Floor, Basking Ridge, NJ 07920.
Job Criteria:
Position Type: Full-Time Permanent
Education Required: Master’s
Experience: 1 year
Contact Information:
Contact Name: Xiaohui Wu
Company: Hopkins MedTech Group.
City: Basking Ridge
State: NJ
Zip: 07920