Medical Research Project Manager

Medical Research Project Manager

J&J Retail
3-6 years
Not Specified

Job Description

. Plans and monitors clinical research projects which includes study start, development of case report forms, informed consent, overall project management and communication . Reviews research results, evaluates the safety and medical usefulness of the clinical device . Reviews the draft protocol and oversees documentation needed for data collection and analysis . Assist with interpreting the clinical results in preparing for communication to the appropriate internal and external stakeholders . Execute studies from start to finish and monitor the process against clinical research guidelines and safety procedures . Maintains expertise and understanding of clinical trials documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies, and process . Evaluates results that are necessary to determine the safety, efficacy, and medical usefulness of device candidates. Communicates and reports detailed outcomes and results of research findings to relevant groups . Handles project budgets and projections . Reviews and monitors relevant registration, submissions, and reports . Assists in mentoring of colleagues . Partners with the clinical operations team, KOLs and other JNJ departments . Support medical research team members, providing input to study design, risk analysis and clinical consultation relative to therapeutic area . Train site personnel to ensure compliance with study requirements . Maintain audit/inspection readiness at assigned sites throughout the conduct and upon closure of clinical trials at assigned investigative sites Qualifications . Minimum of a Bachelor's degree is required. . Minimum of 3+ years of clinical research experience with independent field monitoring experience a must, experience in post authorization studies, RWE, clinical registries a plus. . Knowledge of Janssen DAS is preferred. . MNC or CRO industry experience is preferred. . Strong knowledge of GCP, specifically as it applies to investigative site conduct of clinical trials, is required. . Ability to successfully balance multiple priorities and adapt quickly to changing priorities. . Ability to problem-solve is required. . Effective communication via written, verbal and listening skills, with ability to effectively deliver training and educational presentations. . Proficiency using MS Word, Excel and PowerPoint is required. . Ability to travel up to 20% approximately domestic is required. Primary Location China-Beijing-Beijing- Organization Xian-Janssen Pharmaceutical Ltd. (7043) Job Function R&D Requisition ID 2105964807W

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