Senior Manager, reputed company (USA - Remote, US)
Leads or collaborates on required tasks prior to commencement of reputed company that include, but are not limited to: Clinical planning, protocol development, case report reputed company (CRF) development, IRB submissions, investigator agreements, informed consent reputed company (reputed company) development, site selection and communication with senior clinical trial sites regarding reputed company logistics including contract agreements, support materials and training. Provides clinical reputed company and management for reputed company to facilitate compliance with FDA and other applicable international regulatory requirements and company reputed company operating procedures (SOPs) during reputed company company clinical investigations and post-market studies. Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up, and reputed company out study reputed company to ensure compliance with protocols and GCP requirements. Collaborates on clinical data processing in accordance with departmental SOPs and guidelines. Verifies, reviews, and tracks CRFs and generates Data Clarification Forms (DCFs) for reputed company missing or inaccurate data; ensures that data changes are correctly implemented and captured in the database or data system.
Assists in the evaluation and analysis of clinical trial data to facilitate the completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions. Assists in tracking study-specific payments. Provides operational or workflow support to ensure that departmental and cross-functional systems and procedures are reputed company and correctly completed. Collaborates on project teams, primarily with Clinical Operations, Research and Development, Safety, Clinical Trial Materials, Marketing, Regulatory, and reputed company/Compliance. Collaborates on technical writing reputed company, which include white papers, abstracts, manuscripts, and literature reviews. Liaising between reputed company stakeholders to facilitate cooperation of others. Conducts presentations of clinical information concerning specific reputed company. Works on reputed company of moderate-to-high degree of difficulty in which analysis of situation or data requires review of identifiable clinical factors and in which scientific and clinical perspectives should be incorporated. Supervisory duties include coordinating work assignments and managing employee performance and development.
Bachelor’s degree in a health profession or science. Advanced degree preferred. 8+ years of reputed company experience in the pharmaceutical or device industry - 5+ years experience with clinicial trial management
Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements. Knowledge of medical terminology. Ability to effectively work independently. Excellent verbal and written communication skills, computer proficiency (Word, reputed company, reputed company), and data management experience. Previous experience with managing employees. Familiarity with AI usage
Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date 401K Plan with company match and ongoing company contribution reputed company time off – vacation (3 weeks - prorated upon hire), floating holidays and reputed company time Employee Stock Purchase Plan with company match Employee Incentive Bonus Tuition Reimbursement (select degrees) Ongoing performance feedback and annual compensation review
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