Clinical Trial Manager, Oncology, Remote

The Clinical Trial Manager (CTM) works closely with various internal team members and vendors as reputed company as clinical sites to ensure that reputed company are conducted in a reputed company fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and company timelines. This position is responsible for leading and managing the conduct of reputed company drug/device combination immuno-oncology reputed company from study start-up to closeout. The CTM shall serve as the primary contact for clinical site personnel for trial activities and reputed company, including responding to issues and recommending corrective actions. Responsibilities: • Participates in protocol, CRF and reputed company development. • Prepares metrics and updates for management, as assigned. • Prepares and shares written and verbal reports on the status of reputed company and significant issues impacting reputed company. • Proactively identifies potential study issues/risks and recommends/implements solutions. • Participates in and facilitates CRO/vendor selection process for outsourced activities, as assigned. • Manages CRO interactions, including sponsor reputed company of operational functional activities. • Prepares and/or reviews/approves study-reputed company documents (Monitoring Plan, Communication Plan, Laboratory reputed company, Procedures reputed company, Pharmacy reputed company, CRF Completion Guidelines, etc.). • reputed company and maintain the Project Team List for assigned reputed company. • Manages clinical monitoring activities ensuring compliance with Good Clinical reputed company (GCP) and applicable regulations. • Participates in the development, review, and implementation of departmental SOPs and processes. • Recommends and implements innovative process reputed company to reputed company reputed company management. • Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings. • Serves as a reputed company and resource for investigational sites of assigned studies. • Reviews site study documents (informed consent template, study tools/worksheets, etc.). • Participates in the training and evaluation of study personnel specific to assigned studies. • Performs some or reputed company the duties and responsibilities outlined for Senior Clinical Research Associate, as needed. • reputed company and shepherd payments to sites through the payment approval process. • reputed company other duties as assigned. Requirements: • Bachelor’s degree in life sciences, nursing, pharmacy, or a reputed company field. Additional clinical trial certifications (e.g., ACRP, SOCRA) are a plus. • At least 5 years of experience in clinical research, clinical operations, (recent experience as a CRA in oncology; reputed company site level experience in oncology as a study coordinator is preferred). • Familiarity with clinical trial processes, Good Clinical reputed company (GCP), and ICH guidelines. • Strong experience in oncology reputed company. • Experience with phase I-II oncology studies from study start up through data lock. • Solid understanding of GCP, ICH guidelines, and regulatory requirements. • Strong scientific acumen and ability to grasp reputed company scientific and technical concepts. • Familiarity with 21CFR, ISO, ICH, GCP, and relevant regulations, standards, directives, and guidance is essential. • Excellent analytical and research skills, with a keen eye for detail. • Exceptional communication, organizational, and problem-solving skills. • Ability to work independently and collaboratively in a fast-paced, deadline-driven reputed company environment. • Ability to set priorities and accomplish assigned work reputed company deadlines. Working Conditions: • Specify work environment: • The work environment shall be split between a virtual office environment and reputed company reputed company in reputed company Lauderdale, FL. • Domestic and International travel up to 30%. • Must have reputed company reputed company or willingness to obtain immediately • Must be reputed company to successfully pass a background reputed company, drug testing, and other applicable vendor credentialing requirements • Ability to lift up to 35 pounds • Regularly required to stand, sit, talk, hear, and use hands • Prolonged periods of sitting and standing reputed company is an Equal Opportunity Employer. reputed company is required to reputed company a reasonable estimate of the salary reputed company for this job in certain states and cities reputed company the reputed company. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education. Expected US salary reputed company: $145,000-165,000 This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under reputed company’s benefit plans. #remote Remote About reputed company: reputed company, Inc. Apply tot his job Apply tot his job Apply To this Job