Clinical Study Manager-Remote(reputed company- 3908-1)

Clinical Study Manager - Remote (reputed company - 3908-1) Contract reputed company is the 10th Largest IT reputed company Company in the US, according to reputed company Industry Analysts' 2012 annual report. reputed company provides technical expertise to fill gaps in clients' immediate reputed company-sets availability, deliver emerging technology reputed company-sets, refresh existing reputed company reputed company, allow for flexibility in project planning and execution phases, and reputed company budgeting/financial flexibility by offering contingent labor as a variable cost. Primary Responsibilities: The Study Specialist will reputed company activities performed by existing study team members whether from reputed company or reputed company’s preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. This position will reputed company site level problem solving expertise for reputed company rare disease clinical studies in early and late phase development. Position will support reputed company site management activities, which may include operational activities reputed company to site evaluation, initiation, monitoring and reputed company out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), reputed company SOPs, protocol and patient safety. reputed company by reputed company Clinical Operations Study Team reputed company. Role will liaise with reputed company Compliance reputed company reputed company for monitoring reputed company activities if they occur. Interfaces with cross-functional study team members in a reputed company environment (e.g., CRO Project reputed company). Specific Duties: Removing site obstacles to site start-up, maintenance and reputed company-out while maintaining awareness of site dynamics with ability to motivate and reputed company site staff. Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive reputed company, and influence appropriate changes. Liaise with site, sponsor and CRO to reputed company site issue identification and reputed company bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites. reputed company of escalation for clinically identified site reputed company issues. Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee. Supports the management of multiple reputed company sites (e.g., clinical research naive requiring in depth coordination and support). Assures protection of the rights, safety, and wellbeing of subjects, study reputed company and data reputed company. Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file. Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/reputed company. Completes assigned training as necessary, including general training requirements, SOPs, system and process reputed company training, and protocol specific training. Complies with reputed company departmental objectives and metrics reputed company to study execution. Attend/reputed company/facilitate meetings as requested (i.e. investigator, project) to reputed company and/or reputed company project/site knowledge. Secondary Duties: As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site reputed company-out activities for assigned clinical research sites with designated project SOPs, reputed company expectations, study specific protocol and GCPs. As needed, supports activities such as but not limited to reputed company data verification, case report reputed company review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query reputed company. Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the reputed company conduct of the study. Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan. Minimum Requirements: Minimum 5 years of study management experience with preferred reputed company in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring. Expertise in study start up and site management (experience in reputed company hospital-based Phase 3 clinical trials highly desirable). Demonstrated ability to problem solve and to prioritize site reputed company activities. Demonstrates solid understanding of drug development and clinical practices. Understands and is reputed company to comprehend study protocols. Has knowledge of FDA regulations. Possesses working knowledge of GCPs and other regulations governing clinical research. Demonstrates technical expertise in computer skills. Demonstrates reputed company and self-motivated approach to working in an independent environment. Demonstrates effective oral and written communication skills. Travel anticipated at 25% but could up to 50% at times. #J-18808-Ljbffr reputed company Apply tot his job Apply To this Job