Senior Clinical Trial Manager, Clinical Operations (439149)
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OVERVIEW:The Senior Clinical Trial Manager, Clinical Operations will be responsible for the operational management and oversight of clinical trials within a clinical development program. The position will work closely with the Medical Monitor and other cross-functional representatives including Clinical Data Management, Biostatistics, Regulatory/QA, Pharmacology and Biology to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget. The position will also provide oversight of the CRO and other third party vendors on the assigned study. This individual will report into the Director, Clinical Operations. Responsibilities: Oversee performance of CROs, third party vendors, and field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate within Client and/or CRO as appropriate Perform clinical data review of data listings and summary tables, including query generation Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits Develop and maintain good working relationships with investigators and study staff Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures Track and report on progress of study including site activation, patient enrollment, monitoring visits Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience) Investigate queries, monitor discrepancies Manage investigational product (IP) accountability and reconciliation process Responsible for review or approval of IP release packages Negotiate and manage the budget and payments for investigative sites, if applicable Write or contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work Assist with CRA and third party vendor training on protocols and practices Actively provides operational direction and/or general supervision to subordinates Requirements: 8 years Clinical operations experience or a combination of education and relevant work experience in the pharmaceutical industry Bachelor s degree or equivalent Working knowledge of GCP/ICH guidelines and the clinical development process Global Phase III experience in cardiovascular or oncology drug development desirable Experience in leading industry sponsored clinical (pharmaceutical) trials Cross-functional team leadership experience Management of international clinical studies highly preferred Experience managing vendors, including performance assessments and total financial management (invoice review, change order management, budget reforecasting) Previous experience working with an electronic data capture system and CTMS system required Proficient with MS Word, Excel and PowerPoint. Experience with MS Access and MS Project a plus Strong interpersonal, communication (written and verbal), and organizational skills Demonstrated ability to work independently as well as part of a multi-functional study team Able to motivate a team to work effectively under a changing environment Able to solve problems under pressure Self-motivated and able to work effectively in a matrix/team environment Availability for potential travel domestically and internationally
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