Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks.
We seek an Associate Director, Clinical Trial Management to:
Job Duties include:
• Partners with Clinical Operations management to develop staff, structure department, and create a highly desired work environment for attracting and retaining highly qualified clinical operations professionals
• Oversees tactical implementation of the clinical development plan by managing the timeline, resources, budget, and staff of clinical activities
• Guide study team in vendor selection and provide management oversight throughout the life of all assigned clinical projects. Proposes vendors for approval.
• Ensures operational feasibility of clinical development plans and scenarios, including time, budget, and resource requirements.
• Analysis of protocol to produce investigational product (IP) forecasts, identify IP import and regulatory issues, IP distribution and storage requirements and IP labeling requirements.
• Work with senior management to develop and to achieve corporate goals and work with clinical operations staff to achieve the established corporate goals within the expected time frames.
• Manages and leads the day-to-day clinical trial activities related to the development and execution of cross-functional and third-party vendor activities and deliverables, including but not limited to, development and/or review of clinical data management conduct (e.g. eCRFs, CRF guidelines, edit check specifications, database build, query resolution and database cleaning), relevant study plans (e.g. monitoring, study operations, quality, communications, etc.), protocol review for operational feasibility and consistency, tracking site selection and activation and patient recruitment and tracking to project timelines
• Clinical operations leader and main point of contact with counterpart at outside vendor, CRO and/or trial sites; daily review and identification of potential issues or problems and communicates/escalates to CTL/Project Team
• Develops, maintains and promotes, effective and collaborative working relationships with and among internal team members and external vendors and 3rd party personnel to develop team esprit de corps
• Participates in Clinical Operations initiatives and programs as assigned, including identifying areas of best practice and recommends process improvements, development of SOPs and department level training and cross project initiatives
• Prepare and maintain Trial Master Files (TMF) for multiple studies, ensuring tracking of ICH-GCP and/or FDA CRF21 essential study documents. Inform the CTL/Project Team on any outstanding document/s
• Develops knowledge of sample collection and analysis process at the study level and may perform reconciliation and/or tracking of sample manifests
• Lead reviews of key data to identify trends, discrepancies, errors etc. to ensure ongoing quality of conduct in accordance with the protocol and vendor contracts, including on-going review of emerging data for tables, listings and figures
• Performs in-house review of site monitoring reports and tracking to ensure appropriate monitoring of trial conduct and satisfactory resolution of outstanding issues
• Develop and maintain tracking spreadsheets with study level information to enable accurate and efficient supply of clinical drug product (IMP) and clinical supplies to Sites, Vendors and CROs
• Support financial oversight of clinical studies through invoice tracking and reconciliation for potential change orders
• Tracking of patient and recruitment status using applicable spreadsheets and web portal tools
• Assist in the critical development and review of key study documents (eg, Protocol, ICF, study plans, eCRF etc.)
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
• Expert time management and organizational skills
• Excellent attention to detail and accuracy in work, with a strong work ethic, willing to put in the time and effort to complete critical tasks on time with quality
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Expert knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials
• Computer skills including proficiency in use of Microsoft Outlook, Word, PowerPoint and Microsoft Project
• Must think critically and creatively and be able to work independently to determine appropriate actions to resolve complex problems
• Bachelor’s or graduate degree in a field of science or nursing, preferably biology, chemistry, or pharmacy. A minimum of 8 years clinical operations experience, with at least 5 years in clinical trial management
We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume. For further information about Xencor, please visit our website at www.xencor.com EOE
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