Clinical Trials Manager - Acerta

AstraZeneca Pharmaceuticals LP Redwood City, CA

About the Job

Acerta Pharma is a leader in the field of covalent binding technology and is applying this technology to create novel, highly selective therapies for cancer. In February 2016, AstraZeneca acquired a majority share of Acerta Pharma via a USD $4 billion investment and is a committed partner to the development of these innovative drug candidates. Acalabrutinib is Acerta's lead program which was developed based on our discovery efforts. It is an investigational covalent Bruton tyrosine kinase (BTK) inhibitor currently under investigation in multiple Phase 3 clinical trials. The clinical program includes over 20 trials in hematologic malignancies and solid tumors. Over 1,800 patients have participated in these trials to date. The Clinical Trials Manager will lead activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and vendors. Coordinates the training of staff involved in clinical trial management. Provides training to clinical operations staff and performs performance appraisals of direct reports. The Clinical Trials Manager is responsible for the preparation and finalization of project and study-related documents including informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required. The selection of investigators and study sites. Identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor. Coordinates the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT. Ensures that CRF data queries are resolved. Coordinates and manages Investigational Product including overall accountability and reconciliation. Responsible for the preparation of study budgets and timelines. Manages project timelines and vendor performance to meet departmental and corporate goals. Manages study budget and payment process for all clinical trial vendors including investigative sites. Monitors and tracks clinical trial progress and provide status update reports. Manages all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG). Additionally, the Clinical Trials Manager is responsible for selection of CRO study staff and coordinating training including documentation. Hires, trains and oversees study Field Monitors (e.g., review of all trip reports) and provides guidance on site issues. Leads with minimal supervision in the planning of investigator meetings and making presentations, as required. Leads the review of clinical data at the CRF, data listing, and report table levels. Represents Clinical Operations at the Project Team level for individual studies, as appropriate. Partners with other research and development groups to achieve deliverables. Participates in Site Initiation Visits (SIVs) as required. Co-Monitors regional sites for adherence to protocol and GCP as required. Identifies and escalates site, vendor and study related issues to supervisor, as appropriate. Participates in clinical and department settings, including attending additional meetings as required, and interacts in a positive and professional manner. Supervises Clinical Trial Assistants and Clinical Research Associates, and conducts performance appraisals. Performs other duties as assigned and travels nationally/internationally as required up to 30% of the time. Required: * Demonstrated expertise in relevant clinical operations activities * Ability to exercise independent judgment within generally defined practices and policies that lead to methods or processes for obtaining results * Good organization and planning skills * Strong interpersonal skills and communication skills (both written and oral) * Ability to problem solve and delegate appropriate tasks to subordinates * Knowledge of ICH/GCP guidelines and FDA regulations * Strong leadership skills, self-motivated, adaptable to a dynamic environment * Ability to collaborate effectively with the study team, cross-functional team members, and external partners * Knowledge of ICH/GCP and FDA regulations * Proficiency in MS Word, Excel and PowerPoint Education/ Training: * BA/BS/MS in a scientific discipline * 4+ years of relevant clinical experience in a CRO or pharmaceutical industry * At least 3 years of CRA experience and 2 years of study management experience * Experience in oncology preferred * Experience in global trials preferred Next Steps -- Apply today! To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience -- it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them. AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised. ~bsp