Location:Redwood City, United StatesJob reference:
Sep. 14, 2016
Acerta Pharma was established in 2013 with a mission to discover and develop novel targeted molecules with the potential to improve patients' lives. At the core of our vision is a foundation based on cutting edge technologies, which enable the development of specific and selective drug candidates. Acerta's innovations translate to more effective and less toxic prospective therapies. As a member of the AstraZeneca group, Acerta is well positioned to rapidly achieve its first of hopefully several drug approvals to come.
The Clinical Trials Manager will be 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, for the selection of investigators and study sites, and for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor. You will coordinate 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.
In addition, the Clinical Trials Manager will ensure that CRF data queries are resolved, coordinate and manage Investigational Product including overall accountability and reconciliation, and be responsible for the preparation of study budgets and timelines. You will manage project timelines and vendor performance to meet departmental and corporate goals, study budget and payment process for all clinical trial vendors including investigative sites, and you will monitor and track clinical trial progress and provide status update reports, as well as manages all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG).
* BA/BS/MS in a scientific discipline
* Four or more years of relevant clinical experience in a CRO or pharmaceutical industry
* At least three years of CRA experience and two years of study management experience
* 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
* Knowledge of ICH/GCP guidelines and FDA regulations
* Knowledge of ICH/GCP and FDA regulations
* Proficiency in MS Word, Excel and PowerPoint
* Experience in oncology
* 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
* 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
* Experience in global trials
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.