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Responsible for supporting under the leadership of the Clinical Trial Leader (CTL), all aspects of clinical tri-al(s) (phase I through lifecycle management) as assigned. Recognize potential challenge within the protocol and operational aspects of the trial and escalate to Clinical Trial Leader (CTL) as appropriate and develop appropriate actions with the CTL. Assist CTL in the development of trial execution plan and support trial feasibility. Responsible for tracking CRO activites and milestones and holding CROs accountable for meeting these milestones on time and within budget as agreed in the contract/Schedule of Work. Train CRO field monitors on the protocol and key trial elements together with CTL for performing site selection. Maintain a strong knowledge of the protocol to be able to answer standard operational questions from CRO field monitors and sites. Review site selection reports and recommend list of sites for trial participation to Clinical Trial Team (CTT). Develop and implement site management oversight plan. Work with CRO field monitors and ensure that all essential documents are in place for approval of site initiation and initial/subsequent IP release to sites. Provide training as needed to the CRO field monitors and any other activities that support site readiness to recruit. Ensure documentation of training is archived appropriately. Monitor the progress of site initiation and review site initiation reports. Ensure monitoring visits are performed by CRO field monitors according to the monitoring plan. Review monitoring visit reports to identify quality/compliance issues that require escalation to CTL and/or require follow-up with the CRO field monitors for resolution with the sites. Perform co-monitoring visits with the CRO field monitors as needed. Perform periodic review of issues to identify any trends for communicating and taking appropriate actions with CTL. Classify the impact of the trending with CTL and/or CQA if applicable. Provide governance on country and site-specific TMFs maintained by the CRO. Communicate with CRO field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics. Serve as main contact to CRO field monitors for any potentially significant quality/compliance issues and escalate to CTL team as required. Attend and participate in clinical trial team meetings. Review and communicate with CRO field monitors to ensure timely CRF data entry and resolution of data issues by the sites. Ensure that all trial close?out activities are performed, in close cooperation with CRO field monitors and CTL. Facilitate internal audits and HA inspections as required. The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelor's degree or equivalent qualification in life science/healthcare is required if no previous experience in clinical research or Associate degree or equivalent qualification in life science/healthcare required if accompanied by 4 years clinical trial experience. Bachelor?s degree or equivalent qualification in life science/healthcare, Master degree is preferred. Excellent English (oral and written). Fluent in at least one other language. At least 5 years pharmaceutical industry experience with 3-5 years strong experience in clinical research in a field monitor role in addition to a role overseeing clinical trials. Srong Interpersonal skills. Strong Project Management and leadership skills. Working experience in a global team, team player. Ability to work under pressure. Ability to work in a matrix environment. Displays innovative ideas and solutions. Highly proficient in negotiation skills.