The Associate Director, Clinical Review will provide senior leadership for the Clinical Review Department (Clinical Reviewers, contracted Clinical Reviewer(s) and CEC Operations staff) at the Company with management oversight responsibility for all Clinical Review Services. The Associate Director will work effectively with all Company department heads, support centers and Project Managers to provide coordinated project based services and incorporate Clinical Review based processes into other Company systems. He/She will work with the project teams and Business Development to respond to requests for proposals requested by clients. The scope of this position requires a thorough understanding of all clinical trial processes from proposal through final study report and the ability to identify and implement business process changes necessary for successful Clinical Review services. The essential functions of this position will include: being responsible for the operational day-to-day management of the Clinical Review Department and Clinical Review services within the Company; maintaining responsibility for Clinical Reviewers, contracted Clinical Reviewer(s) and CEC Operation staff activities; working closely with the Senior Program Director of CEC Client Services in order to assist with the oversight, resourcing and clinical management of all CEC limited Service projects; being responsible for the selection, management and professional development of all staff within the clinical review and CEC Operations team(s) (this includes conducting performance reviews, hiring, performance improvement plans, etc.); being responsible for the maintenance and development of all Clinical Review Department SOPs and their harmonization with other operations within the Company; being responsible for the development of appropriate quality control procedures relating to work product and Clinical Review processes; facilitating process change mapping where necessary to improve efficiency within Clinical Review; actively participating in the preparation and conduct of the Clinical Event Committee meetings- attendance would be required on an ad-hoc basis; and overseeing project resource allocation and project timelines for Clinical Review. The Associate Director, Clinical Review will also actively participate in necessary management meetings, and committees representing the Clinical Review Department; developing and fully utilizing the leadership abilities and expertise of the Senior Clinical Review personnel to effectively work together with other Company Directors, Departments and support cost centers to promote an effective and collaborative professional services organization; interface with the Medical Director of Medical Affairs and Executive Director, Clinical Investigations as necessary; troubleshoot operational issues involving the Clinical Review department activity with associated personnel at the Company; develop action plans to address problems which may arise; assist with the oversight and integration of third party EDC systems when specified by clients, using understanding of Clinical Review processes to blend third party functionality and efficacy; prepare and present status reports as well as communicate relevant issues from the department to relevant senior management; develop and maintain appropriate training systems to assure the consistent performance of all professional staff in the conduct of their jobs including workflow, SOPs and GCP; and perform other tasks as assigned. He/She will also perform administrative functions within the Clinical Review Department including: interfacing with technical and clinical staff both in-house and with clients (i.e., from pharmaceutical, biotech and device companies); supporting new business development activities by presenting clinical review services under management, reviewing, approving and participating in research proposals and budgets; working with Senior Program Director, present and represent clinical review at client presentations, bid/proposal defenses and other pivotal ad-hoc meetings as assigned; working with management, participating in the identification of department goals, and assisting in planning, implementing and evaluating the progress in meeting the yearly goals; acting as a resource to department members in identifying, documenting and implementing their individual performance goals based on the Company and department goals; evaluating attainment of performance goals on an annual basis, or more often as needed; working with management, participating in the creation and monitoring of department budgets; and assisting employees in identifying resources available to increase productivity or gain additional industry knowledge.
A Medical degree in Health/Science (R.N and /or MD preferred, MBA/MA desirable) and a minimum of 10 years of clinical trial experience in pharmaceutical, medical device companies, clinical research organizations or teaching hospitals, a minimum of 5 years of direct management experience, and experience in budget and operational management are required. The successful candidate must also possess the following: ability to be detail oriented, strong project management, organization and prioritization skills; excellent leadership, presentation and communication skills; ability to work effectively within a team environment; ability to manage multiple priorities/projects and maintain professionalism in stressful situations; excellent planning, coordination, and supervisory skills; strong process focus and expertise in process definition and improvement; and proven facilitation skills and the ability to arrive at consensus among competing stakeholders. Working knowledge of the pharmaceutical, biotechnology and/or medical device clinical trial data management and processes, including the regulatory requirements of 21 CFR Part 11 and familiarity with multiple EDC systems would be helpful.
On Assignment - 13 months ago
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