Regional Manager US CFO
Location: , Illinois
Description: Abbott Medical Optics is currently interviewing Regional Manager US CFO right now, this career will be placed in Illinois. For detail informations about this career opportunity kindly read the description below. PRIMARY JOB FUNCTION:
Responsible for the functional management of field based Clinical Research Associates (CRAs). Ensure successful protocol level execution of all Clinical Field Operations (CFO) deliverables for Abbott̢۪s development projects.
This position will be based in the Midwest. Travel Requirements: Up to 40%
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Personnel Management
- Manage up to 15 regionally-based personnel responsible for site identification, qualification, initiation, interim monitoring and study close-out visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Abbott Standard Operating Procedures (SOPs) and business processes.
- Build and maintain a high performance team of regionally based CRAs. Responsible for staff recruitment and retention plans (Abbott employees as well as contract employees).
- Assign monitoring responsibilities to field staff, accounting for complexity of site and study issues and travel limitations.
- Provide ongoing assessment of permanent, contract, and temporary resource needs, and in collaboration with CO management, allocate resources in alignment with Abbott̢۪s research goals and priorities and specific study timelines.
- Provide input to senior management to forecast resource requirements for assigned clinical studies. Identify and communicate issues that impact resource allocation and provide solutions.
- Develop personal training plans, facilitate orientation and training programs, provide coaching, counseling, and feedback, and identify developmental opportunities for assigned region. Plan for succession management for senior positions to ensure monitoring expertise is maintained in region.
- Train field personnel in monitoring techniques and study-specific requirements. Function as a resource for monitoring-related questions and give appropriate guidance.
- Ensure delegated training responsibilities are appropriately and effectively executed.
- Ensure clinical monitoring activities are conducted according to the monitoring plan and are in accordance with project timelines and company objectives. Anticipate and identify issues that could affect timelines and develop alternative solutions.
- Assess risk of issues raised by monitoring staff and understand their potential impact on operational and quality requirements and project timelines. Elevate issues to appropriate Abbott personnel and work to develop a resolution to reduce impact.
- Review and approve monitoring trip reports, ensuring accurate and complete reporting of study conduct. Identify critical issues and bring them to the attention of study management staff.
- Review and approve CRA expenditures to achieve cost-effective operations. Identify avenues to reduce travel expenses in their region and in the overall organization.
- Together with CFO management develop, track and manage performance metrics for CRAs.
- Ensure regulatory inspection readiness at clinical sites in assigned region.
- Develop and implement site management initiatives to maintain enrollment and recruitment timelines.
- Work in partnership with study management staff to resolve critical and complex issues with study conduct at clinical sites. Ensure corrective action is implemented at the clinical site if appropriate.
- Develop and present training monitoring techniques and expectations at departmental meetings.
- Interact with and build professional and collaborative relationships with all study personnel (investigators, study coordinators, pharmacists, etc), peers and office-based personnel. Uses multiple technologies to maintain open and frequent communication with Abbott personnel.
- Identify and partner with other Abbott personnel to develop innovative processes and technologies to increase the quality, productivity and efficiency of CFO and reduce overall operating costs.
- Maintain expertise through clinical and scientific literature review, ongoing awareness of industry practices and participation in professional activities.
- Create a positive work environment by encouraging mutual respect, innovation and accountability at all levels.
The RM is accountable to the Associate Director, Clinical Field Operations. The RM supervises up to 15 regionally based personnel, responsible for recruiting highly qualified personnel, training personnel in effective monitoring techniques and applicable regulations governing clinical research and maintaining the continued performance of reporting staff.
The RM is responsible for the quality of monitoring in their region and the quality and timeliness of monitoring deliverables. They promote professional relationships with physicians and Abbott personnel and look for innovative processes and technologies to increase the quality, productivity and efficiency of CFO. Skills/Experience Requirements The RM is responsible for resolving personnel issues of reporting staff, assessing the risk of site issues raised by their reporting staff and to understand their potential impact on operational and quality requirements of the study and the overall project and to propose alternative solutions. The RM must exhibit a high level of flexibility in an environment that works across multiple therapeutic areas, multiple protocol.
Experience
- Minimum of 7 years of clinical research experience, of which at least two (2) years must be functioning in a lead capacity with mentoring/supervisory/leadership experience, preferably in a field based capacity, and 5 years in clinical site monitoring.
- Strong site management and monitoring skills.
- Experience in multi-therapeutic areas desired.
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Must have advanced and thorough knowledge related to ICH/GCP Guidelines and/or federal regulations, and applicable local regulations.
- Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Excellent communication and interpersonal skills, including situations of conflict resolution, problem solving and crisis management.
- Demonstrated ability to effectively train and mentor others with less experience.
- Exhibit high level of flexibility when facing changes in the work environment.
- Demonstrated ability to manage multiple priorities/projects.
- Demonstrated proactive, positive team player.
- Demonstrated proficiency in the use of personal computers, including a mastery with word processing, spread sheets, email and web-browser applications.
- Working knowledge and experience with electronic data capture systems and clinical trials management systems.
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If you were eligible to this career, please deliver us your resume, with salary requirements and a resume to Abbott Medical Optics.
Interested on this career, just click on the Apply button, you will be redirected to the official website
This career will be started on: Fri, 06 Jul 2012 18:43:22 GMT
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