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WHAT
IN
MANAGER CLINICAL COMPLIANCE
Job
Global Pharmaceutical R and D
US
-
Lake County,
Illinois
Job Code - 69978BR
Position - Full-Time/Consider Job Share
Job First Active on: Thursday, November 05, 2009
APPLY TO THIS JOB (You will be applying directly to Global Pharmaceutical R and D for this position!)
JOB DESCRIPTION: MANAGER, CLINICAL COMPLIANCE
PRIMARY FUNCTION / PRIMARY GOALS / OBJECTIVES:
The Manager of Clinical Compliance evaluates implementation and compliance for key Clinical processes/procedures and requirements through:
• The collection, analysis and reporting of Clinical compliance metrics.
• Compliance checks/assessments to assure the implementation of process/procedure/form changes.
• Compliance checks/assessments of key Clinical programs and initiatives.
• Analysis of key performance indicators for Management Review in support of Clinical development programs.
• Supporting GCP inspection and audit activities and related preparedness tasks.
• Supporting or leading the development of global SOPs.
• Providing tracking and closure for global corrections/corrective actions related to inspection/audit findings.
• Providing tracking and closure for Clinical SOP deviation corrections/corrective actions.
• Serving as subject matter expert (SME) for Clinical compliance related questions and issues.
• Supporting and participating in a broad range of process improvement initiatives as directed.
MAJOR RESPONSIBILITIES:
Responsible for implementing and maintaining the effectiveness of the quality system.
• Participate in development and management of the compliance assessment schedule/plan.
• Prepare and conduct Clinical compliance assessments and report findings to stakeholders including recommendations.
• Manage the tracking and drive closure of related corrections/corrective actions along with providing trending analyses and metrics as needed.
• Provide trending analysis for SOP deviations and QA audits.
• Provide SME consultation on Clinical research related questions, related to compliance and SOP issues.
• Assure that during process and procedure development that appropriate solutions are incorporated to resolve/minimize compliance challenges.
• Assist in internal and external inspection support.
• Escalate significant issues to management and identify performance gaps relative to current regulations, improved efficiency and adoption of best practices and recommend corrective actions.
• Provide interpretation and gap analysis for relevant regulations and guidelines guidances.
• Develop work instructions/SOPs/tools to build consistency and compliance into processes throughout QCC.
ACCOUNTABILITY / SCOPE:
This position is responsible for the planning, performance, and results analysis of clinical research compliance assessments to ensure global clinical research is conducted per standard operating procedures and with applicable regulatory requirements and guidelines.
The impact on the organization of non-compliance typically results in significant effort (resources and time) to implement corrections and re-work. This could include a potential delay in clinical program delivery or regulatory submission/approval, loss of clinical data or a regulatory action which could lead to millions of dollars in direct cost of opportunity cost for Abbott Laboratories.
The individual in this position is expected to take independent initiative to solve problems, develop recommendations for process improvements, analyze questions and issues per internal and external requirements, and prioritize own daily activities.
This position reports to the Sr Manager, Clinical Compliance and is expected to meet with their manager on a regular basis for information exchange and problem resolution as needed.
The individual in this position is expected to work and communicate with all levels of the Development Operations organization and other GPRD functional areas as needed for compliance assessments and other job responsibilities.
PROBLEM SOLVING:
• Identify potential and communicate known compliance gaps at local and global levels.
• Take initiative and identify new approaches to resolve problems and mitigate risk.
• Successfully interact with all levels of personnel within Clinical Development and QA.
• Create compliance strategies to ensure continued quality clinical trial execution in accordance with standard operating procedures and applicable regulations and guidelines governing clinical research.
• Fairly high level of decision making involved in terms of evaluating findings from assessments in terms of internal and external compliance requirements.
• Evaluation and analysis of clinical research related questions and issues is an integral part of this position.
REQUIREMENTS - QUALIFICATIONS: MANAGER, CLINICAL COMPLIANCE
Will consider a job share arrangement for the right candidates.
Basic Qualifications:
• 6+ years professional relevant pharma experience: including a combination of clinical research, managing of clinical trials, managing of essential documents, GCP quality or compliance experience.
• Able to prioritize multiple tasks and/or projects with limited supervision.
• Hands-on experience with regulatory inspections and internal audits.
• Hands-on experience working with Abbott systems (e.g. IMPACT, Clinicopia, eRooms).
• Proven written and verbal communication skills.
• Excellent knowledge of ICH GCP, regulations and clinical research.
• Prior experience working from a global perspective desirable.
• Have skills to influence, negotiate and project manage.
• Able to work effectively with all levels of the organization.
• Able to separate critical from non-critical issues.
• Excellent problem solving skills and initiative.
Preferred Qualifications: Bachelor’s degree required, preferably in a scientific field.
Global Pharmaceutical R and D
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