Global Head - Study Monitoring - Roche - Indianapolis

Job description
The Global Head Study Monitoring directs and oversees clinical study monitoring globally at Roche Professional Diagnostics (RPD), linking clinical trial portfolio strategy and deliverables to business objectives. May serve as principal or advisor providing consulting in the areas of design validation, pre-clinical and clinical research methods. Ensures that execution of RPD studies are done in accordance with Clinical Development Plan, Design Validation Plan, subsequent study protocols and that these meet industry and regulatory standards as well as client requirements and expectations.
Responsibilities include:
• Ensures the necessary study monitoring resources and adequate medical / diagnostic / technical competence in RPD ClinOps are in place globally. Oversight, management and development of internal and external study monitoring resources. Leadership of Site Heads for Study Monitoring.
• Ensures that clinical studies are globally managed in a competent and regulatory compliant way according to goals and set priorities and within the planned time and cost parameters.

• Ensures that clinical studies, as relevant for global monitoring operations are planned, initiated and coordinated in agreement with the Study Management group and Life Cycle Teams (LCT’s). Responsible for planning and coordination of content and budget for the LCTs for studies run by global monitoring or 3rd party vendors.
• Accountable for development and implementation of flexible resourcing within global monitoring.
• Ensures in-depth understanding of RPD monitoring processes and tools within global monitoring group
• Coordinates tasks in Clinical Operations Study Monitoring, such as professional coaching, drawing up and overseeing achievement of goals and organizational development.
• Ensures clinical study quality at external sites and within global monitoring group. Ensures up to date knowledge of GCP and regulatory requirements as it comes to monitoring activities and sponsor’s obligations.
• Serves as administrative Site Leader for the entire Indianapolis Medical and Scientific Affairs team.
• Accountable for local cross functional leadership and staff meetings
• Accountable for local cross functional decisions at the site
• Accountable for resolving cross functional personnel conflicts
• Accountable for site facility management and site occupational safety topics
• Acts as an initial point of contact for audits at site
• Site representation for internal and external stakeholders

Provides strategic decision making, leadership and planning including the efficient and effective use of study monitoring resources. Achieves results through the leadership of managerial, professional and/or support staff. Delegates responsibilities to global study monitoring staff. Sets policy and strategy for own department. Has full HR responsibility for direct and indirect reports. Has full budget responsibility for assigned functional area or departments.

Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.

Desired Skills and Experience
Minimum qualifications include:
• Masters degree in Medical Technology, Nursing, Pharmacology, Biology, Biochemistry or related field.
• 10+ years study monitoring experience including at least 8 years of direct hands-on management experience with a proven track record of success for leading in an international environment.
• Knowledge of applicable standards and regulations for clinical trial and laboratory conduct (Roche, CFR, ICH, Federal guidelines, GMP, GLP, ISO, safety, etc.)
• Ability to travel internationally 30%+

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