The Clinical Operations Director is accountable for the day-to-day oversight of all clinical, scientific, technical and operational aspects of the clinical trials run at the NH PCRU. This includes feasibility, study placement and scheduling, volunteer and patient recruiting, project management, clin-ops staffing and resource management, quality activities and data management. The Clinical Operation Director leads the project management team, the call center team and the clinical research recruitment team. The Clinical Operations Director participates in strategic planning with the NH PCRU leadership, leads strategic planning for the NH PCRU teams within his/her group and leverages technical/functional expertise internally and externally. The Clinical Operations director is innovative, willing to take risks, and interprets the division’s strategy to establish business priorities that support and help to set long term direction and strategy for the NH PCRU.
Holds managers accountable for management skills and development of a diverse talent pipeline
Motivates direct and indirect reports and deliver results for the NH PCRU
In collaboration with other unit directors, develops and maintains unit capability (staff, facilities, equipment) to conduct a broad range of exploratory development studies.
Assures compliance of all activities with applicable regulations and guidelines
Assures adherence to NH PCRU and other relevant policies metrics and goals.
Works with colleagues in other Pfizer clinical research units to develop guidelines/policies for process standardization and cross site load sharing.
Identifies existing process improvements
Develops innovative, advanced new concepts that improve processes across own and related disciplines
Prioritizes and coordinates all efforts within the NH PCRU and collaborates between disciplines/divisions (Research Units,
Business Units, BRDU/BCD/Dx and other Pfizer Clinical Research Units) to resolve issues and accomplish organizational goals.
In conjunction with the Medical Director and other platform Heads, establishes policies and operational practices and assure exemplary medical and ethical standards.
Participates in the creation and implementation of global and local SOPs, ensuring staff are trained
Serves as an active member of the PCRU Leadership Team and the extended Global PCRU Leadership Team
Delegates to expedite operational efficiency and facilitate development of supervisory staff.
Coordinates, in collaboration with Business Technology, the implementation of emerging technologies to enhance the PCRU’s efficiency, productivity, and competitiveness.
Permanent on-call role for safety issues and decision-making for all aspects of PCRU-NH running.
On-site recall duty 24/7 in case of need or urgency.
Collaborates with the System Users Group for any future EDCMS version specifications and improvements and Global CRU IT
Systems enhancements and implementations as necessary.
Participates in training courses as appropriate and ongoing continuing education
Responsible for complying with Pfizer Standards, ethical standards, ICH, regulatory and legal requirements, national laws on health and safety at work, fire prevention and other appropriate legislation
Qualifications
BA degree and 15 years experience required
Masters or doctoral degree in biomedical sciences preferred
Previous direct work experience (10+ years) in a clinical research unit preferred
IT Knowledge: Excellent working knowledge of computers, including Microsoft Office, electronic data capture monitoring systems (EDCMS), and database management
Scientific / Clinical / Research Knowledge
Excellent knowledge of medical conditions, nursing and research techniques, and application of clinical research
Ability to review and understand emerging safety and efficacy profiling of a drug candidates and recognize potential serious adverse effects.
Demonstrated understanding of the complexities and recent developments in exploratory research. Understanding of clinical pharmacology issues
Exposure to exploratory development strategies and full development activities
Demonstrates comprehensive industry knowledge.
Business expertise and an understanding of the external marketplace and customer requirements of pharmaceutical research and development operations
Clear understanding of the dynamic nature of pharmaceutical research and development operations
Ability to align clinical skill sets with protocol requirements to assure appropriate staffing for studies
Language Skills
Good written and verbal skills in English are essential.
Knowledge of Spanish a plus.
Finance Awareness
Ability to develop budget estimates, justify costs and manage performance against budget
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