Pfizer Clinical Operations Director in New Haven, Connecticut
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 Pfizer Clinical Research Unit-New Haven (PCRU-NH) . This includes feasibility, study placement and scheduling, volunteer and patient recruiting, project management, clinical operations 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 PCRU-NH leadership, leads strategic planning for the PCRU-NH 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 PCRU-NH.
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Oversees project management function ensuring cross functional project management leadership for PCRU-NH study teams regarding input into protocol development; study feasibility and execution; study delivery according to agreed quality, timeline and cost parameters; study data integrity and data quality, and; study compliance with GCP, relevant SOPs and local regulatory requirements
Oversees the recruitment function including volunteer and patient recruitment deliverables (eg, activities related to volunteer database management, preselection of suitable study candidates and overall interaction with clinical trial volunteers); development and management of volunteer recruitment capabilities to conduct a broad range of exploratory development studies; long term recruitment planning (eg, anticipation and preparation for all exploratory and full development studies conducted in PCRU-NH); and; building/ enhancing capabilities in recruitment and volunteer outreach (eg, social media and identifying and leveraging new channels for advertisement).
Holds managers accountable for management skills and development of a diverse talent pipeline
Motivates direct and indirect reports and deliver results for the PCRU-NH
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 PCRU-NH 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 PCRU-NH 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 managementScientific / 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
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.