Pfizer Sr. Supervisor, Data Management Team Lead in Wuhan R&D Center, China
• Manage the team of Data Managers at Wuhan
• Ensure relevant SOPs and processes are consistently implemented
• Monitor and report on the progress of achieving functional area goals
• Develop colleagues in the team, including recruitment, retention, mentoring and performance management for staff.
• Ensure that all data management activities are conducted in compliance with applicable Pfizer SOPs and processes, Pfizer Data Standards, as well as relevant regulatory requirements.
• Partner with CDS peers to implement strategies to ensure on time delivery and high quality in data acquisition, and data management, query resolution, data access and report generation from study set-up to database release.
• Manage the DM team to meet/exceed CDS metrics and study specific goals.
• Work with peers to resolve cross-functional barriers that prevent achieving data management milestones.
• Ensure appropriate resources are identified and allocated to support assigned studies and tasks.
• Actively participate in project review meetings.
• Develop and maintain charters, resource utilization metrics and project plans.
• Partner with peers to promote initiatives in improving work efficiency.
• Customer Support experience: Demonstrated knowledge and success in supporting external and/or internal customers in a clinical development environment.
• Site/Team Management experience: Previous people management experience is strongly preferred.
• Process improvement/tracking: Demonstrated capability in developing tracking tools to manage and evaluate workflow and workload. Ability to evaluate data and change processes as necessary for efficient use of personnel and resources.
• Project/process management: Experienced in managing complex projects and processes
• Clinical &; regulatory processes: Demonstrated knowledge in clinical development, ICH/GCP and regulatory requirements
• Scientific/administrative excellence: Demonstrated success/results in prior scientific/administrative management roles
• Systems Technologies: Knowledge/understanding in technologies to support clinical data acquisition, data validation and data cleaning; strong understanding of the state-of-the-art clinical data management technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption
• Presentation/influencing skills: Demonstrated platform skills; experience presenting to large scientific audiences and non-science populations
• Budget / expense management: Understands and has demonstrated ability to manage budget; history of staying on or under budget
• Proven strong supervisory and leadership skills: Demonstrated ability to manage a team of clinical professionals. Transparent skills in providing vision, direction and leadership to a group of individuals with different levels of experiences.
• Minimum of a B.S. degree in either scientific or medicinal related field, e.g. clinical medicine, pharmacology, or other life science majors.
• Advanced degree is preferred.
• Demonstrated knowledge on drug development and clinical trial operations with thorough understanding and extensive experience in clinical data management.
• Comprehensive technical capability in applying clinical trial database and applications in implementing CRF design, clinical database set up, data review, query resolution, reporting, etc.
• Demonstrated success in managing multiple clinical programs and complex projects and timely delivering high quality results.
• Previous experience leading a substantial group responsible for clinical data management, clinical study management, or equivalent function in clinical operations.
• Demonstrated leadership behaviors and resource management (staff and financial) skills.
• Strong negotiation and conflict resolution skills are essential. Ability to remain focused in high-stress situation is very important.
• Proven history of success in building strong customer relationships.
• Effective verbal and written communication in English. An international experience is a plus.General
Provide administrative and data management technical and process oversight of team.
Implement strategies to ensure consistent processes in strong collaboration within CDMM and with CO, CPW, CDQ, DMM and Alliance Partners
Participate in Dev Ops initiatives with CO, CPW, CDQ, DMM and Alliance Partners.
Develop charters, resource utilization and project plans to achieve CDMM specific goals.
Implement organizational design and develop succession planning for group.
Develop colleagues, including recruitment, retention, and career development and performance management for staff.
Ensures Conformance to Pfizer Data Standards.
Actively participates in monthly project review meetings.
May participate in Therapeutic Area (TA) specific process improvement initiatives.
Manage the DM team to CDMM metrics goals and work with CROSLs to resolve cross-functional barriers to achieving data management milestones.
Actively oversees EPM project milestones and networks inconsistencies with relevant Asset Leaders and/or relevant project lead of APs
Ensure appropriate resources are identified to support the portfolio.
Ensure that all data activities are conducted in compliance with relevant regulatory requirements.
Monitors and reports on implementation of functional area initiatives
Is accountable for the implementation of team CDMM data activities including Study Startup, Data Acquisition, Safety Data Management, Dictionaries, Standards and Discrepancy Management for site-based or global studies related to the drug programs.
Partner with other CDMM TA Lead, TechOps Lead, CO, and APs to promote the increased efficient use of EDC methods and technologies in clinical trials.
Partner with other CDMM Team Leaders, CO, and APs to implement strategies to ensure speed and quality of data acquisition and data management, query resolution, data access and database release.
N: Not Applicable - 不适用 (China)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.