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The CSTA Manager strives to create a strong culture of customer service for CSTA resourcing and the CSTA Group. The CSTA Manager is responsible for ensuring that appropriate CSTA resources are in place to support the clinical trial portfolio of studies. The CSTA Manager creates, maintains, and assumes accountability for a strong culture of customer service using various tools to facilitate communication, operational transparency, resourcing, and alignment within and across functional lines. The CSTA Manager oversees resourcing and multiple projects/work activities for direct reports as well as the broader CSTA group.
The CSTA Manager provides managerial oversight of CSTA colleagues and their deliverables and is responsible for performance management and talent development of CSTAs. The CSTA Manager is a leader within the CSTA Group and is responsible for providing leadership, guidance, and support to both direct and the broader CSTA group. The CSTA Manager has strong technical/functional knowledge of the CSTA role to coach direct reports on day-to-day activities. The CSTA Manager is responsible for ensuring that their direct reports are adequately trained on Pfizer systems and processes and that they are providing quality support to their assigned study teams, programs, and projects. If assigned, the CSTA Manager will have oversight of CSTA FSP resources as well.
The CSTA Manager is a subject matter expert (SME) on CSTA systems and processes, has strong knowledge of related clinical operations disciplines, and is responsible for identifying potential process improvements and taking appropriate risks to develop innovative solutions to improve the CSTA Group’s work processes. The CSTA Manager contributes to CSTA Group strategies and supports the CSTA Leadership in solving moderately complex issues related to the CSTA Group and related disciplines.
The CSTA Manager collaborates with key partner lines to ensure alignment and consistent delivery in the CSTA role and is responsible for ensuring that there are consistent and harmonized processes in place for the CSTAs.
In addition to the management of CSTAs, the CSTA Manager may be required to perform the role of a CSTA
- Is accountable to the CSTA Global Lead.
- Direct line management of CSTAs; Oversight of FSP CSTA resources.
- Responsible for ensuring that the clinical trial portfolio is adequately resourced with CSTA support; manage resourcing requests and ensure that CSTA assignments are accurate in the resourcing team space.
- Recommend and implement strategic resourcing plans for CSTAs; identify potential resource risk and proactively seek solutions.
- Recognize, initiate, and manage change that may impact the Department.
- Ensure that direct reports are appropriately trained on Pfizer SOPs and systems; mentor and train new CSTAs.
- Provide development and training opportunities for direct reports; manage the performance of direct reports through goal setting, ongoing assessment, and coaching; encourage active participation from direct reports.
- Provide support to CSTAs to ensure successful execution of CSTA tasks on assigned studies, and on special project and submissions assignments.
- Actively share knowledge with direct reports and ensure that processes are consistent and harmonized.
- Act as subject matter expert (SME) on CSTA processes and collaborate to facilitate the sharing of functional expertise and best practices across the CSTA Group.
- Identify continuous improvement opportunities to enhance operational efficiencies through process and metrics analysis.
- Coach direct reports to ensure they have the technical knowledge and experience to work with all members of the cross functional study team.
- Ensure efficiency, timeliness, and quality of deliverables for direct reports and the CSTA Group.
- Ensure CSTAs work in alignment with company core values, Standard Operating Processes (SOPs), and policies.
- Manage the performance of direct reports through goal setting, ongoing assessment, and coaching; guide direct reports on relevant experiences to meet career objectives; assess and manage performance issues of direct reports.
- Disseminate or present key information to direct reports and CSTA group as necessary/required.
- Contributes to the CSTA group strategies by collaborating within the CSTA Group as well as with cross functional partners.
- Contribute to the development and delivery of presentations within the Department.
- Apply technical knowledge to recognize problems or delays; proactively identify and anticipate issues; act to prevent or address issues.
- Identify potential advanced CSTA tasks as well as study expansion possibilities.
- Identify improvements to existing CSTA processes and contribute to the development and implementation of new and/or revised CSTA processes, standards, and systems.
- Participate in the development of strategies and goals for the CSTA Group; continuously evaluate and evolve the CSTA role to add value and efficiencies to the cross functional study team.
- Solicit input and explain difficult concepts and persuade others to adopt a point of view; effectively share own point of view and rationale.
- May also be required to fulfill the role of the CSTA in addition to oversight and managerial responsibilities.
- 5+ years exp with BA/BS or 3+ years exp with MA/MBA/MS or 10+ years exp with Associate’s degree
- Excellent oral, written, and interpersonal skills
- Relevant industry experience and thorough understanding of the processes associated with clinical trial operations
- Excellent planning, observation, analytical and problem-solving skills
- Detail oriented
- Excellent systems and application technical skills
- Ability to work independently with minimal guidance from manager for work plan, task allocation and FTE utilization
- A strong knowledge of working across global cross functional teams
- Excellent problem-solving skills.
- Resourcing experience preferred
- Ability to work well and lead direct reports in a virtual environment and in matrix and multi-cultural organization
- Solid knowledge of ICH GCP and applicable regulations
- Strong industry knowledge and comprehensive understanding of business processes.
- Experience in management of clinical trial and/or regulatory documents
- Strong knowledge of applications used in clinical trials
- Solid understanding of CSTA job tasks and responsibilities
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