Pfizer's belief is that all people deserve to live healthy lives. This drives our desire to provide access to medicines that are safe, effective, and affordable. We advance breakthroughs that change patients' lives and increasingly there is a digital component to the interactions we have with patients and their health care professionals.
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 orientation, age, gender identity or gender expression, national origin, disability.
- 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.
- 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 CSTAs work in alignment with company core values, Standard Operating Processes (SOPs), and policies.
- 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.
- 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