Role Summary:
The Clinical Study Team Associate (CSTA I) is an essential part of the Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and Pfizer SOPs. The role collaborates with global study team members and is responsible for multiple tasks that span from study start-up to study close-out which enables the efficient execution of clinical trials to high-quality standards.
The Clinical Study Team Associate (CSTA I):
- Partners with the Clinical Study Team Lead (CSTL) in providing study level operational leadership and support to clinical study teams.
- Partners with the Global Study Manager and the Study Manager in providing site management, monitoring and vendor operational oversight and support.
- Works proactively with minimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes.
- Collaborates with global cross functional study team members of varying levels of seniority.
- Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards.
- Requires fundamental knowledge of the principles of the role and applies these skills to achieve assigned tasks
Role Responsibilities
The Clinical Study Team Associate (CSTA I) is responsible for providing study level operational support to the Study Team from study start up to close out and submission including:
- Management and oversight of Study Team shared spaces
- Trial Master File (TMF) maintenance, compliance, and oversight
- Management and oversight of Study Team on Demand (STOD)
- Maintain Pfizer registries and systems as required to ensure compliance
- Tracking and oversight of study information; follow up with functional lines as needed
- Liaising with cross functional study team members to initiate and coordinate the completion of study level forms and data entry into various clinical operations applications and systems, provide study level reporting to support management of clinical trial data, clinical trial budget and timelines
- Quality control of essential clinical trial documentation including components of the Clinical Study Report (CSR) and regulatory submission
- Support engagement of Independent Oversight Committees
- Provide support with audit and inspection readiness activities
- Assist with oversight and tracking of Clinical Trial Budget spend
- Provide logistical and operational support for Investigator Meetings
- Coordinate the translation of documents as required
- Provide status updates on key tasks and contribute to the Study Team Meetings as an active Study Team member
- Provide support to study teams with system setup and maintenance
- May provide support for global study team communications to sites
Here Is What You Need (Minimum Requirements):
- BA/BS with any years of experience
- Demonstrated ability to introduce new ideas and knowledge on all relevant Standard Operating Procedures
- Ability to prioritize multiple tasks and develop strategies for the completion of all required activities
- Strong organizational skills and attention to detail
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
- Excellent written and verbal communication skills
Bonus Points If You Have (Preferred Requirements):
- Experience in the management of clinical trial and regulatory documents
- Solid understanding of International Conference on Harmonization Good Clinical Practices and local regulations
- Familiarity with applications used in clinical trials
- Experience with electronic data capture systems
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: Hybrid
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.
Medical