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.

• Management and oversight of Study Team shared spaces.

• Trial Master File (TMF) maintenance, compliance, and oversight.

• Analyze, interpret, and follow up on metrics.

• Management and oversight of Study Team on Demand (STOD).

• Analyze, interpret, and follow up on metrics.

• 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.

• 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.

• 0-3 years of experience with BA/BS or 0-1 years of experience with MA/MBA/MS.

• Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS).

• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research.

• Science background.

• Experienced with clinical trial processes and applicable systems.

• Effective verbal and written communication skills.

• Ability to work independently but also as part of a larger team with limited support from supervisor.

• Ability to multitask and manage multiple competing priorities.

• Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality.

• Knowledge of drug development process.

• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.

• Good problem solving & decision-making skills: Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problems.

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