ROLE SUMMARY

The Clinical Study Team Associate II (CSTA II) is an essential part of the Study Team and is responsible for driving and/or 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 CSTA II:

• 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 and independently 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.

• Ensures the completion of assigned tasks according to timelines and to required quality standards.

• Requires strong understanding of the principles of the role and applies these skills and study operational knowledge to achieve assigned work.

ROLE RESPONSIBILITIES

The CSTA II is responsible for providing study level operational support to the Study Team from study start up to close out and submission:

• 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 (analyze, interpret, and follow up on metrics)

• Maintain Pfizer registries and systems as required to ensure compliance.

• Tracking and oversight of study level 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 activities 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

Provide support to CSTA managers for development and implementation of on-boarding training for new hires:

• Provide training to new hires

• Mentor new hires and entry level CSTAs

Serve as Subject Matter Expert for key CSTA processes, systems and tasks. Work with CSTA managers to identify continuous improvement opportunities to enhance operational efficiencies.

Qualifications

BASIC QUALIFICATIONS

• 3+ years exp with BA/BS or 1+ years exp with MA/MBA/MS
• Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)
• Relevant clinical research or clinical trial experience

PREFERRED QUALIFICATIONS

• 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
• 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
• Strong knowledge of drug development SOPs, ICH/GCP requirements, clinical trials, medical terminology
• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
• Good problem solving & decision-making skills: Ability to work in ambiguous situations within the team to identify and resolve complex problems; 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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