SUMMARY

The Clinical Study Team Assistant I (CSTA I) is an essential part of the Core Study Team and is accountable for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, GCP, and Pfizer SOPs. The role partners 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.

• Partners with the Clinical Study Team Lead (CSTL) in providing study level operational leadership and support to clinical study teams.
• Works proactively with minimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes.
• Partners 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.
• Has fundamental knowledge of the principles and concepts related to the CSTA role.

RESPONSIBILITIES:

With general direction, the CSTA I is accountable for providing study level operational support to the Core Study Team from study start up to close out and submission:

• Management and oversight of Study Team shared spaces
• 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
• Corporate Clinical Trial Registry (CCTR) compliance and maintenance
• 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 help management of clinical trial data, clinical trial budget and timelines
• QC of essential clinical trial, CSR and regulatory submission documentation
• Manage engagement of Independent Oversight Committees
• Provide support to the CSTL and Clinical Quality Lead with Inspection Readiness Activities
• Assist the CSTL with oversight and tracking of Clinical Trial Budget spend
• Provide logistical/operational support to Study Management for Investigator Meetings
• Provide status updates on key tasks and activities to the CSTL and contributes to the Core Study Team Meetings as an active Core Study Team member.
• On occasion, work on short term Clinical Operations Special Project requests (eg workstreams, initiatives, projects).
• With general direction, manage conflicting priorities to ensure excellent support to assigned study teams. Manages own time to meet established targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables).
• Partners with cross functional study team members to ensure completion of assigned tasks.
• Occasional travel for group meetings (approximately 1-2 times per year).
• Flexibility to work off-hours in a global environment (when needed)

BASIC QUALIFICATIONS

• Moderate level of experience with BA/BS or 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

PREFERRED QUALIFICATIONS

• Science background
• Experienced with clinical trial applications.
• 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: 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.

• The successful candidate will be expected to work from the Pfizer Sandwich, Kent office 2/3days per week.

Work Location Assignment: On Premise

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 Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!