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Clinical Study Team Assistant (CSTA) I

Employer
Pfizer
Location
Sandwich
Salary
Negotiable
Closing date
13 May 2021

Job Details

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.

The CSTA I:

  • 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.

ROLE:

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

Company

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. 

In the UK, we have around 2,400 colleagues across four locations, working within our commercial business, research and development (R&D), manufacturing and distribution operations.

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