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ROLE SUMMARY
The Clinical Trial Assistant (CTA) is an essential part of the Local Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, GCP, Pfizer SOPs and country regulations. The role collaborates with local 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.
ROLE RESPONSIBILITIES
The CTA:
Works independently to carry out key tasks using established procedures and methodologies to ensure the completion according to timelines and to required quality standards.
With general direction, the CTA is responsible for providing technical and operational support to Local Study Team members from study start up to close out:
CTAs may specialize in one or more routine tasks, and be expected to provide support across the whole role as needed. Key tasks supported by the CTA group are
TMF filing, quality, maintenance, compliance, and oversight
Development and delivery of sites’ ISF, and eISF when utilized, and act as primary point of contact for the sites and manage the Site Operations/monitor access to eISF prior to SIV
Maintain Pfizer Registries and systems as required
Provide reporting to support management of clinical trials
Provide support with audit and inspection readiness activities
Perform customization and translation of documents as required
Manage Physical Archiving needs as required
Preparation of documents and communications for distribution to and collection from sites, as required
At Associate level the CTA may contribute to team projects and initiatives at the country or regional level.
BASIC QUALIFICATIONS
PREFERRED QUALIFICATIONS
LI#PFE
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.
Medical
Paid paternity
Paid maternity
Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place. Every day, our colleagues work in developed and emerging markets to ...