Clinical Trial Associate II (12-month secondment)

ROLE SUMMARY

The Clinical Trial Associate II (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.

The CTA II:

• Works proactively and independently to coordinate and prioritize multiple key tasks at site country and study level.

• Contributes to best practices within the team to ensure efficient task support with a high quality output.

• Collaborates with local cross functional study team members of varying levels of seniority.

• Gathers and retains knowledge of local processes that enable clinical trial execution where .

• 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 CTA role.

• Can contribute to the evolution of specialist work within the team.

ROLE RESPONSIBILITIES

With little direction the CTA II is responsible for providing technical and operational support to Local Study Team members from study start up to close out and can be part of the local country operational team. 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

• Lead the 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

• Provide & analyze reporting to support management of clinical trials

• Provide support with audit and inspection readiness activities

• Perform customization of site documents

• Coordinate the translation of documents as

• Manage Physical Archiving needs as

• Preparation of documents and communications for distribution to and collection from sites as

• Support site invoicing activities

• Demonstrate leader behaviour with ensuring high quality standard for the team

• Provide support to CTA managers/designee for development and implementation of on-boarding training for new hires:

• Mentor new hires and entry level CTAs

• Serve as SME for key CTA processes systems and tasks.

• Work with CTA managers to identify continuous improvement opportunities to enhance operational efficiencies.

CTA IIs could:

• Create edit & manage tasks to support strategic centralized site & country support.

• Track the claiming & completion of tasks to ensure efficient delegation and shorter portfolio timelines.

• Internally support and be an advocate of issue resolution at the lowest level.

• Supports managers with resourcing assignments within the team.

BASIC QUALIFICATIONS

• Bachelors degree is required.

• 3years relevantexperience/strongunderstandingofthescopeofclinicaltrial administration.

• Experienceinmanagingworkloadindependentlyandmanage prioritieseffectively.

• Experienceinoneormoreofthefollowing:crossborderlogisticsregistrysystemdata management;TMF compliance; study team support role.

• Fluent English Language skills plus competence in one other language.

Please apply by sending your CV in English.

Work Location Assignment:Hybrid