Ref #: 28184

Employment type: Permanent - Full-Time

Location: Poland

Posted: 02-Apr-2021

Description

Global - Clinical Trial Assistant
TO APPLY
Please contact Dagmara Drozdowska, Recruitment Consultant at DOCS on +48 668 87 02 61 or email your up-to-date CV to: dagmara.drozdowska@docsglobal.com

POSITION SUMMARY
This position will support the operational aspects of all globally managed trials, both internally managed and outsourced trials, with variation across all phases of a trial (planning, start -up, execution, data analysis, reporting and disclosure). You will work in support of the Clinical Trial Manager (CTM) to track study timelines and trial budget, to support protocol and country feasibility, site selection, and trial and vendor set -up, study execution and trial closure related activities.
Responsibilities include but are not limited to generation of progress tracking reports, analysis and follow-up, trial specific system set-up and access management, system data entry, setting up meetings and maintaining minutes, document management and investigator meeting set-up and coordination.
This position will report into a DOCS Operations Manager or DOCS Functional Manager with dotted line matrix reporting structure with designated trial team members.

JOB FUNCTIONS/ RESPONSIBILITIES
• Assist in study specific document management, including finalization, distribution, and document revision management and archiving.
• Assist in ancillary supply management, including ordering, distribution, and tracking.
• Ensure the current study status and tracking of trial related information is available at all times in the appropriate clinical trial management system(s) (CTMS).
• Work with CRO, Local Trial Managers and CRAs to ensure trial specific data are up-to date, complete, and accurate during all phases of the trial.
• Support study coordination activities and tracking of study timelines and study deliverables to ensure trial delivery according to agreed upon timelines/milestones.
• Responsible for review/management of Trial Master File (TMF) for completeness and timely provision of TMF content across all GCO functions.
• Support running GCO dashboards & metrics reports with option to provide status
analysis.
• Coordinate and participate in internal and external study specific meetings, as
necessary, and document outcomes, actions, and decisions.
• Support medication related activities e.g. shipment tracking for non IWRS trials,
• Coordination of relabelling, recall, product quality compliant, and follow-up.
• Maintain key trial specific information including contact lists and set-up of study
specific training curriculum, and follow up on training completion.
• Support quality oversight and inspection readiness activities.
• Work with internal partners to assist in management of activities such as country and
site feasibility, and obtaining country-specific clinical trial insurance.
• Work with internal partners, and external vendors including Contract Research
• Organization/Academic Research Organization for outsourced trials/activities.
• Assist CTMs with applicable system support, (i.e., ARIBA, Totality), tracking of vendor work orders and change orders, tracking and analysing the trial budget, including actual vs. plan trial budget spend, follow-up on variances as needed.
• Provide overview of data management metrics as needed, including status of data
entry/missing pages, source data verification progress, and query resolution.
• Other activities as delegated by the CTM or PM

EXPERIENCE/ REQUIREMENTS
• At least Bachelor’s degree preferred
• At least 2-3 years relevant work experience as CTA
• Excellent organization skills
• Excellent written and verbal communication skills.
• Excellent independent time management skills.
• Proven ability to plan and track deliverables and timelines.
• Ability to work well in a dynamic environment and able to prioritize and respond to
• changing needs of the business.
• Proficient Microsoft Office applications and use of Internet, EXCEL, POWERPOINT, WORD.