Ref #: 27942

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 18-May-2021

Description

Ensure regional/global clinical operations deliverables progress according to agreed upon timelines and milestones as leader of the Study Management Team. This includes country & site feasibility and site selection, trial set-up, study execution and trial closure and vendor setup activities as assigned by the Global Trial Leader.
Set-up country budgets and monitor actuals vs forecast for Out of Pocket Expenses, and review assigned vendor invoices/spend.
Establish enrolment commitments and ensure actual enrolment meets projected commitment across the regions at the clinical trial level.
Create and update study-specific documents such as Monitoring Guidelines, Informed Consent Form, IMP related documentation, Blinding Plan, country and site feasibility related documents.
Provide input into cross-functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan.
Create appropriate trial-specific training materials and requirements, making them available to the site study staff and delivering training as needed. Responsible for the set-up and coordination of Investigator Meetings, if applicable, in close collaboration staff as well as Global Trial Leader.
Act as the primary contact person for the local teams within the team.
Establish and maintain excellent working relationships with internal stakeholders, including Local Trial Managers.
Demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge.
Ensure compliance with global health authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of ,Health
Authority inspections and internal QA audits. Ensure that the Study Management Team operates in a constant state of inspection-readiness. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
Provides updates to all Study management Team as well as Trial Team members on the deliverable status. Ensure required reports are generated and available for realtime tracking of trial status. Manage timely and accurate documentation, communication of study progress and issue escalation

Qualification and experience required:

1-3 years strong clinical trial management experience in the pharmaceutical industry or CRO, however, other relevant experiences and skills maybe considered by the hiring manager when considering the candidate’s eligibility.
Requires clinical research operational knowledge, strong project planning/management and effective communication skills
Should be flexible and have experience and ability in managing global or regional teams in a virtual environment. Proven record of accomplishment in successfully managing trials from start- up to database lock. Experience with supervision of CROs/vendors is preferred.
Specific therapeutic area experience maybe required depending on the position.
Strong decision-making and communication/collaboration skills are essential to this position, as are analytic skills and effectiveness in seeking solutions to issues.
Effective leadership skills and proven ability to foster team productivity and cohesiveness. Computer literacy is also required.
Willing to travel up to 20% of time.
Please note that this position can be based in EMEA such as UK, Spain, Germany, Belgium, France or Poland. You will need to have permanent right to work in the those countries already, as we do not provide sponsorship.

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