Ref #: 32011

Employment type: Permanent - Full-Time

Location: United Kingdom

Posted: 12-Oct-2021

Description

Job 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:

2-3 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.

• Maintains liaisons with clinical research organizations or internal clinical trials administration and operations department to initiate and expedite clinical studies on products that have investigational new drug or medical device approvals

• Monitors reporting systems to look for trends and/or issues in the data/study conduct metrics.
• Analyzes/summarizes the data for reporting
• Supports compliance with global health authority regulations and guidelines an internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the SMT operate in a constant state of inspection readiness.
• Work With Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools

• Support staff, as appropriate, in the set-up and coordination of Investigator Meetings, if applicable. Presentation of training materials at internal/external training opportunities

• Supports team by monitoring budgets and expenditures as required by trial budget and expectations.

• Support availability of required reports to manage/ensure real time tracking of trial status according to Trial Plan

Profile:

• University/Bachelors Degree or Equivalent
• Minimum of 3 years clinical trial execution experience in the pharmaceutical industry
• Requires clinical research operational knowledge, project planning/management and communication skills.
• Good working knowledge of ICH, GCP and FDA guidelines/regulations
• Solid understanding for the drug development process with a special emphasis on clinical development
• Ability to multi-task
• Excellent computer skills

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