Labcorp Unblinded Service Specialist - sponsor dedicated, EMEA in Russia
Labcorp Drug Development is actively searching for an Unblinded Service Specialist to be client-dedicated with a global Pharmaceutical company.
Previous CRA experience is essential with lead experience, or PM knowledge and experience an advantage. The successful canddiate will be responsible for oversight of Unblinded CRA team project deliverables, metrics, report review, reporting to client & Country POC with client for unblinded model.
Accountable for the execution and oversight for the delivery of all services within an FSP
model, in line with the current Clinical Service Agreement (CSA).
Responsible to ensure high quality performance for optimal service delivery.
Responsible for providing instructions and direction on all tasks and activities related to the Labcorp unblinded CRAs (uCRAs) roles.
Primary point of contact (POC) for Covance uCRAs in case of issues with tasks assigned.
Primary POC for client Managers regarding unblinded monitoring services.
Works collaboratively with client managers for forecasting, planning and execution of all
services, as per CSA.
Essential Job Duties:
Identification of projected unblinded units, appointment and onboarding of any
new resources in line with ongoing demand.
Assign and allocate required resources (uCRAs) to tasks / protocols to fulfil unit services
outlined in the CSA.
Responsible for the development and delivery of Training Materials for uCRAs and
to ensure compliance with the relevant training plans.
Responsible for service delivery oversight and management of the operational study management teams per study for the unblinded monitoring.
Reviewer / Approver of unblinded monitoring visit reports in accordance with monitoring plans, ICH GCP and good documentation practice.
Manages the successful design, implementation, tracking and revision of the project plans to achieve project objectives (patient recruitment / safety, site compliance, study milestones).
Set up and maintain the communication plan with the client.
Conduct quarterly cluster review meetings with the dedicated client manager team to monitor, track and report progress against client project metrics related to clinical operations deliverables and agreed KPIs as per CSA.
Solution orientated support of client management team in case of project issues.
Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects / tasks.
Ensure smooth project handover and collaboration with the client to fulfil the agreed services per CSA on the assigned projects.
Regular interaction with client to discuss projected unblinded units and quality of completed unblinded units and any action to be implemented to reach client expectations of the unblinded monitoring.
Follow up of the KPIs agreed between Labcorp & Client.
University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
In lieu of the above requirement, candidates with six (6) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
Detailed knowledge of financial control procedures (i.e. costing systems, time reporting).
Working knowledge of project management processes.
Working knowledge of time and cost estimate development
Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries. Thorough understanding of the drug development process.
Minimum of five (5) years relevant clinical research experience including demonstrated skills and competency in clinical project management tasks, especially regarding quality and metric management.
In lieu of the above requirements, candidates with > five (5) years supervisory experience in a heath care setting and five (5) years clinical research experience with at least one (l) year project management experience in the pharmaceutical or CRO industries will be considered.
Experience in managing projects in a virtual environment.
Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
Financial awareness and ability to actively utilize financial tracking systems.
Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
Excellent communication, planning and organizational skills.
Ability to review/analyze and report relevant data and interpret protocols and regulatory documents.
Ability to work independently.
Ability to negotiate and liaise with clients in a professional manner.
Ability to present to staff at all levels.
Strong computer skills with an ability to understand, access and leverage technology alternatives.
A working knowledge of ICH GCP, US FDA regulations, regulations applicable to local office, guidelines, and practices regarding Good Clinical Practices.