• Assist in the cross-unit coordination both internal and external, inclusive of sub-contractors, for projects utilizing one or more Covance Services or sites.
• Assist in the management and tracking of project resource needs and contribute to contingency planning for key resources.
• Assist in the successful design, implementation, tracking and revision of project plans for assigned projects.
• Serve as client primary contact for areas assigned by Project Managers (PM), Senior Project Manager (SPM), or Project Director (PD).
• Assist in the leadership of the core project team, including CRAs, as directed by PM/SPM/PD to facilitate their ability to lead extended/complete project team including the maintenance of timelines in MS Project, creation of PowerPoint presentations and storyboards and maintenance and escalation of items in ADI log.
• Contribute to the effective teamwork among project team members within Covance departments and offices.
• Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects.
• Meet/exceed client satisfaction expectations.
• Assist in ensuring that all staff allocated to assigned projects adheres to professional standards and SOPs.
• Provide performance feedback of team members to respective supervisors.
• Interpret billing guidelines for functional area.
• Follow defined project issue escalation process and Covance's Corrective Action Issue Resolution (CAIR) process.
• Under direction of PM/SPM/PD, identify and assess risks and maintain associated documentation.
• Under direction of PM/SPM/PD, track project progress against financial milestones using applicable financial systems.
• Develop and maintain relationships with assigned clients.
• Contribute and participate in the delivery of presentations for new business, as required.
• Track client project metrics.
• Participate in internal project review meetings.
• Perform other duties as assigned by management
• Assist in the management and tracking of project resource needs and contribute to contingency planning for key resources.
• Assist in the successful design, implementation, tracking and revision of project plans for assigned projects.
• Serve as client primary contact for areas assigned by Project Managers (PM), Senior Project Manager (SPM), or Project Director (PD).
• Assist in the leadership of the core project team, including CRAs, as directed by PM/SPM/PD to facilitate their ability to lead extended/complete project team including the maintenance of timelines in MS Project, creation of PowerPoint presentations and storyboards and maintenance and escalation of items in ADI log.
• Contribute to the effective teamwork among project team members within Covance departments and offices.
• Contribute to improvements to enhance the efficiency and the quality of the work performed on assigned projects.
• Meet/exceed client satisfaction expectations.
• Assist in ensuring that all staff allocated to assigned projects adheres to professional standards and SOPs.
• Provide performance feedback of team members to respective supervisors.
• Interpret billing guidelines for functional area.
• Follow defined project issue escalation process and Covance's Corrective Action Issue Resolution (CAIR) process.
• Under direction of PM/SPM/PD, identify and assess risks and maintain associated documentation.
• Under direction of PM/SPM/PD, track project progress against financial milestones using applicable financial systems.
• Develop and maintain relationships with assigned clients.
• Contribute and participate in the delivery of presentations for new business, as required.
• Track client project metrics.
• Participate in internal project review meetings.
• Perform other duties as assigned by management
Education/Qualifications:
Required:
• 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 five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
Preferred:
• Experience as a Senior Clinical Research Associate.
• 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 five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
• Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries.
• Thorough understanding of the drug development process.
Preferred:
• Experience as a Senior Clinical Research Associate.
Experience:
Required:
• Minimum of four (4) years of relevant clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
• In lieu of the above requirements, candidates with > five (5) years supervisory experience in a health care setting and four (4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered.
• In lieu of the above requirements, candidates with five (5) years of site management and/or study/project coordinator experience will be considered.
• Comprehensive understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Comprehensive understanding of both site monitoring and study site management requirements.
• Comprehensive understanding of applicable regional regulatory requirements.
• Ability to work with minimal supervision.
• Good planning and organization skills.
• Good computer skills with good working knowledge of a range of computer packages.
• Excellent verbal and written communication skills.
• Ability to lead and develop junior staff.
• Ability to understand and work with financial information.
• Ability to resolve project-related problems and prioritizes workload for self and team.
• Ability to work within a project team.
• Ability to work efficiently and effectively in a matrix environment.
Preferred:
• 1+ years additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
• Local project coordination and/or project management experience.
• Minimum of four (4) years of relevant clinical research monitoring experience (including pre-study, initiation, routine monitoring and closeout visits).
• In lieu of the above requirements, candidates with > five (5) years supervisory experience in a health care setting and four (4) years clinical research experience (including monitoring) in the pharmaceutical or CRO industries will be considered.
• In lieu of the above requirements, candidates with five (5) years of site management and/or study/project coordinator experience will be considered.
• Comprehensive understanding of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Comprehensive understanding of both site monitoring and study site management requirements.
• Comprehensive understanding of applicable regional regulatory requirements.
• Ability to work with minimal supervision.
• Good planning and organization skills.
• Good computer skills with good working knowledge of a range of computer packages.
• Excellent verbal and written communication skills.
• Ability to lead and develop junior staff.
• Ability to understand and work with financial information.
• Ability to resolve project-related problems and prioritizes workload for self and team.
• Ability to work within a project team.
• Ability to work efficiently and effectively in a matrix environment.
Preferred:
• 1+ years additional experience in a related field (i.e. medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing) is preferred.
• Local project coordination and/or project management experience.
Send resume to tehreem@jobs-n-jobs.com or tehreemshah279@gmail.com
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