Data Management Project Lead
MedImmune - Gaithersburg, MD

This job posting is no longer available on MedImmune. Find similar jobs: Data Management Project Lead jobs - MedImmune jobs

There are currently two openings for this position.

Provide leadership in the planning and delivery of Data Management (DM) deliverables to time, cost, and quality and DM strategic direction to clinical projects in the use of DM standards and technology. Interface between the clinical project teams and DM Center to ensure seamless delivery of project DM components and adherence to MedImmune and project standards. The DM Project Leader will be aligned to one or more therapeutic areas dependent on size and scale of the project DM deliverables and will take global accountability.

~BSP

Position: * Serves as the expert in Clinical Data Management to provide support and advice to the clinical project team regarding the DM activities and deliverables to ensure effective delivery of the DM Center service. * Project related DM activities, technology and standards: o Ensure quality and consistency of DM components across therapeutic areas/programs. o Provide DM input to the development of clinical project standards and processes, including new concepts and techniques. o Ensure DM deliverables align with standards. o Provide DM and data collection expertise to study teams and development therapeutic area standards. o Provide DM business expertise and consultancy in the selection and use of software systems as appropriate. o Review project DM documentation and specifications as needed to ensure consistency with MedImmune strategies and standards. * Review, assess and manage DM Center delivery against KPIs and overall DM Center performance for studies. * Work with the DM Center, input to the production of the DM Service Order and study costs for studies being processed at the DM Center. * Ensure DM Center billing is accurate and manage invoicing process. * Initiate contract process for the database vendor and provide study team with estimated costs for hosting services. * Ensure study teams utilize standards by: o Working with study teams to understand and explain standards and escalates change requests to standards to the Standards Committee * Lead, coordinate and ensure transparency and consistency of MedImmune clinical study team and DM center activities including: o Provide the DM Center with MedImmune project planning information (scheduling of the studies, volumes, timelines etc.) o Facilitate DM related requests and issue escalation/resolution between MedImmune clinical study teams and the DM Center to meet study timeline and quality expectation o Monitor, manage and resolve escalated issues related to delays to DM Center deliverables by developing solutions to complex problems to ensure consistency across organization o Provide input to the DM related activities associated with regulatory inspections/audits * Assess MedImmune DM needs and improvement potential and recommend changes to the operating model * May be asked to provide strategic DM expertise to global Clinical Initiatives * May be asked to take on a global standards role as a member of the Standards Committee Education: * Education: University degree or equivalent experience * Minimum 6-8 years experience of working in Data Management in the Biotech/Pharma/CRO industry. * Demonstrated comprehensive knowledge and experience of most aspects of Data Management * Strong project management skills, communication skills, and interpersonal skills * Demonstrated leadership skills * Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP * Comprehensive knowledge or regulatory requirements as they relate to DM activities * Comprehensive knowledge of data standards, database structures and of capturing and storing clinical information * EDC experience strongly preferred

  • Education: University degree or equivalent experience * Minimum 6-8 years experience of working in Data Management in the Biotech/Pharma/CRO industry. * Demonstrated comprehensive knowledge and experience of most aspects of Data Management * Strong project management skills, communication skills, and interpersonal skills * Demonstrated leadership skills * Comprehensive knowledge of clinical and pharmaceutical drug development process and associated GCP * Comprehensive knowledge or regulatory requirements as they relate to DM activities * Comprehensive knowledge of data standards, database structures and of capturing and storing clinical information * EDC experience strongly preferred

MedImmune - 14 months ago - save job - block
About this company
72 reviews
MedImmune works to boost the immune systems of babies and grown-ups. Its flagship biotech product, Synagis, prevents respiratory syncytial...