Global Project Lead, Data Management

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Sep 03, 2020
Ref
R-114069
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time

About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

• Provides either leadership to, and management of a clinical program in a designated Therapeutic Area (TA) or is a team member within a function that supports the delivery of the portfolio. Fully accountable for all clinical program or functional deliverables. Functions supporting this activity includes Data Management, eClinical Operations, R&D Business Support, Clinical Programming as well as Performance Management.
• Executes the overall clinical and operational data for their study. Supports the entire data flow of studies to enable delivery of high-quality, consistent and integrated datasets for regulatory submissions. Where required, supports the broader R&D data strategy through systems and processes.
• Manages a system within the overall eClinical Technology suite of systems for the Therapeutic areas. For the system, translates business needs into the eClinical Roadmap. Implements, maintains and supports eClinical solutions. Configures and integrates eClinical solutions on project and study level. Applies Business Intelligence reporting to enable data driven decisions.
• Ensure all activities that support the TA model are successfully planned, implemented and completed in accordance with the TA strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
• Provides input to overall forecasts and management of budgets and resource allocation in collaboration with the Functional Heads and clinical teams.
• Supports the development of the processes, systems and standards to enable inspection readiness of all clinical studies as well as ensuring compliance with quality standards.
• Drives a culture of continuous improvement, always looking for ways to reduce cost and timelines, while maintaining the highest level of quality.

 

 



  • JOB DESCRIPTION

    -Provides either leadership to, and management of a clinical program in a designated Therapeutic Area (TA) or is a team member within a function that supports the delivery of the portfolio. Fully accountable for all clinical program or functional deliverables. Functions supporting this activity includes Data Management, eClinical Operations, R&D Business Support, Clinical Programming as well as Performance Management.

    -Executes the overall clinical and operational data for their study. Supports the entire data flow of studies to enable delivery of high-quality, consistent and integrated datasets for regulatory submissions. Where required, supports the broader R&D data strategy through systems and processes.
    -Manages a system within the overall eClinical Technology suite of systems for the Therapeutic areas. For the system, translates business needs into the eClinical Roadmap. Implements, maintains and supports eClinical solutions. Configures and integrates eClinical solutions on project and study level. Applies Business Intelligence reporting to enable data driven decisions.
    -Ensure all activities that support the TA model are successfully planned, implemented and completed in accordance with the TA strategy, appropriate international regulatory standards, and within the agreed timeframe and budget.
    -Provides input to overall forecasts and management of budgets and resource allocation in collaboration with the Functional Heads and clinical teams.
    -Supports the development of the processes, systems and standards to enable inspection readiness of all clinical studies as well as ensuring compliance with quality standards.
    -Drives a culture of continuous improvement, always looking for ways to reduce cost and timelines, while maintaining the highest level of quality.

    QUALIFICATIONS

    -Bachelor degree, or equivalent, in Science related discipline; Post graduate qualifications in scientific or business related field preferable.

    -7+ years experience working in clinical data management, statistical programming or clinical systems within the CRO/pharmaceutical environment.
    -Proven leadership and global Clinical Operations experience is essential.

 

 

 

 

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