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Clinical Data Manager III
Spring House, PA
6+ Month Contract
The job holder has the responsibility of supporting systems and optimizing approved technologies related to his/her area of responsibility to deliver on their potential in providing accessible and accurate data across GCDO thereby improving the user experience in managing and accessing data and delivering value to all stakeholders.
The job holder will be responsible for maintaining and optimizing existing data collection systems ensuring that they are meeting the requirements of customers across GCDO & TAs and are compliant with applicable regulations.
The job holder may be responsible for support in systems inspection readiness and provide expertise as necessary for FDA and other health authority inspections. They will also provide Project Management Guidance to study teams which includes but not limited to structure on framework on conducting a Medidata trial. Study startup and closeout guidance, migration support, tracking high level study milestone information and clinical view refresh when required. This team member will also guide study teams to documentation for reference and answer adhoc questions when necessary.
The job holder will contribute to initiatives to yield faster and more effective incident management, efficient change management services and will limit the number of systems interactions for the end users. In his/her area of responsibility, the job holder will be responsible to support continuous improvement framework with respect to systems deployment, project management and enhancements supported by greater partnerships with suppliers, CRO partners and industry user groups.
The Jobholder will have the ability to contribute to a high functioning diverse team to enable industry-leading electronic data flow. The jobholder will have technical expertise and significant experience gained through working with diverse and complex business processes and associated systems infrastructures.
The jobholder is responsible contributing to the Data Collection Solutions team active in the development, implementation, maintenance and continuous improvement of systems supporting GCDO's end to end processes.
The job holder will have responsibility supporting and maintaining business needs and optimizing the systems infrastructure related to data collection across GCDO by working with EBIS process data integration, data standards, integrated BI services teams, as well as GCDO IT, external partners and vendors.
The job holder may be responsible to contribute to the optimization of user management, content management, performance management and project management associated with all systems under his/her responsibility.
The job holder will be required to provide support for all clinical development systems supporting activities such as: data capture (inc. but not limited to: EDC, and integrated modules) and data integration.
The job holder may be required to provide Project Management Guidance on all aspects of conducting an EDC trial.
Contribute to a continuous improvement and innovation culture with respect to the current systems
infrastructure to optimize the user experience across GCDO and with internal and external partners.
Provide continuous process improvement in regards to Project Management framework of conducting an EDC trial.
The job holder could be responsible for distillation of best practices from leading organizations externally whilst also identifying best practices from internal
teams within Pharmaceutical.
This position reports to Head EBIS – Technology Platform Operations – Head of Data Collections Operations
The Jobholder may have the responsibility to train or mentor new members in the organization.
Participate in GCDO and cross sector initiatives as assigned.
Excellent problem solving and decision making skills
Strong planning, organizational and project management skills
Assist with Vendor management
Relate to the development and implementation of systems , main contacts in the organization are
• Head and team of Technology Platform Operations
• Head and team of Enabling Business Information Systems (GCDO)
• Team of Integrated Data, Analytics and Reporting (GCDO)
• Team of GCDO IT
• Team of Portfolio Delivery Operations (GCDO)
• Team of Global Clinical Operations (GCDO)
• Team RDO Innovation
Relate to the development and implementation of systems , main contacts outside the organization are:
• Other pharma companies in the context of pre-competitive collaboration
• Software vendors such as Medidata Solutions, ...
• Service providers such as CROs, Central Labs, BPOs, ...
• Industry User Groups (eClinical Forum,...)
Bachelor's Degree or relevant equivalent experience.
Project Management skills desirable.
Individual should have a relevant bachelors degree with a minimum of 5 years of experience working within systems covering clinical development in the Pharma sector, with at least 3 years working leading direct or matrixed teams at a management level.
Other relevant experiences and skills may be considered by the hiring manager when considering the candidate's eligibility.
• Analytical Ability /Quality Results Oriented
• Customer Focus
• Global Business Mindset
• Innovation & Transformation
• Internal and External Partnering
• Operational Excellence
• Project Leadership
• Process Enhancements
• Solutions Oriented
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Axelon Services, Corp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity, national origin, disability, or protected veteran status.