Senior Technical Project Manager

hace 3 semanas


San José, San José, Costa Rica MSD A tiempo completo

The Sr. Technical PM is responsible for the oversight and management of the end-to-end delivery of technical data management components for one or more drug/vaccine programs. Provides technical consultation on the data management strategy, collaborates with appropriate functional areas to secure and align resources, and ensures all aspects of the technical project plan for in-scope studies are executed on time and with quality. Supports less experienced Technical PMs in the development of project plans which span from design and specification development through production deployment and subsequent change management support.

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Independently engages with cross-functional stakeholders to facilitate delivery of technical data management components based on knowledge of clinical database standards, technology, and program requirements. Serves as a program point of contact for any issues or concerns related to the development, maintenance, and consistency of technical components. Manages customer and stakeholder expectations. Represents Global Clinical Data Integration (GCDI) on cross-functional Global Data Management project teams.

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Participates in the development of, and ensures adherence to clinical data management procedures. Interacts with staff across multiple sites and external vendors.

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Provides technical consultancy to ensure that data from disparate sources and database structures align with the overarching clinical data management strategy. Participates in the development of, and ensures adherence to, clinical and regulatory data management standards.

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Able to work independently or as a team member or leader with equal effectiveness. Interacts with staff across multiple sites and external vendors. Mentors, guides, and provides project leadership for junior staff as assigned.

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Primary Activities

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Oversees the strategy and project plans for the development, testing and deployment of all technical deliverables (including, but not limited to, electronic Case Report Forms (eCRFs) data collector, edit checks, validation checks, IVRS integration, external data set-up and loading, Central Data Repository data flow). Works independently with different functional groups to ensure appropriate resourcing and coordinate execution of technical deliverables. Partners with functional area representatives to assess and promote program-level consistency in the use of database standards and program-level design. Provides program-related oversight and guidance to Technical PMs and promotes quality and consistency in the use of database standards and deliverables across trials within a program. Uses excellent interpersonal, negotiating, and project management skills to perform the following tasks

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Project plan development, execution, and change control

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Team facilitation and resource coordination

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Risk management

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Stakeholder management and communication including status reporting

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Keeps abreast of project management, technology and clinical data management disciplines through interaction with experts both within and outsid. Identifies and develops improvements to data collection and data management processes and tools. Supports audits and inspections as necessary. May lead a continuous improvement / technical enabling special project, including, but not limited to, data management improvement task force, automations, testing of new systems, any other task deemed appropriate by management. May serve as Technical PM for one or more trials within assigned programs.

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Education

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B.A. or B.S. degree, preferably in life sciences, computer science, or related discipline.**:

Experience

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At least 5 year of experience in Data Management. At least 3 years' experience working with formal project management tools and processes.**:

Demonstrated leadership and project management skills; strong organization, communication, negotiation, and problem-solving skills. Strong customer-focus and interacts effectively with different functional groups. Experience in assessing, developing, and/or implementing new technology capabilities preferred.

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Search Firm Representatives Please Read Carefully

Employee Status

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Regular

Relocation

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No relocation

VISA Sponsorship

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Travel Requirements

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Flexible Work Arrangements

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Shift

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Valid Driving License

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Hazardous Material(s)

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Requisition ID

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R266983
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