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jobs description

Job Description:

The Technical PM is responsible for the end-to-end project management and delivery of technical deliverables for assigned clinical trials within a specific drug/vaccine program.

Develops and manages technical project plans which span from design and specification development through production deployment and subsequent change management support.

Collaborates with appropriate functional areas to secure and align resources and ensure all aspects of the technical project plan are executed on time and with quality.

Under the guidance of more senior staff, engages with cross-functional stakeholders to facilitate delivery of technical data management components based on in-depth knowledge of clinical database standards, technology, and trial specific requirements.

Serves as point of contact for in-life maintenance of technical components, manages change requests as necessary, manages customer and stakeholder expectations, facilitates cross-functional decision making... and performs risk management.
Represents Global Clinical Data Integration (GCDI) on cross-functional Global Data Management project teams.

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

Primary Activities
• Develops detailed technical project plans for the development, testing, deployment, and maintenance of technical deliverables for assigned trials within a specific drug / vaccine program.

Technical deliverables include, but are not limited to:

electronic case report forms (eCRFs), data collection systems, system integration, edit checks, reports, and end-of-study archiving and decommissioning activities.
Facilitates the definition of trial-level technical requirements for quality data collection and validation by:
• Ensuring appropriate use of standards and project-level consistency of database design, data collection, and validation.
• Facilitating assessment and processing of standards and change requests
• Manages completion of clinical data management technical deliverables per study timeline and milestones, with appropriate quality.
• Ensures timely delivery of electronic case report forms (eCRFs), data collection systems, system integration, edit checks, and reports prior to patient enrollment
• Monitors overall status and quality of technical deliverables before and after release to production.
• Ensures timely decommissioning of clinical data management technologies.
• Under the guidance of more senior staff when appropriate, uses excellent interpersonal, negotiating, and project management skills to ensure timely and quality delivery of technical data management components

Exercises skills in:
• Project planning, initiation, execution, change control, and closing.
• Technical project team leadership, meeting management, and resource coordination.
• Risk management planning (i.e., risk identification, analysis, response planning, monitoring, and control), including escalation as necessary.
• Management of customer / stakeholder expectations; facilitation of crossfunctional decisions.
• Provides technical support for audits, as appropriate
• Identifies and supports improvements to data collection and data management processes and tools.

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

Experience:

At least 2 years of experience in Clinical Data Management and overall 5 years in Software Development or Technology Implemenation.
Experience with PM tools and PM certifications are desired.

Knowledge and Skills:

Experience in performing and/or managing database development and validation activities necessary to capture, manage, extract and report on clinical trial data.
Experience using project management tools such as Microsoft Project. Strong organization and leadership skills. Ability to manage in a complex, high paced environment with a sense of urgency and customer focus. Must be able to communicate effectively — orally and in written form — with both technical and business areas.

Search Firm Representatives Please Read Carefully

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:
R255768
Argentina

salary-criteria

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