The Project Oversight Lead provides direct oversight, support, and coordination for assigned programs and projects within the department to ensure that all assigned Sponsor activities/tasks are worked on and/or escalated per Sponsor procedures.

The service will proactively communicate to Sponsor the status of the activities for assigned programs and projects to ensure services within scope are delivered according to Sponsor expectation. The service also partners with Sponsor to provide input to project/program assignments to support the portfolio and special projects. The service will lead cross-functional projects in a matrixed environment to ensure deliverables, timelines and escalation support are provided. The service will serve as a subject matter expert for assigned program and projects. Services include providing, as a core member of the Departmental Team, program management and cross-functional operational leadership for the delivery of services.

Further, this service will oversee that all projects and programs are delivered in compliance with the assigned clinical trial protocol, applicable company Standard Operating Procedures (SOPs), International Conference on Harmonization for Good Clinical Practice (ICH-GCP), Quality Oversight Plans (QOPs), regulatory requirements, and other department related requirements

Responsabilities:

• Services rendered will adhere to applicable Sponsor SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
• Deliver regular updates and insights to the departmental and leadership team of the status of projects/initiatives, highlighting operational or technical roadblocks and proactively proposing potential solutions for mitigation.
• Coordinate with the Departmental team members to ensure successful delivery of activities and tasks within scope (including project specific deliverables, key milestones, timelines etc.) and timely escalation and resolution of issues.
• Lead cross-functional, matrixed team; tracking project and program deliverables, timelines and provide escalation support. Proactively manages that deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through.
• Serves as a subject matter expert and escalation point for assigned program.
• Participate in and lead projects that advance department goals and objectives.
• Partner with SPONSOR Managers to review and provide input to portfolio and resourcing demand.
• Ensure documentation of team meetings, key decisions, action items, risks, and team communications are maintained and updated appropriately.

Qualifications

• Bachelor’s degree (University degree) or equivalent education / relevant experience required
• At least 6 years operational experience in (safety reporting (for GSMO only) for) clinical trials with a pharmaceutical company and/or a Clinical Research Organization is required
• Prior experience as an influential member of a cross-functional team is required
• Strong project management skills are required.
• Experience in mentoring and training
• Experience with team leadership/co-ordination in R&D functions is preferred
• Demonstrated knowledge of safety reporting (for GSMO), clinical development processes, global clinical operations, and/or strategic planning (not for GSMO) is required (depending on requesting function (EBIS, GSMO, …)
• Demonstrated knowledge of effective issue resolution and mitigation planning is required
• Ability to effectively provide oversight and coordination to programs and projects (including ATV and other high priority programs) that will meet all deliverables and timelines.
• Strong communication and presentation skills are required,
• Strong business partner collaboration and coordination is required
• Experience with team leadership/coordination, project management and/or functional line management in R&D functions is preferred
• Demonstrated knowledge of clinical development processes, global clinical operations, and strategic planning is required
• Familiarity with industry best practices for vendor management is required
• Good understanding of the therapeutic areas where Sponsor is involved is required Experience with Technology suppliers is preferred.
• Strong decision making and problem-solving skills required

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.