Purpose:

The AbbVie R&D Device and Combination Product Development (DCPD) function provides device development expertise for Aesthetic Devices and Therapeutic Combination Products. Within this space, DCPD is accountable to enable AbbVie’s Early R&D Pipeline by providing support to AbbVie’s clinical cross-functional partners to ensure the successful inclusion of devices and drug delivery systems throughout the entire process.

We are seeking a Project Manager, Clinical Support, to spearhead initiatives to prepare for clinical trials involving devices and drug delivery systems and enable the early-stage pipeline. Collaboration with clinical teams is crucial in this role. You will play an integral part in coordinating efforts between clinical operations, clinical supply, clinical development, regulatory, quality, human factors, and the device development teams to ensure readiness for all phases of clinical trials.  These devices are often technically complex, involve multiple sub-systems, interface directly with the patient, and must meet global requirements. 

Responsibilities:

• Support clinical trial readiness activities for device and drug delivery systems, working closely with clinical supply, study teams, quality, and regulatory affairs to ensure efficient study initiation and adherence to appropriate standards and compliance.
• Coordinate device-related aspects of global clinical studies, including partnering with quality teams on complaint resolution, managing documentation, and ensuring compliance with regulatory reporting requirements.
• Collaborate with human factors, systems engineering, and device teams to support design validation planning and execution within design control processes
• Assist in the development and review of administration instructions for use in clinical trials. Contribute to the creation and implementation of training materials for clinical site staff and study teams in partnership with clinical development and operations.
• Author, review, or contribute to device sections for early-stage regulatory submissions.
• Advise clinical study teams to ensure appropriate representation and integration of device-related aspects in protocol design.
• Drive continuous improvement initiatives within device clinical management and across cross-functional teams, leveraging insights and feedback to optimize processes and enhance collaboration.