Program Manager, Interactive Response Technology Systems (Hybrid)

Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Interactive Response Technology (IRT) systems & Clinical Outcome Assessments (COA Program Manager oversees the successful execution of the IRT & COA strategy for one or more drug/vaccine programs. Responsible for ensuring end-to-end support is provided to clinical project teams. Ensures all aspects of the IRT & COA project plan (from protocol development through system closeout) are executed on time and with high standard quality. Ensuring vendors are planning and managing timelines and employing risk management techniques across all programs. Responsible to have operational visibility across all studies for a particular TA.

Our Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.

Responsibilities include coordinating standards and oversight of consistency across our therapeutic areas. Identify areas for process improvement and lead improvement activities. Applies IRT & COA expertise to day-to-day activities when issues are escalated. Interacts with both technical and clinical staff to ensure their needs are addressed. Accountable for making decisions regarding IRT & COA process, issue resolution, and deviations from standards. Provide consultation on PRO modality, benefits, risks, costs, and process.

Primary Activities

• Develops / maintains relevant documentation, including applicable SOPs, job aids, and guidance documents. Defines process in collaboration with stakeholders and manages implementation plans.

• Effectively demonstrates key leadership standards.

• Serves as an IRT & COA Subject Matter Expert (SME) to internal stakeholders.

• Functions in the IRT & COA Program Manager role independently and works to resolve conflicts that are complex, cross departmental, or external to our company.

• Independently prioritizes work activities to align with team objectives and/or current activities.

• Responsible for performing cost / benefit analysis for IRT and COA projects, as appropriate.

• Develops vendor-specific strategies for IRT and COA projects. Provides input to cross-vendor project strategies.

• Analyzes data to identify areas for process improvements. Provides project leadership for process improvement activities.

• Makes decisions based on SOPs, working knowledge, available data and prior experiences. Makes decisions regarding IRT and COA standards used by trial teams, determines if deviations from standards are permissible, and provides final go/no-go decision regarding custom system changes.

• Facilitates study-specific requirements discussions or issue resolution with internal and external stakeholders when warranted.

• Responsibilities may include confirming/denying utilization of IRT and COA Systems, identifying current, and projecting future, IRT and COA demand; reviewing vendor proposals and participating in vendor selection and qualification.

• Manages vendor performance and relationship(s). Responsibilities may include serving as a vendor manager, defining and implementing process with vendor representatives, monitoring and analyzing vendor and performance m