Lead, PRO Specialist - United States
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its 125-year legacy.
- Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
- Our company is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company.
- Today, we’re doubling down on this goal. Our company Research Laboratories is a true scientific research facility of tomorrow, and will take company’s leading discovery capabilities and world-class small molecule and biologic R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
- Lead IVRS & PRO Specialist oversees the successful execution of the IVRS & PRO strategy for one or more drug/vaccine programs.
- Responsible for ensuring end-to-end support is provided to clinical project teams by the PRO team.
- Ensures all aspects of the IVRS & PRO 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 at a particular TA.
- Responsibilities include coordinating standards and oversight of consistency across compnay therapeutic areas.
- Identify areas for process improvement and lead improvement activities. Applies IVRS & PRO expertise to day-to-day activities when issues are escalated.
- Interacts with both technical and clinical staff to ensure their needs are met.
- Accountable for making decisions regarding IVRS & PRO process, issue resolution, and deviations from standards.
- Provide consultation on PRO modality, benefits, risks, costs, and process.
- Participates in the development of, and ensures adherence to, company clinical and regulatory data management standards.
- Develops / maintains relevant documentation, including applicable SOPs, job aids, and guidance documents. Defines process in collaboration with stakeholders and manages implementation plans.
- Serves as a IVRS & PRO Subject Matter Expert (SME) to internal & external stakeholders.
- Functions in the IVRS & PRO SME role independently and works to resolve conflicts that are complex, cross departmental, or external to the company.
- Independently prioritizes work activities to align with team objectives and/or current activities.
- Monitors Execution IVRS & PRO development process from Kickoff to system go live, ongoing system change control, system closeout and database lock activities.
- Responsible for performing cost / benefit analysis for IVRS & PRO projects, as appropriate
- Develops vendor-specific strategies for IVRS & PRO projects. Provides input to cross-vendor project strategies.
- Manages vendor performance and relationship(s). Responsibilities may include defining and implementing process with vendor representatives, monitoring and analyzing vendor and company performance metrics, performing root cause analysis and identifying corrective actions, and serving as point of escalation for vendor issues.
- May provide training and education for stakeholders. May develop, or assist in development of, reference and/or training material. May provide cross-functional internal and external communication as needed.
- Serves as program manager of all IVRS & PRO activities for compounds assigned. Uses excellent interpersonal, negotiating, and project management skills to perform the following tasks:
- Project plan development, execution, and change control. Coordinates resolution & risk mitigation of all IVRS & PRO related issues and end of study vendor deliverables
- Activity definition and sequencing, duration estimation, schedule development, and schedule control.
- Risk management planning (i.e., risk identification, analysis, and response planning, as well as risk monitoring and control).
- Communication planning, information distribution, performance reporting, and project closure.
- Obtain internal and external stakeholder feedback; this may include meeting with vendor project managers and/or meeting with subject matter experts or representatives from stakeholder functional areas.
- Analyzes data to identify areas for process improvements. Provides project leadership for process improvement activities.
- Responsibilities include managing requirement specifications, issue resolution, development of enhancements, and process changes.
- Provides support for problem resolution between IVRS & PRO vendors and company Clinical Trial Team
- May provide support for the development / maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documentation
- Mentors new and junior staff. May maintain training records and generate training reports as required for company staff.
- Lead a continuous improvement special project.
- Lead any other project or perform any other IVRS & PRO task deemed appropriate by management.
B.A. or B.S. degree, preferably in life sciences, computer science, engineering or related discipline.
- Minimum of 5 years’ experience in technology implementation (e.g. IVRS, EDC, ePRO etc), project management
- Effective written and verbal communication skills; ability to negotiate, resolve conflict and engage in decision-making with vendors, and influence across functional areas and organizations.
- Ability to lead cross-functional teams and organize / manage multiple tasks at one time
- Demonstrated leadership and project management skills; exceptional organizational, communication, and problem-solving skills.
- Proficiency with Microsoft Applications (MS Project, PowerPoint, Word, Excel)
Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement.