Rani Maloney, Mba, Pmp, Rac Email & Phone Number

Providing Project Management consulting and leadership services for large and small pharmaceutical companies focusing on global asset development and strategy.

Greater New York City Area

East Hanover , New Jersey

Providing PM activities in the implementation of applications supporting clinical trial management• Created, tracked and managed project plans for multiple business work streams (Data Management, Training, Communication, Standards), identified issues and developed back up plans• Achieved the first release of the RAVE X project deployment six months ahead of schedule and within budget, through reorganization of resources and adaptation of schedules.• Identified stakeholders and implemented targeted communication across the organization via the communication plan• Coordinated communication with cross-functional teams and presented project status and risk analysis at Steering Committee meetings • Led workshops for multiple work streams across six business units and five different line functions. Managed 40-50 users in workshops• Provided guidance to the validation group to ensure testing strategy, test scripts, and testing met 21CFR Part 11 guidelines

Manager, Regulatory Compliance and Quality Management Nov 2010 – Jun 2013• Re-organized, improved and launched the company’s ISO 9001 program. • Created and executed the project plan and facilitated communication between project resources and participants • Ensured Health Authority inspection readiness - Hosted US FDA inspection in October 2012 with no 483 findings• Influenced key stakeholders and facilitated consensus among executive leadership regarding Quality Management System implementation• Provided timely and audience-specific status reports based on support of defined metrics to the Executive Team and other key stakeholders• Reconciled Executive Management’s expectations to align with FDA regulations and guidelines to ensure compliance • Coordinated external and internal audits and the customer complaint process, as well at trained internal auditors• Created CAPA program including development and use of metrics for root cause analysis and measurement of effectiveness of corrective/preventive actions• Acted as compliance liaison between external stakeholders such as the supplier and drug/food/cosmetic manufacturer• Wrote SOPs for Quality and Compliance functions, coordinated SOP development with other internal departments, and provided compliance training.

• Oversaw and managed all aspects of the QA program including: Authoring and reviewing SOPS, creating and providing company-wide ICH GCP training, vendor management, performing and approving internal and external audits, including follow-up, hosting sponsor audits and monitoring visits, review of clinical data for regulatory submissions and ensuring Health Authority inspection readiness for up to 70+ concurrent clinical trial studies.• Developed a Clinical Operations study lifecycle project plan– a proactive, risk-based assessment, including QA checkpoints, to identify and resolve potential issues• Managed the Health Authority inspection readiness program - Hosted US FDA Pre-Approval Inspection in August 2010• Reviewed and approved clinical study documentation for accuracy and compliance with GCP ICH regulations and guidance’s and internal procedures• Ensured computer systems were 21 CFR Part 11 compliant – Reviewed and approved computer systems and clinical studies validation documentation• Supervised, trained and mentored quality staff, including QA Specialists, Auditors and Document Control (seven direct reports). • Effectively utilized resources to meet the competing needs and aggressive deadlines from Clinical Operations, Data Management and IT• Developed and implemented tracking and trending procedures for data error rates, CAPAs and deviations to identify root cause trends – implemented preventive actions and process improvements• Communicated and managed relationships with functional and cross-functional team members to promote understanding as the QA representative on all operations project teams, standards committees and process improvements teams • Established the internal audit program for the organization, including the yearly audit and resource allocation schedule• Authored and communicated audit findings, conducted audit follow-up, and confirmed CAPA close-out• Developed documentation and data review guidelines

M.B.A

B.S, Environmental Science