Accomplished Senior Operations Executive skilled in strategic planning, financial management and clinical operations leadership within the CRO industry. Experienced in managing day to day operations, including full P & L accountability, providing oversight of resources, developing, training and managing global clinical operational teams. Ability to institute creative improvements for more efficient workflow management, build effective teams and
Accomplished Senior Operations Executive skilled in strategic planning, financial management and clinical operations leadership within the CRO industry. Experienced in managing day to day operations, including full P & L accountability, providing oversight of resources, developing, training and managing global clinical operational teams. Ability to institute creative improvements for more efficient workflow management, build effective teams and increase profits. Strong leadership, communications, and negotiating skills.
• Global Clinical Operations
• Strategic Operational Planning
• Global Planning/Resource Planning
• Process Improvement
• Team Building & Leadership
• Employee Recruiting/Retention
• Operational Oversight
• P&L/ Cost Management
• Metrics Management
• Acquisition Integration
• Compliance and Regulations
• Vendor Management
Director of Clinical Operations @ From December 2015 to Present (1 month) Director, Strategic Partnership Development @ Lead collaborative review of processes and tools to guide project delivery via subject matter expert network. Liaise with client on development of partnership governance structure and member of the executive, operational and quality governance committee. Drive the development of manuals, guidance documents, process maps, etc. for documentation of agreements. Build and maintain strong relationships with client across all levels and therapeutic areas.
• Developed operational delivery plans for 3 major partnerships
• Established and lead global SME network for partnership accounts
• Organized and managed all aspects for client workshops to determine partnership delivery requirements and client touchpoints. Workshops involved > 100 participants for multiple days
• Selected to establish operating norms for major client for a commitment from highest level of executive team
• Ensured all processes and decisions were documented and ready for client audits and agency inspections
• Lead utilization identification effort for publicly announced resource acquisition From 2011 to September 2015 (4 years) Portfolio Director, PACE @ Served as the single point of contact, including direct operations, sales and business administration (finance, legal etc). Provided operational oversight of portfolio of studies for 2 large pharma clients
• Lead proposal development and determined strategic operational plans for delivery
• Awards included very large global trial worth > 100M From 2010 to 2011 (1 year) Executive Vice President @ Provide full day to day operational leadership, strategic direction and financial management to the CRO business unit. Accountable for monthly project financial and operational forecasts, cash flow analysis/payment schedules, gross profitability analysis, budgeting and resource management/utilization payment schedules, rate cards, volume discount arrangements. Review for the completeness, accuracy and delivery of all written responses to client-generated Requests for Information (RFIs) and Requests for Proposals (RFPs). Oversight for review and approval of all service agreements and amendments for all functional areas. Manage resource allocation and utilization across organization.
• Built clinical operations from a 12 person team to >100 in ~ 6 months; included management infrastructue
• Direct reports include: VP Clinical Operations; Director PVG: Head of HR; Recruiting Manager; VP of Business
Development; Administrative Support Staff. Dot-Line reports include: Director, Commercial Operations; VP of
Accounting; Director of IT From 2007 to 2009 (2 years) Executive Director Late Phase @ Lead the completeness, accuracy and delivery of all clinical services for awarded projects . Directly accountable for the development, leadership, and output of a team consisting of project managers, field CRAs, in-house CRAs, and administrative support staff. Directed line management, training, and career development. Provided expert review and guidance for production of departmental deliverables. Assisted executive management with various taskforce initiatives and served as a member of the acquisition integration team. Integration involved patient registries into late phase clinical trials department.
• Provided clinical operations leadership to the Late Phase operations group
• Developed bidding tools and proposal language specific to Late Phase projects and consulted on project design
• Determined implementation strategy and present at client presentations
• Provided management oversight to awarded late phase projects
• Integral member of acquisition team and integration process to broaden late phase expertise From 2005 to 2007 (2 years) Executive Director Late Phase Development @ Develop new clients and build relationships for repeat opportunities; Comprehensive responsibility for the coordination and operational procedures of the department; Provide oversight for general administration, communications, budget development, planning and project implementations. Additional areas of role included: business development, strategic planning and consulting with biotech and pharmaceutical companies on management and conduct of non-IND trials and large volume trials, resource management for fluctuating phases of the timeline. Negotiated contracts with clients including resource planning, materials management, and payment structure.
Participate in the requirements and selection process for the new CTMS. Serve on the design and development team for the global initiative. Global communications lead and charter member of the Executive Oversight Committee with the President and Vice Presidents worldwide.
• Built the Phase IV department which grew into the Late Stage Development department within 2 years
• LSD revenue directly contributed the 30% to the annual growth of the company in 2000
• Developed a staff of >150 permanent CRAs and PMs over multiply locations within 3 years with an additional 60+ contractors
• Established a global team for a 5,000 site Phase IIIb study employing local country specific CROs, independent contractors, staff from PPD Europe. Utilized call center approach with an in-house CRA team as well.
• Provided management and financial oversight to the largest clinical trials performed by company ($110 M total for the largest trial) From 1997 to 2005 (8 years) Associate Director Project Management @ Provide oversight to the RTP project management group administratively and project performance. Contribute to a standardized, metric driven timeline for all projects to utilize. Establish Project Management training course. Create project analyst position for efficiency and proficiency of timeline management within MS Project Managed large mega-trials across multi therapeutic disciplines on schedule and on budget. Supervise a diverse group of project managers and clients to achieve contractual obligations.
• Earned company >$1M bonus for project performance for a large mega-trial for a H2B inhibitor (penalty/bonus clause in contract)
• Awarded Employee of the Year 1994 by COO From 1993 to 1997 (4 years)
Bachelor of Science (BS), Nursing @ University of Southern Mississippi Mary Price is skilled in: CRO, Clinical Trials, Clinical Development, Clinical Research, Pharmaceutical Industry, CTMS, GCP, EDC, Oncology, Drug Development, Regulatory Submissions, Therapeutic Areas, Pharmacovigilance, Healthcare, Project Management
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