Clinical Research, Program Operations Pelzer

PERSONAL PROFILE

  • 14+ years in project management, clinical operations, and clinical trials; 12+ years of team management.

EXPERTISE

Drug Development; Clinical Trials Policy and Procedure Development; Database Creation and Management; Budget and Contract Development; Research and Medical Writing; CNS Neurology – Traumatic Brain Injury, Computer Tomography Imaging, Depression, Mild Cognitive Impairment (amnestic), Multiple Sclerosis, Peripheral Neuropathy, and Spinal Cord Injury; CNS Psychiatry – Alcohol Addiction, Bipolar, Depression, Drug Addiction, General Anxiety Disorder, Major Depression, and Schizophrenia; Oncology – Multiple Myeloma, Cancer, and Neuropathy.

PROFESSIONAL EXPERIENCE

Senior Project Manager, CNS Business Unit, Worldwide Clinical Trials

Managed all aspects of Phase 1 through 3 trials from start-up to close-out including major functional teams, program/trial budgets, change orders, and timelines. Provided contingency plans and alternative options as needed. Wrote and maintained project plans and oversaw site payments.

Senior Project Manager, CNS Business Unit, INC Research

Managed CNS global projects from proposal development to final deliverable. Was primary liaison with client to ensure successful study launch, conduct, and close-out. Participated on the enrollment task force, created fair market value site budgets and negotiation parameters, and managed the executed contract and financial aspects of the project, including reviewing study budgets and expenses. Created project process maps and timelines. Coordinated project organization, implementation, and management activities between company and client. Assisted in negotiations and contracting with outside vendors. Reviewed protocol documents, case report forms, and edits specifications for consistency. Developed and maintained study project plans to align with Standard Operating Procedures (SOPs) and Work Instructions (WI). Maintained and evaluated project progress with timelines and other tracking/analysis tools. Produced and distributed status, resourcing, and tracking reports. Prepared and presented study material at client meetings and communicated outcomes to project team. Led project team meetings, clinical committee, and clinical training sessions as per communication, project management, monitoring, and/or training plans. Supported business development in proposal development, providing information on company capabilities, patient populations, etc. Presented company capabilities as well as project management-specific responsibilities at customer proposal defense meetings.

Director, Clinical Operations, Oncotherapeutics, Inc.

Directed all clinical project management and operations for an oncology-specific CRO executing Phase 1-3 sponsor- and investigator-initiated, multi-center trials. Developed timelines and budgets, and managed tracking of study progress, including patient enrollment and selection and qualification of vendors and sites. Created client database with performance metrics to facilitate site selection. Developed SOPs and training materials for kick-off meetings and SIVs. Created processes to increase efficiency and workflow, introducing Lean management strategies. Brought continuity of brand to organization. Streamlined process for site monitoring, data collection, and querying. Participated in investigator meetings, trial development, and CRF creation. Oversaw and reviewed IND submissions and status reports to sponsors, IRB, and FDA. Directed project managers, scientists, in-house and remote monitors, and vendors. Oversaw data management, CRF and protocol development, and timelines.

Program Operations Specialist, Clinical Research Budgeting and Billing, University of Washington School of Medicine

Collaborated with research teams to create fiscally-sound budgets and compliant billing plans for oncology, surgery, and pharmaceutical/device studies. Negotiated budget contracts with commercial sponsors. Reviewed protocol and informed consent forms to create budgets and ensure compliance with institutional, agency, and federal regulations. Created and maintained clinical research budgeting and billing policies and procedures.