noteworthy project summaries
Clinical Trial Support - Outsourced Specimen Collections
- Charged with contracting ancillary care and processing facilities in 22 target cities and providing ongoing oversight of laboratory specimen collection and processing functions.
- Made heavy use of Organizational Process Assets to understand requirements and define scope.
- Defined Scope, created Work Breakdown Structure and employed “Rolling Wave” methodology to develop schedule. Facilities would be identified, recruited and contracted as per client requirements.
- Cost estimates analyzed. Budget set and Cost Baseline Established.
- Designed and implemented customized database system to ensure data collection, specimen collection tracking and specialized trial reporting and data analysis.
- Contracted and readied facilities for trial participation, including auditing of facilities to ensure HIPAA, PI and IS Security policies were up to date as per Quality Assurance Plan.
- Organizational risks were identified and mitigated due to transference of liability to processing facilities. Vendors were compensated per specimen processed per the protocol. Any deviation would result in vendor correction without additional payment.
- Coordinated and scheduled equipment delivery, supplies and on-site training at each facility.
- Served as liaison and Point of Contact to all facilities on all matters through the duration of the project. This included technical direction involving specimen protocol.
- Instituted weekly quality assurance audits and daily quality control inspections to ensure quality.
- Provided and ensured daily, weekly communications and special reporting requirements.
- Managed invoice reconciliation and issued payments to facilities from onset to project closure
Lab Services Commercialization
- Contracted a national network of 600 Patient Service Centers to ensure service to client company patrons.
- Collaborated with client’s Project Champion and Key Stakeholders in multiple cities to collect requirements and define deliverables. Educated stakeholders on overall PM processes.
- Designed and developed custom database system to ensure specimen collection, data collection, production tracking and specialized reporting as per requirements.
- Designed and implemented claims processing procedures and workflows which had not previously existed.
- Performed extensive risk analysis and risk response and operational planning due to time sensitive nature of repetitive daily activities relative to specimen processing requirements.
- Collaborated with outside vendors and implemented “Just in Time” Inventory scheme and managed vendors to ensure just in time supply and materials.
- Instituted weekly quality assurance audits and daily quality control inspections to ensure quality.
- Established and managed Help Desk and Service Level Agreements for national network of facilities.
Outsourced Specimen Collection Services transitioned Client
- Lead all efforts to establish an 1100 member network of ancillary care providers to perform specimen collections in time for the test launch, ensure knowledge transfer and ultimately transition management of daily operations to the client's newly established Phlebotomy Services Team.
- Contracted and worked with outside call center to ensure client expectations for customer service levels were followed per agreed protocol.
- Advised Senior Management on establishment of IT Department vs. Outsourcing.
- Provided subject matter expertise to client's IT Team on matters of software design and development. This allowed them to develop an in house online management system for customer tracking, specimen collection and processing management as well as vendor management.
- Advised client's senior management team to develop budget and staff requirements for the establishment of Phlebotomy Services Department.
- Worked with Client Management to transition all provider contracts to the client and continued to liaise with client's senior leadership to provide day to day technical guidance on specimen protocol issues and questions until operations were stable.
Vendor Management
- Intended to test the feasibility of outsourcing the scheduling and just in-time fulfillment of physical examination and phlebotomy service requests.Underwent and passed Government mandated Information Systems Audit to ensure information security. This audit is required of all US Government vendors.
- Worked with client's senior leadership to define requirements for information security and specimen collection protocols with special routing.
- Designed and developed a custom case management system to accommodate highly specialized info security needs, protocols and communication requirements.
Provider Network Expansion
- Telemedical provider of physician consultations needed to quickly establish a brick and mortar network of physicians and a mobile nursing network to help fill gaps in coverage.
- Worked with client IT Director to create and develop seamless information interchange.
- Ensured daily requests for medical services were expertly handled and information reported.