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Patients First. Powered by Evidence.
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• Provide the highest quality of customer service to patients and client representatives, which entail acquiring in-depth knowledge of client and marketing requirements • Complete verification of Benefits and Eligibility for all referrals from patients, medical doctor’s office (MDOs), health plans and pharmaceutical manufacturers • Investigation of benefits and eligibility by phone and/or internet to determine coverage choices patient has in starting on therapy • Review incoming referrals for completeness of and confirm FDA requirements are met as applicable • Answer all Incoming calls quickly and efficiently, evaluate their need and respond or disseminate call to appropriate member of team • Provide assistance with reimbursement inquiry requests, including insurance benefit verification, prior authorization, denials and appeals, and other reimbursement issues from patients, MDOs, payers and Sales Representatives • May provide billing and coding information related to specific product(s) • Conduct general payer research • Participate in call center activities, triage, and respond to incoming calls from patients, insurance companies, physicians, sales representatives, pharmacies, and homecare agencies • Maintain accurate and complete documentation of all inquiries in order to continuously improve the customer service process and reduce potential legal concerns • Identify and escalate repetitive questions and/or problems so that corrective action can be pursued and expedited • Responsible for good housekeeping techniques, adhering to quality and production standards while complying with all applicable company, state and federal safety and environmental programs and procedures • Other duties as assigned
• Monitors clinical trials and observational studies ensuring protocol adherence, managing site activities, and overseeing data collection and integrity. • Ensures sites are conducting the study(ies) and reporting study data as required by applicable regulations and guidelines, and sponsor requirements. • Mentors and trains junior level CRAs. • Performs remote and on-site monitoring in accordance with project specific timelines. • Completes travel scheduling in accordance with project specific and UBC travel policy. • Submits expense reports within UBC requirements. • Attends project team meetings, department meetings and one-to-one meetings with the manager. • Completes site monitoring reports and letters per UBC and/or sponsor SOPs requiring minimal corrections. • Ensures follow-up of site issues and action items per UBC/sponsor timelines. • Enters site visits, site monitoring reports, follow-up letter sent date and site contacts into UBC’s Clinical Trial Management System (CTMS). • Monitors within Electronic Data Capture (EDC) data entry, if applicable, and assists sites with electronic Case Report Form (eCRF) resolution. • Reviews Investigator Site File and performs Investigational Product reconciliation. • Maintains regular contact with assigned sites per study requirements. • Completes all SOP review, training assessments and documentation within requested timelines. • Assists Project Manager (PM) and management team by mentoring, training and assessing junior CRAs. • Assists with preparation and/or delivery of presentations for UBC CRA training, departmental training and/or sponsor specific training. • Assists PM and/or Lead CRA with additional tasks as needed. • Travel up to 80% required in the North American region.
• Fulfill general responsibilities with regard to hiring, training, resourcing, coaching, performance management, and functional delivery of respective staff. • Manage team of clinical operations professionals and promote an effective and collaborative environment in which best practices are shared. • Conduct hiring, training, and evaluation of staff. Ensure induction and orientation of newly hired staff. • Maintain oversight of productivity and quality metrics. • Provide ongoing coaching to each team member concerning quality, reliability, accountability, and productivity. • Oversee resolution of issues related to employee performance. Take formal actions to improve performance, when necessary. • Ensure key performance metrics, service levels, contractual obligations, and performance guarantees are met. • Understand revenue drivers and costs for the department and contribute to budgetary discussions, as appropriate, at each country level to ensure profitability. • Support cross-departmental training initiatives. Train and mentor new Clinical Managers. Serve as country level liaison for client issues.
• Monitors clinical trials and observational studies ensuring protocol adherence, managing site activities, and overseeing data collection and integrity. • Ensures sites are conducting the study(ies) and reporting study data as required by applicable regulations and guidelines, and sponsor requirements. • Mentors and trains junior level CRAs. • Performs remote and on-site monitoring in accordance with project specific timelines. • Completes travel scheduling in accordance with project specific and UBC travel policy. • Submits expense reports within UBC requirements. • Attends project team meetings, department meetings and one-to-one meetings with the manager. • Completes site monitoring reports and letters per UBC and/or sponsor SOPs requiring minimal corrections. • Ensures follow-up of site issues and action items per UBC/sponsor timelines. • Enters site visits, site monitoring reports, follow-up letter sent date and site contacts into UBC’s Clinical Trial Management System (CTMS). • Monitors within Electronic Data Capture (EDC) data entry, if applicable, and assists sites with electronic Case Report Form (eCRF) resolution. • Reviews Investigator Site File and performs Investigational Product reconciliation. • Maintains regular contact with assigned sites per study requirements. • Completes all SOP review, training assessments and documentation within requested timelines. • Assists Project Manager (PM) and management team by mentoring, training and assessing junior CRAs. • Assists with preparation and/or delivery of presentations for UBC CRA training, departmental training and/or sponsor specific training. • Assists PM and/or Lead CRA with additional tasks as needed. • Completes Site Management and Monitoring activities in accordance with project specific plans and timelines. • Assists with other duties as assigned, which may align with other departments at UBC.
• Monitors clinical trials and observational studies ensuring protocol adherence, managing site activities, and overseeing data collection and integrity. • Ensures sites are conducting the study(ies) and reporting study data as required by applicable regulations and guidelines, and sponsor requirements. • Mentors and trains junior level CRAs. • Performs remote and on-site monitoring in accordance with project specific timelines. • Completes travel scheduling in accordance with project specific and UBC travel policy. • Submits expense reports within UBC requirements. • Attends project team meetings, department meetings and one-to-one meetings with the manager. • Completes site monitoring reports and letters per UBC and/or sponsor SOPs requiring minimal corrections. • Ensures follow-up of site issues and action items per UBC/sponsor timelines. • Enters site visits, site monitoring reports, follow-up letter sent date and site contacts into UBC’s Clinical Trial Management System (CTMS). • Monitors within Electronic Data Capture (EDC) data entry, if applicable, and assists sites with electronic Case Report Form (eCRF) resolution. • Reviews Investigator Site File and performs Investigational Product reconciliation. • Maintains regular contact with assigned sites per study requirements. • Completes all SOP review, training assessments and documentation within requested timelines. • Assists Project Manager (PM) and management team by mentoring, training and assessing junior CRAs. • Assists with preparation and/or delivery of presentations for UBC CRA training, departmental training and/or sponsor specific training. • Assists PM and/or Lead CRA with additional tasks as needed. • Completes Site Management and Monitoring activities in accordance with project specific plans and timelines. • Assists with other duties as assigned, which may align with other departments at UBC.
Senior Project Director, Evidence Development Solutions – Oncology
UBCPatients First. Powered by Evidence.
• Provide strategic leadership, vision, and support to the project teams, ensuring alignment with the company's goals and client expectations. • Drive PM performance, project quality delivery, milestone timeline adherence, financial margin optimization, and customer satisfaction through efficient and effective directorship. • Ensure project teams prepare project plans to meet contracted services and timelines. • Engage in UBC cross-functional interactions to address project needs and drive problem resolution; facilitate the involvement of Senior Management as necessary. • Attend/participate in project internal / external meetings, and audits as needed. • Lead and mentor multidisciplinary project teams, including Project Managers, Operations teams, vendors, and other functional staff, ensuring effective communication, collaboration, and performance of project deliverables according to contract terms. • Work with cross-functional managers to ensure projects are adequately staffed and team members receive adequate training for specific job assignments. • Select, contract, and manage external vendors and subcontractors, when necessary, while maintaining quality and cost-effectiveness. • Monitor delivery of projects per scope and budgets, and demonstrate strong oversight of financial health for assigned projects. • Oversee project budgets, resource expenditures, and effectively drive compliance with forecasting, invoicing, revenue recognition, out-of-scope management, and contract modifications. • Proactive, ongoing identification of project risks and development of mitigating strategies to minimize their impact on projects effectively. • Ensure development and maintenance of risk management plans and risk assessments and categorization tools. • Serve as the UBC senior operational contact with clients for all project related items, maintaining strong relationships, addressing their needs, and providing regular project updates. • Ensure regular conduct of formal governance discussions to assess performance and drive issue resolution. • Implement quality control measures to maintain the highest standards of data integrity, patient safety, and protocol compliance. • Ensure activities on projects are delivered with adherence to project Plans, company policies and/or sponsor’s SOPs. • Be familiar with and ensure that all projects adhere to relevant regulatory requirements, data privacy provisions, and international guidelines (e.g., FDA, EMA, EU Clinical Trials Directives, ICH-GCP, GDPR, HIPAA). • Prepare, maintain, and deliver high quality project progress reports, metrics, and other outputs to clients and UBC senior management. • Ensure that project specific tracking metrics are developed, consistent with scope of work and project timelines. • Ongoing review of available dashboards and reports for assigned projects to ensure adherence to all required activities and operational / financial performance indicators. • Lead and drive specific business development opportunities: capabilities presentations, RFP review, proposals/budget input, bid defence participation. • Work with UBC Business Development to develop and grow UBC client relationships and maximum business opportunities. • Attend and present at conferences as required. • Responsible for the development, implementation, and project management process compliance for global projects. • Lead, innovate, and develop operational strategies that meet requirements and maximize project delivery success. • Identify, develop, and implement improvements to UBC processes, quality, and overall project delivery. • Engage in cross-functional collaborations with UBC leadership staff to optimize project delivery. • Contribute to UBC meetings, training activities, and cross-functional activities as appropriate. • Responsible for leading ongoing assessment of project delivery resource needs, including management of resource requests and oversight of department allocations aligned to utilization targets. • Implement creative resourcing solutions to maximize productivity and utilization of the team. • Manage the process of identifying/tracking staffing requirements and liaise with Human Resources regarding strategy, hiring, and onboarding project management resources. • Identify and develop UBC process improvements. • Prepare procedures, SOPs, guidelines and other standard materials for department. • Ensure staff are adequately trained on applicable SOPs, processes, and systems. • Ensure timely completion of timesheets and expense reporting by assigned staff. • Ensure timely completion of required UBC and project specific training by assigned staff. • Other duties as assigned by UBC Senior Leadership.
• Serve as a single point of contact for program specific Specialty Pharmacies (SPs), Specialty Distributors (SDs) and/or the manufacturer’s Sales Force • Responsible for reviewing, analyzing, identifying, and solving problematic issues and escalations • Provide timely and accurate reconciliation of SP and/or SD dispensing/shipping information • Builds and develops strong SP-HUB relationships, and support all activities that facilitate patient access • Identifies complex cases and triages them appropriately to the next level for support • Reviews the exceptions and restatement of SPP records • Serves as a point of escalation concerning prior authorization denials and/or appeals • Coordinates a delivery date for product, pump and supplies from the appropriate SPP to coincide with the patient's first day of titration or based on HCP/patient need
• Call Monitoring: Review incoming and/or outgoing patient, provider, client contacts and evaluate Advocate performance based on a standard set of criteria. • Provide Leadership Support: Provide onsite leadership support to Quality Representatives, Business Partners/Customers by providing floor support, answering questions, responding to leadership requests, presenting quality program/initiatives, etc… • Reporting/Trend Analysis: Analyze and provide weekly/monthly trending analysis to Management staff • Service Improvement Projects: Participate or lead projects to help drive quality improvements and/or expand services. • Calibration Sessions: Provide support to leadership by participating and hosting internal/external client calibration sessions. • Standard Works Support: Additional duties include but are not limited to taking phone calls, reviewing Source and emails, attending training, distributing monthly evaluations, etc. • Ability to travel as needed • Actively participates in in-person and virtual meetings/events (internal and external)
• Provide high quality customer service • Effectively interface with patients, patient’s families, national payers, home cares and medical doctor’s offices • Conduct benefit investigations, verify insurance benefits for patient and physicians’ offices • Submit and obtain prior authorizations as required by payer • Obtain recertification for cases requiring extended treatment/coverage beyond the expiration of original approval • Accurately enter and maintain data as required in client database and patient files • Utilize the client database to monitor outstanding items on each client case file • Ensure files are complete so team can determine the current status • Participate in conference calls as needed with Client Sales Representatives, client management and physicians’ offices regarding status of cases • Provide coordination of order for product, shipment of product, and therapy initiation with pharmacy and patient • Participate in Call Center Activities, triage and respond to incoming calls from patients, insurance companies, physicians, Sales Reps, pharmacies and homecare agencies • Educate patients, prescribers, and others regarding program requirements, and facilitate referrals • Maintain good housekeeping techniques, adhering to quality and production standards and comply with all applicable company, state, and federal safety and environmental programs and procedures
• Responsible for managing and driving the execution of assigned programs/projects, delegating responsibility to team members, project support resources, and core Patient Services leaders for driving change management. • Ensure quality and service standards are maintained along with client-specific contractual requirements. • Oversees the implementation of new requests from the client. • Foster ongoing client relationships by troubleshooting escalated issues, acting with authority, and communicating with transparency. • Responsible for managing the program level and corporate level financial targets, client retention, service level targets, performance reviews, business reviews, and development of Patient Services staff. • Develop and build leadership talent and capability within the team and direct reports. • Provide stretch learning and development assignments to leaders. • Ability to travel up to 50% to attend related client meetings/conferences as needed. • Actively participates in in-person and virtual meetings/events (internal and external).
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