Research Analyst

• 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 Clinical Research Associate

Associate

• Develop content/proposal responses and/or pricing for related client Requests for Proposal (RFPs), Revisions, and RFIs across multiple UBC business segments
• Lead and coordinate Proposal Management activities with Sales/Business Development, Senior Management, functional departments, and Contract management
• Coordinate multiple groups and vendors in the preparation of client deliverables
• Develop proposal responses in response to client RFPs and RFIs in various formats as required by clients
• Develop applicable budgets responses in response to client RFPs and Revisions
• Partner with Client Engagement, Subject Matter Experts (SMEs), Operations, and Senior Management in the finalization of program documents, budgets, assumptions, and specifications
• Ensure all client deliverables are accurate
• Attend, participate and lead meetings as required
• Updates proposals and/or sales management tools, systems and/or forms regarding proposal or rebid status as needed
• Build strategy plans to guide internal team time management
• Contribute to Business Development initiatives
• Partner with the Contract Management team to coordinate hand-off process of final pricing, assumptions, and descriptions of services for won business
• Opportunity for cross-training in other service lines and roles/activities
• Other duties as assigned by management

Senior Associate, Proposal Development and Pricing

Director

• 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 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.
• Expected Project Load: PD Oversight of 6 to 8 projects, depending on scope.
• PD Oversight of up to 2 multi-study programs, depending on scope.
• Mentor, provide support, and direct supervision of Project Managers, Associate Project Managers, Project Associates, and other administrative staff.
• Conduct interviews for internal/external project management and operational candidates.
• Conduct ongoing performance review of assigned staff and remediate deficiencies.
• Conduct annual employee performance evaluations.

Senior Project Director, Evidence Development Solutions – Oncology

Pharmacist

• 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
• Support all activities that facilitate patient access
• Conduct teleconferences with each SP
• Provide ongoing communication with the SPP as needed to manage each patient case
• Identify complex cases and triage them appropriately to the next level for support
• Review the exceptions and restatement of SPP records
• Provide support for questions related to the sales portal
• Serve as a point of escalation concerning prior authorization denials and/or appeals
• Coordinate 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

Specialty Pharmacy Liaison

QA Engineer

• 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)

Quality Assurance Analyst – Call Center Monitoring

Reimbursement Specialist

• 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

Senior Reimbursement Specialist

Manager

• Oversee and manage the controlled documents lifecycle and corresponding test assessments
• Ensure compliance with internal policies and procedures and target review cycle frequency including appropriate formatting of SOP documents
• Support SOP review and approval process as deemed appropriate
• Oversee and manage training related activities (e.g. SOP table of content, training matrix, training decks, other training documentation)
• Oversee and provide assistance with CAPA administrative activities (data entry, effectiveness checks, process improvement, ensure process is managed in compliance with policies and procedures, etc.)
• Support and assist with GQC IT systems maintenance and change control (CAPA, electronic Document and Learning Management System, other)
• Oversee and manage the Regulatory/Client Audit Support functions
• Audit scheduling and audit calendar maintenance
• Meeting coordination/logistics
• CDA Requests
• Auditor Code of Conduct
• Setting up internal trackers and portals
• Setting up and providing secure Box access for auditor(s) when required
• Quality Compliance documentation review prior to and during audit
• Ensure audit reports and responses are stored as per UBC record retention procedures
• Provide administrative support (i.e., agenda, minutes, metrics) for the Global Quality Compliance department
• Assist in department-related special projects
• Other duties as assigned

Manager, GQC Support

• Provide day-to-day oversight and coordination of caseload to ensure all case elements and tasks are completed timely and ensure cases move through the process as required
• Act as single point of contact responsible for prior authorization and appeal processing communications to patients, healthcare providers, field reimbursement representatives and other external stakeholders
• Communicate patient benefits and responsibility timely and accurately
• Assess and refer patients appropriately for special programs/services when appropriate
• Performs quality checks on cases and report trends to leadership
• 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
• Troubleshoot complex cases, spanning multiple disease-states, while interfacing with key stakeholders (internal/external) to ensure optimal start to therapy
• Report Adverse Drug Events that have been experienced by the patient in accordance pharmaceutical requirements
• Recognize a product quality complaint and forward caller/written information to a manufacturer.
• Other duties, as assigned.

Case Manager – Reimbursement

General

• Provide high quality customer service
• Effectively interface with patients, patient’s families, national payers, home cares and medical doctor’s offices to assist patient and medical provider in expediting
• Conduct benefit investigations, verify insurance benefits for patient and physicians’ offices, and 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, drug orders and status of alternative funding
• 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
• May serve as single point of contact for an assigned group of prescribers
• Identify and report events as required by the REMS requirements for specified medication
• Recognize adverse event, product quality complaint, potential risk events, and forward information to the appropriate team member for reporting to the manufacturer
• 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

Program Manager

• Provide senior managerial duties overseeing the appointed coordinating center projects by overseeing the facilitation, managing, informing, training and recruiting of employees.
• Manage the design and implementation and account management of copay assistance programs for several specialty pharmaceutical programs.
• Ensure that all managers and associate managers are fully able to provide support to the associates who conduct incoming calls from the patients and the healthcare providers with the utmost customer service.
• Provide on-going analysis and evaluation of the effectiveness of appointed projects.
• Provide overall management and leadership of appointed projects.
• Serve as a client contact with external entities related to the project.
• Oversee appointed coordinating center managers for projects to ensure calls are made and support the escalation process.
• Provide managers with any issues or follow-up activities that need to occur with clients, participants within a project and/or employees in regards to daily responsibilities.
• Ensure that the managers have the tools to ensure customer satisfaction.
• Support efforts to deliver materials that are sponsor-authored instruction to ensure documentation of calls are accurate and concise.
• Support the appointed Project Manager in the creation of SOPs, project specific procedures and training materials.
• Support the appointed Project Manager in the creation and building of portal designs and other electronic data capture solutions.
• Ensure the projects are scalable for the current and future term.
• Assist business development with request for proposal information, call center expertise, and budget preparation.
• Other duties as assigned by the Senior Director, Operations and as determined by UBC SOPs.

Senior Manager – Program Operations, Copay Assistance

Conversion Rate Optimizer

• 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; 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.
• 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.
• Implement quality control measures to maintain the highest standards of data integrity, patient safety, and protocol compliance.
• Prepare, maintain, and deliver high quality project progress reports, metrics, and other outputs to clients and UBC senior management.
• Assist, as directed, on specific business development opportunities: capabilities presentations, RFP review, proposals/budget input, bid defence participation.
• 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.

Project Director, Evidence Development – Clinical Operations CRO

Clinical Research

• Manage projects as needed
• Work with Managers and Project Directors to ensure projects are adequately staffed; monitor workloads and adjust as needed.
• Assist, as directed, specific project opportunities in Business Development, RFP review and completion, and bid defense preparation and delivery.
• Present UBC capabilities to potential clients at bid defenses.
• Work with Business Development to ensure presentation of qualified team for bid defense and proposals.
• Provide input into proposals and review budgets.
• Ensure performance of project deliverables according to contract terms and company quality expectations, including accurate reporting and interpretation of metrics.
• Ensure project team members receive adequate training for specific job assignments.
• Develop and implement department structure and strategies based on current staffing and project needs.
• Ensure adherence to project Plans, company policies and/or sponsor’s SOPs.
• Work with staff (as needed) to plan and organize project activities.
• Ensure teams have consistency with completion of job-related tasks.
• Work closely with Managers and project teams to resolve operational issues.
• Report and discuss departmental, personnel and/or site issues with Senior Management, as needed, for possible resolutions.
• Conduct performance appraisals if assigned direct reports.
• Conduct staff interviews; assist with CV candidate review.
• Working knowledge of all active projects and timelines.
• Attend applicable team teleconferences/meetings as well as project reviews.
• Attend face to face client meetings and provide support, as needed.
• Attend finance meetings and perform necessary follow-up to resolution.
• Provide departmental update to senior management, as requested.
• Lead projects with cross-functional involvement and supervise all areas that support the project.
• Oversee all project revenue and invoicing with strong understanding of project financial health.
• Work with UBC's leadership and Business Development to develop and grow client relationships and business to maximum potential.
• Proactively serve as a resource and mentor to Project Managers and teams for problem resolution; facilitate the involvement of Senior Management as necessary.
• Proactively identify areas of improvement, provide solutions and execute plan of action to address.
• Lead Managers in client/regulatory audits, as required.
• Assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents, as required.
• Other duties as assigned by management.
• Direct project supervision of multiple Managers, including development of Managers in presentation and bid defenses, proposal and implementation of action plans, and ensuring Managers have a clear understanding of client needs once a project is awarded.
• Responsible for direct reports in addition to supervision of multiple Managers and projects as assigned, if assigned direct reports.
• Serve as a resource and mentor to the Managers in their daily activities.
• Proactively assist the Managers in anticipating and seeking resolutions to potential and actual project issues.
• Motivate project team members by fostering teamwork.
• Maintain positive attitude.
• Ability to plan and forecast potential issues, outcomes, and changes necessary to ensure program and developmental success.
• Ability to identify and optimize resources, inclusive of knowing when to identify and/or assign additional/or different resources.

Director, Clinical Research – REMS, BioPharma

• Manage clinical study contracts and budgets.
• Liaise with relevant project team, legal and other internal departments and sponsors to ensure contract management support throughout the life of the project.
• Plan, initiate, and negotiate contracts and budgets directly with study sites and physicians (as appropriate).
• Manage third-party vendors performing clinical contract negotiations on behalf of UBC.
• Serve as the primary operational contracts point person for assigned studies.
• Manage the preparation and contract negation process, including template development and translations, documentation of contract template and revision approvals, signature process, status tracking and reporting, scanning, filing and archiving original agreements.
• Directly interface with sponsor project management and legal to develop investigator grants/budgets, confidentiality and study agreement templates within UBC and sponsor legal and financial guidelines.
• Attend study team meetings, teleconferences, kick-off meetings, and investigator meetings, as necessary.
• Appropriately escalate UBC risks associated with study agreements, investigator payments and other operational vendor contracts.
• Maintain repository of operational contract templates as well as country specific budgets, requirements and timelines, and make available to project teams as needed.
• Monitor changes for potential template impact.
• Maintain repository of approved fallback language and apply as appropriate in negotiation process to accelerate closure.
• Contribute to and/or lead improvements to contract tracking tools, metrics reporting, operational effectiveness and investigator payment administration.
• Provide leadership and direction, including training, to project staff (internal and third-party vendor staff) in their communications with investigative site personnel regarding investigator agreements and budgets to ensure cooperative and effective communications between sites and UBC.
• Facilitate requests for pricing and narratives related to operational contract management and investigator payments for RFI/RFPs, client presentations or other UBC business needs.
• Approximately 10% travel required
• Other duties as assigned by management

Clinical Contracts Manager

Business Analyst

• Serve as the primary liaison between the business and IT.
• Lead business users, IT project teams, and external partners to drive decision making and define requirements for application development.
• Ensure that business needs are being met, defining and negotiating project scope.
• Create documentation of business requirements which guide application development efforts.
• Work closely with the business team, development team and quality assurance team to ensure successful implementation of business requirements.
• Collaborate with IT and business partners to resolve issues.
• Perform customized analyses of business and IS needs with an understanding of applicable applications systems, existing and future business processes, and pharmacy industry requirements.
• Perform analysis of compliance vulnerabilities; work with IT and Business teams to eliminate vulnerabilities, support internal and external audit related activities.
• Communicate project status and escalate issues as needed.

Senior Business Analyst

Risk

• Provide leadership in relation to Safety and Risk Management services, specifically risk management and REMS Consulting.
• Provide direction and oversight to relevant staff, as well as serving as a lead consultant for clients, partners or subcontractor relationships established for risk management and REMS Consulting.
• Serve as a key contact for clients and internal staff for interaction or governance around risk management and REMS Consulting activities.
• Provide daily management of the operational and financial activities related to risk management and REMS Consulting.
• Collaborate with Business Development leadership to support growth of the Safety and Risk Management business.
• Evaluate client requests for proposals and support proposal preparation for Safety and Risk Management.
• Prepare assigned Safety and Risk Management and other cross-functional team members for client bid defenses.
• Support sales process including: ongoing client relationship management, lead efforts to ensure proposal content is in line with client requests and UBC capabilities.
• Engage as a leader in client interfacing activities, identifying, and participating in conferences and public forum presentations to promote UBC capabilities.
• Promote cross selling of broad range of UBC products and services.
• Ensure project teams prepare project plans to meet contracted services and timelines.
• Oversee and manage quality, on-time deliverables related to risk management and REMS Consulting.
• Attend, participate and lead (as requested) client discussions.
• Assist in the delivery of programs by taking on billable work when appropriate.
• Assist in the development of creative and innovative solutions to meet client needs.
• Track contracts, financial activities, and resources utilization to maximize project profitability.
• Conduct regular 1:1 and team meetings. Conduct annual employee performance evaluations.

Senior Clinical Research Associate

Senior Associate, Proposal Development and Pricing

Senior Project Director, Evidence Development Solutions – Oncology

Specialty Pharmacy Liaison

Quality Assurance Analyst – Call Center Monitoring

Senior Reimbursement Specialist

Manager, GQC Support

Case Manager – Reimbursement

Senior Reimbursement Specialist

Senior Manager – Program Operations, Copay Assistance

Project Director, Evidence Development – Clinical Operations CRO

Director, Clinical Research – REMS, BioPharma

Clinical Contracts Manager

Senior Business Analyst

Senior Director – Risk Management, REMS Strategy