Data Scientist

• Act as a lead data manager for one or more projects.
• Act as primary contact with the sponsor as required and communicate with management regarding all data management activities within their studies.
• Accountable for data management activities on assigned study projects from database start-up through database lock and CSR/submission.
• Serve as the primary data management contact for internal, sponsor and 3rd party vendor teams.
• Responsible for delivering quality data to the sponsors.
• Responsible for reviewing the revenue recognition workbooks with the Project Manager(s) when DM tasks are completed for each month/phase of the project to ensure client payments.
• Create and maintain the Data Management Plan and all other core DM documents (e.g., data review plans, data transfer plans, coding guidelines, CRF completion guidelines, database finalization and freeze/lock, etc.) for assigned projects and ensure they follow UBC SOPs.
• Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager.
• Ensure data management deliverables are met on time.
• Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities.
• Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables.
• Provide solutions for data management issues that arise during study conduct.
• Design and develop database build specifications (i.e., CRFs/ePROs, Visit/form configuration specifications, edit check specifications) to meet study data requirements per protocol.
• Develop data cleaning requirements for assigned projects.
• Distribute data review tasks to the data management team on the project.
• Coordinate and participate in all user acceptance testing (UAT) activities of study databases and external vendor systems.
• Develop documents and support Real World Evidence Projects (e.g., Feasibility Questionnaire, Variable Gap).
• Develop, track, analyse and report, as applicable, on data management performance metrics from study start to database lock and provide to project managers, sponsors, etc.
• Responsible for the adhering to project budgets and notifying project teams of the need for potential change order.
• Responsible for the training and support of project-specific DM staff on all data management operations and documents (e.g., CRFs/PROs/COAs/RWE designs, protocol, data cleaning process/query resolution) on an ongoing basis.
• Provide input during the development and/or review of Data Management SOPs, Work Instructions and templates/standards incorporating the industry's best practices and any applicable Regulatory guidelines and requirements.
• Participate in business development activities as required.
• Other duties as assigned by management.

Lead Data Manager

• Act as a lead data manager for one or more projects
• Act as primary contact with the sponsor as required and communicate with management regarding all data management activities within their studies
• Accountable for data management activities on assigned study projects from database start-up through database lock and CSR/submission
• Serve as the primary data management contact for internal, sponsor and 3rd party vendor teams
• Responsible for delivering quality data to the sponsors
• Responsible for reviewing the revenue recognition workbooks with the Project Manager(s) when DM tasks are completed for each month/phase of the project to ensure client payments
• Create and maintain the Data Management Plan and all other core DM documents (e.g., data review plans, data transfer plans, coding guidelines, CRF completion guidelines, database finalization and freeze/lock, etc.) for assigned projects and ensure they follow UBC SOPs
• Provide input on study timelines, identify risks, and communicate mitigation strategies to the Project Manager
• With oversight, ensure data management deliverables are met on time
• Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities
• Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables
• Provide solutions for data management issues that arise during study conduct
• Design and develop database build specifications (i.e., CRFs/ePROs, Visit/form configuration specifications, edit check specifications) to meet study data requirements per protocol
• Develop data cleaning requirements for assigned projects
• Distribute data review tasks to the data management team on the project
• Coordinate and participate in all user acceptance testing (UAT) activities of study databases and external vendor systems
• Develop documents and support Real World Evidence Projects (e.g., Feasibility Questionnaire, Variable Gap)
• Develop, track, analyse and report, as applicable, on data management performance metrics from study start to database lock and provide to project managers, sponsors, etc.
• Responsible for adhering to project budgets and notifying project teams of the need for potential change order
• Responsible for the training and support of project-specific DM staff on all data management operations and documents (e.g., CRFs/PROs/COAs/RWE designs, protocol, data cleaning process/query resolution) on an ongoing basis
• Provide input during the development and/or review of Data Management SOPs, Work Instructions and templates/standards incorporating the industry's best practices and any applicable Regulatory guidelines and requirements
• Participate in business development activities as required.
• Other duties as assigned by management

Project Manager

• Lead UBC projects to deliver project milestones and deliverables
• Oversee and coordinate project-related activities, with direct responsibility for ongoing tracking, management and follow-up of tasks and deliverables
• Manage project per the Scope of Work (SOW) and within the contracted budget (including consulting agreements)
• Serve as single point of contact for internal SERRM Scientists to facilitate consistent messaging to sponsors specifically for consulting services
• Ensure project is conducted according to UBC and Sponsor Standard Operating Procedures (SOPs)
• Serve as the UBC primary contact with Sponsor(s), including Project Management Office (PMO) projects representing Shared Risk Evaluation and Mitigation Strategies (REMS) consortiums comprised of multiple Sponsors
• Prepare or coordinate with an internal multidisciplinary team to develop deliverables
• Lead internal project and client meetings
• Present information at client meetings and internal project review meetings
• Track and communicate delivery and/or completion of project deliverables to monitor revenue recognition, invoicing, and follow-up
• Perform and catalog research, as assigned, related to current landscape of FDA approved products, related safety attributes, and regulatory process/nuances
• Support subject matter experts in the presentation of research to Sponsor(s)
• As necessary, working after business hours and on weekends may be required to ensure critical deadlines are achieved (e.g., FDA submissions)
• Other duties as assigned by management

Associate Project Manager – SERRM

• Plan, organize and lead UBC project teams to deliver projects based on client needs on time, on budget, and within scope
• Oversee all aspects of project conduct from start-up through close-out
• Execute operational aspects of assigned project activities as well as special projects
• Manage project per the scope of work and within the contracted budget
• Manage revenue and invoicing for project(s)
• Ensure project is conducted according to UBC SOPs and client SOPs as applicable
• Develop plans and processes to achieve contracted milestones (e.g. project plan, clinical management plan, monitoring plan, training plan, communication plan, compliance plan); monitor project progress against the established plans and ensure compliance with plans
• Prepare project timelines and prepare or coordinate development of deliverables
• Prepare project meeting agendas and create minutes and actions logs
• Ensure project budget is tracked against contract milestones
• Serve as UBC primary contact with sponsor
• Coordinate and facilitate all project meetings with internal and external stakeholders as necessary
• Focal point for resolving project team member questions
• Supervise all functional areas that support the project
• Lead projects with cross functional involvement and supervise all functional areas that support the project
• Ensure project training occurs and assist with training for project, as assigned
• Develop content and lead Kick off Meetings both internally and externally
• Negotiate budgets and assist with remediation of contract language
• Present project information at bid defenses, client meetings and UBC monthly project review meetings
• Maintain project documentation to be “audit ready”
• Participate in sponsor/regulatory audits as required
• Coordinate investigator meeting as required
• May be asked to assist in protocol development and/or patient/subject consent form or REMS and REMS Supporting Documents as required
• Help lead process improvement activities
• Establish, implement and track key metrics to report on progress of project and initiatives
• Coordinate and ensure maintenance of Trial Master File as required
• May be asked to perform CSS and CRA duties as needed
• Other duties as assigned by management

REMS Project Manager

• Oversee and coordinate project-related activities, with direct responsibility for ongoing tracking, management and follow-up of tasks and deliverables
• Manage project per the Scope of Work (SOW) and within the contracted budget (including consulting agreements)
• Serve as single point of contact for internal SERRM Scientists to facilitate consistent messaging to sponsors specifically for consulting services
• Ensure project is conducted according to UBC and Sponsor Standard Operating Procedures (SOPs)
• Serve as the UBC primary contact with Sponsor(s), including Project Management Office (PMO) projects representing Shared Risk Evaluation and Mitigation Strategies (REMS) consortiums comprised of multiple Sponsors
• Prepare or coordinate with an internal multidisciplinary team to develop deliverables
• Lead internal project and client meetings
• Present information at client meetings and internal project review meetings
• Track and communicate delivery and/or completion of project deliverables to monitor revenue recognition, invoicing, and follow-up
• Perform and catalog research, as assigned, related to current landscape of FDA approved products, related safety attributes, and regulatory process/nuances
• Support subject matter experts in the presentation of research to Sponsor(s)
• As necessary, working after business hours and on weekends may be required to ensure critical deadlines are achieved (e.g., FDA submissions)
• Other duties as assigned by management

Content Writer

• Provide leadership and management of Medical Writing group
• Lead programs and prepare Phase 1 through IV and post marketing regulatory documents including: clinical protocols and study reports, study synopses, IND, NDA and MAA submission documents, safety narratives, registry and observational study protocols and reports, risk evaluation and mitigation strategy (REMS) assessment reports, knowledge, attitude, and behavior surveys (KABS) reports, and abstracts/manuscripts for publication
• Ensure peer review and QC of regulatory documents for publishing according to standard operating procedures (SOPs)
• Participate in UBC and client project teams for project planning and development of timelines
• Coordinate/consult with other UBC departments such as SERRM, Data Management, Programming, Biostatistics, Quality Assurance, and Project Management on Medical Writing projects
• Lead preparation and review of departmental standard operating procedures (SOPs) to improve efficiencies and quality of processes
• Participate in requests for information (RFIs) and requests for proposals (RFPs) for business development opportunities

Senior Manager, Medical Writing

Associate

• Provide consistent customer service support to all stakeholders for the assigned program(s)
• Handle inbound and outbound contacts from various sources (patients, healthcare providers, etc.) related to a specific and/or multiple UBC programs, as applicable.
• Conduct communication through various channels (phone, fax, email) to retrieve data or to address discrepancies in data received.
• Complete full follow-up with regards to missing information from stakeholders, including data entry process, as applicable, documentation, and safety reporting per program guidelines.
• Apply corrections and/or updates in the secured program applications and/or CTMS and appropriate documents, which have been identified through data verification or follow-up calls.
• Escalate potential problems or issues that require management’s immediate attention and provide a summary with appropriate detail to his/her direct supervisor.
• Document all communications in the appropriate application contact log in an accurate, concise, and timely manner as defined in the Standard Operating Procedures and/or Project Specific Procedures.
• Ensure all assigned project tasks are completed.
• Review documents for program standards and take appropriate action.
• Other duties as assigned by the Program Manager, Associate Program Manager, Associate Manager, Coordinating Center, and/or Senior Manager, Coordinating Center and as determined by UBC SOPs.

Fixed-Term Coordinating Center Associate

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.
• 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 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.
• Travel up to 50% required in the European region.
• 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

• 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.
• 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.
• 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 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.
• Travel up to 50% required in the European region.
• Completes Site Management and Monitoring activities in accordance with project specific plans and timelines.

Data Analyst

• Build and maintain Tableau operational analytics dashboards.
• Manage all facets of supported analytics projects from new business award through launch.
• Build and mature business process, application, and data subject matter expertise for supported service lines and projects to serve as a highly-credible advisor to customer base.
• Manage supported analytics projects’ Tableau Server and SQL Server Reporting Services (SSRS) reports, dashboards, subscriptions, and extracts including failures, long-running processes and retirement monitoring.
• Support Analytics team and leadership with Snowflake, SQL, Tableau, and general analytics best practices.
• Support pharma client engagements as needed including periodic travel to UBC or client sites as needed (typically no more than once per quarter).
• Create and maintain excellent customer-facing relationships with Operations and clients.
• Present project status updates and state of the team to Analytics leadership on a regular basis.
• Take full ownership of execution and performance of assigned analytics projects.

Lead Data Analyst – IT

Medical 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.
• Lead and mentor multidisciplinary project teams, ensuring effective communication, collaboration, and performance of project deliverables according to contract terms.
• Select, contract, and manage external vendors and subcontractors, when necessary, while maintaining quality and cost-effectiveness.
• Monitor delivery of projects per scope and budgets.
• Demonstrate strong oversight of financial health for assigned projects.
• Proactive, ongoing identification of project risks and development of mitigating strategies.
• Serve as the UBC senior operational contact with clients for all project related items.
• 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.

Clinical Research Project Director

General

• 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

Eligibility Specialist

• Provide the highest quality of customer service to patients and client representatives
• 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
• May serve as single point of contact for an assigned group of prescribers
• Effectively manage and work though action item list to ensure it is current and tasks are completed in a timely fashion
• 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.
• 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 – Oncology

• 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.