Clinical Research

• Accountable for the full spectrum of investigator engagement from identification and qualification through enrollment, and support database lock, and study closeout
• Serve as a clinical trial scientific ambassador, ensuring investigators deeply understand protocol intent, scientific rationale, and patient eligibility requirements
• Develop and sustain strategic, high-trust relationships with investigators that span trials and therapeutic areas
• Influence enrollment by co-creating tailored recruitment strategies aligned with site capabilities, patient population realities, and study objectives
• Proactively find opportunities to reach new patients, accelerate enrollment and increase impact at priority sites
• Capture and elevate critical insights from sites to optimize feasibility, protocol design, and study conduct
• Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data delivery
• Collaborate across functions and with vendor partners to resolve operational barriers
• Maintain advanced understanding of local treatment paradigms and standard of care to influence strategic country/site selection and protocol localization

Clinical Trial Liaison – Clinical Research Lead

• Accountable for the full spectrum of investigator engagement from identification and qualification through enrollment, and support database lock, and study closeout
• Serve as a clinical trial scientific ambassador, ensuring investigators deeply understand protocol intent, scientific rationale, and patient eligibility requirements
• Develop and sustain strategic, high-trust relationships with investigators that span trials and therapeutic areas
• Influence enrollment by co-creating tailored recruitment strategies aligned with site capabilities, patient population realities, and study objectives
• Proactively find opportunities to reach new patients, accelerate enrollment and increase impact at priority sites, including for example, novel site models, community-based research initiatives etc
• Capture and elevate critical insights from sites to optimize feasibility, protocol design, and study conduct
• Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data delivery
• Leverage performance metrics to anticipate issues, intervene decisively, and maintain momentum toward clinical milestones
• Drive inspection readiness as a continuous discipline across sites
• Collaborate across functions and with vendor partners to resolve operational barriers, ensuring delivery with speed and quality
• Maintain advanced understanding of local treatment paradigms and standard of care to influence strategic country/site selection and protocol localization
• Provide oversight and quality assurance for vendor monitoring, escalating risks proactively
• Cultivate a portfolio of strategically aligned, high-impact investigators who consistently prioritize client trials
• Enable an exceptional investigator experience by being a responsive, knowledgeable, and valued scientific partner
• Collaborate cross-functionally (e.g., Medical, Clinical, Study Delivery) to align on trial and site priorities, troubleshooting challenges with urgency and creativity
• Conduct data-informed site prospecting and prioritization, contributing to trial competitiveness and regional strategic execution
• Maintain scientific fluency and therapeutic expertise to lead meaningful, solutions-focused discussions with site personnel
• Act as a key liaison between field teams, vendors, and investigators, ensuring alignment, shared purpose, and continuous knowledge transfer
• Partner closely with field team colleagues to elevate the investigator and site experience, ensuring seamless collaboration and improving enrollment outcomes and Investigator relationships

• Accountable for the full spectrum of investigator engagement from identification and qualification through enrollment, and support database lock, and study closeout
• Serve as a clinical trial scientific ambassador, ensuring investigators deeply understand protocol intent, scientific rationale, and patient eligibility requirements
• Develop and sustain strategic, high-trust relationships with investigators that span trials and therapeutic areas
• Influence enrollment by co-creating tailored recruitment strategies aligned with site capabilities, patient population realities, and study objectives
• Proactively find opportunities to reach new patients, accelerate enrollment and increase impact at priority sites, including for example, novel site models, community-based research initiatives etc
• Capture and elevate critical insights from sites to optimize feasibility, protocol design, and study conduct
• Lead site-level strategy and risk planning to ensure strong and predictable enrollment and data delivery
• Leverage performance metrics to anticipate issues, intervene decisively, and maintain momentum toward clinical milestones
• Drive inspection readiness as a continuous discipline across sites
• Collaborate across functions and with vendor partners to resolve operational barriers, ensuring delivery with speed and quality
• Maintain advanced understanding of local treatment paradigms and standard of care to influence strategic country/site selection and protocol localization
• Provide oversight and quality assurance for vendor monitoring, escalating risks proactively
• Cultivate a portfolio of strategically aligned, high-impact investigators

• In collaboration with other members of the clinical research site team, works to support source document requirements for assigned studies.
• Creation of source documents that will follow GCP Guidelines and 21 CFR Part 11 Compliance in addition to internal SOPs.
• Create templates, worksheets, supplemental source for visits based on detailed review of protocol-defined exams, tests, evaluations, and assessments.
• Initial creation of source documents will use all available protocol specific documents (i.e., current IRB approved protocol, blank or annotated CRF, Sponsor provided source templates/worksheets, or reference manuals) to create a source document that is accurate and complete and to ensure that the source document is equipped to record all the required data for the visit.
• Creating, maintaining, updating, control, and release source documents, including paper and electronic source documents in line with the study protocol, and relevant sponsor guiding documents.
• Reviewing draft source and ensuring it is accurate and complete and to ensure that the source document is equipped to record all the required data for the trial.
• Coordinating initial source review and update process.
• Filing, maintaining, distributing, organizing, and archiving source documents for each clinical trial.
• Updating current source documents according to new clinical study protocol amendments.
• Activating studies and visits at the appropriate time.
• Supporting Quality Control (QC) of source documents before it goes to the users.
• Attending all relevant meetings to stay up to date with upcoming studies, progress on current studies, and studies closing out.
• Maintaining a single tracker for the department to track source document design activities and the status of the activities.
• Maintaining version control of all source documents.
• Managing daily communication with site staff and other internal departments.
• Remaining up to date with all assigned Clinical Study Protocol for study.
• Developing and maintaining excellent working relationships with internal and external clients to understand and meet their needs in line with company policies and procedures.
• Maintaining a positive, results-oriented work environment, building partnerships within the team and across the organization at large, and modeling teamwork.
• Participating in continuing education activities to maintain current knowledge of source document design and relevant software.
• Performing all other duties that may be requested or assigned.

Clinical Research Source Development Coordinator

• Responsible for the implementation of clinical trial activities per study protocol.
• Works closely with investigative site personnel, CROs, and other study vendors.
• Manage study contracting, budget and payment process for all clinical trial vendors including investigational sites.
• Design study related documents, including but not limited to study protocol, informed consent forms, CRFs, and regulatory binders.
• Train CROs, vendors, investigators and study coordinators on study protocol and relevant requirement.
• Monitor and track clinical trial progress and provide status update to stakeholders.
• Partner with other research and development groups to achieve deliverables.
• Mentor junior clinical operations staff and supervise clinical study team.
• This role works with PHI on a regular basis both in paper and electronic form and have an access to various technologies to access PHI (paper and electronic) in order to perform the job.

Senior Clinical Trial Manager

• Serve as a day-to-day operational point of contact for assigned CROs and vendors, tracking study deliverables and timelines and flagging risks or delays to clinical operations leadership.
• Review CRO-generated study documents for completeness and quality, including monitoring visit reports, site correspondence, protocol deviations, and TMF entries.
• Support the coordination of study startup activities, including site activation tracking, regulatory document collection, and vendor kick-off preparation.
• Maintain and update study trackers, timelines, and action logs; ensure cross-functional teams have visibility into study status and open items.
• Attend and support cross-functional study team meetings; document meeting minutes, track action items, and follow up on outstanding deliverables.
• Track and triage protocol deviations reported by CROs; coordinate with vendors and internal teams to ensure timely documentation and resolution.
• Support safety reporting coordination, including tracking SAE/SUSAR notifications and ensuring timely distribution to sites and relevant stakeholders in line with vendor responsibilities.
• Monitor TMF completeness and support inspection readiness activities, working with CROs to resolve filing gaps and maintain document quality standards.
• Assist with IRB/IEC tracking across study sites, including monitoring approval status for amendments and annual renewals submitted by the CRO.
• Compile and distribute enrollment, site performance, and operational metrics to clinical operations leadership on a regular basis.
• Contribute to data reviews as needed, and track data cleaning progress performed by CRO.
• Review and track monitoring visits and monitoring visit reports performed by CRO to ensure high quality and adherence to the monitoring plan.
• Support vendor invoice review and budget tracking by reconciling CRO invoices against contracted activities and flagging discrepancies.
• Coordinate data reconciliation activities at key study milestones in collaboration with data management and the CRO.
• Support the onboarding of CTAs joining the study team and serve as a resource for day-to-day study questions.

Clinical Trial Manager

• Provides advanced financial, accounting, and operational support by managing complex fiscal activities.
• Serves as a key resource to departmental leadership, faculty, and staff.
• Oversees budgeting, forecasting, financial reporting, procurement, and internal controls.
• Evaluates departmental fiscal processes, identifies opportunities for improvement, and implements changes.

Senior Financial Operations Analyst – Center for Clinical Research Management

• Join our Clinical Surveillance & Training (CST) team as a Clinical Scientist
• Lead Rater Training Excellence: Design and deliver scientifically grounded rater training programs to ensure consistent, high-quality endpoint assessment and reduce variability across sites
• Drive Patient Eligibility Quality: Perform comprehensive eligibility reviews, providing a second level of scientific oversight to confirm appropriate patient selection and minimize protocol deviations and safety risks
• Deliver Data-Driven Insights: Analyze clinical and endpoint data to identify trends, variability, and potential risks—translating findings into actionable insights that improve study execution
• Shape Protocol Strategy: Partner with sponsors and study teams to review protocols and provide expert guidance on endpoint strategy, scale selection, and study design feasibility
• Act as a Scientific Leader: Collaborate cross-functionally with clinical operations, medical, and sponsor teams to proactively identify risks and deliver solutions that protect study integrity

Clinical Scientist – Clinical Surveillance & Training, Clinical Psychologist/Neuropsychologist

• Collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
• Challenge the status quo with us in a highly competitive and ever-changing environment.

Senior Biostatistician

• Serve as a member of the central services team to deliver pharmaceutical support.
• Ensure delivery of therapeutic medication monitoring, EMR regimen build and review, protocol management.
• Provide drug information, dosing, monitoring, and education for safe medication therapy for patients in clinical trials.
• Collaborate with Research Department staff for quality patient care.
• Perform administrative and communication responsibilities for clinical trials.
• Support the development of new research regimen builds and inquiries.

Oncology Clinical Research Pharmacist

• Provide scientific leadership and independent contribution to study design, protocol development, and clinical development planning
• Support the development, implementation, conduct, oversight, and reporting of clinical trials
• Perform comprehensive literature reviews and maintain current knowledge of relevant disease areas
• Participate in the review and interpretation of clinical data
• Collaborate cross-functionally with Clinical Operations, Data Management, etc.
• Draft and contribute to clinical and regulatory documents
• Support or lead scientific interactions with CROs, investigators, and external collaborators
• Develop and maintain productive relationships with external scientific experts

Clinical Scientist 2, Clinical Development

• Provide scientific leadership and independent contribution to study design, protocol development, endpoint strategy, and clinical development planning for assigned programs.
• Support the development, implementation, conduct, oversight, and reporting of clinical trials, ensuring scientific quality and alignment with program objectives.
• Perform comprehensive literature reviews and maintain current knowledge of disease areas, competitive landscape, emerging science, and regulatory developments relevant to assigned products and indications.
• Participate in the review, monitoring, summarization, and interpretation of safety, efficacy, pharmacokinetic, patient-reported outcome, and other clinical data to support development decisions and recommendations.
• Collaborate cross-functionally with Clinical Operations, Biometrics/Biostatistics, Data Management, Pharmacovigilance, Medical Writing, Regulatory, Translational Development, Medical Affairs, and other partners to support high-quality study execution and documentation.
• Draft, review, and contribute to clinical and regulatory documents, including study protocols, synopses, investigator brochures, clinical study reports, health authority submission content, briefing materials, abstracts, posters, and manuscripts.
• Support or lead scientific interactions with CROs, investigators, site personnel, and external collaborators to ensure consistency, scientific integrity, and effective study execution.
• Contribute to advisory boards, expert meetings, and other scientific interactions that support program development and evidence generation.
• Support the development of departmental processes, templates, standard operating procedures, and best practices as needed.

Clinical Scientist 3, Clinical Development

• 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

• Oversees all aspects of study coordination and study conduct for multisite investigator-initiated studies.
• Serves as the primary contact for external subsites on all project-related operational matters.
• Collaborates with Principal Investigator (PI) on project design and development of study protocol and informed consent form (ICF).
• Completes all regulatory submissions including Protocol Review and Monitoring Committee (PRMC), Institutional Review Board (IRB), Data Safety Monitoring Committee (DSMC).
• Coordinates with Clinical Research Subsite Navigators.
• Creates the electronic data capture (EDC) system in collaboration with developers.
• Generates subsite data completion metrics for distribution to subsite PIs and study teams.
• Develops and implements a project-specific monitoring plan.
• Performs remote monitoring visits to review data timeliness and accuracy.
• Plans subsite Site Initiation Visits (SIV).
• Prepares and presents study metrics, progress, and long-term goals at Steering Committee meetings.

Clinical Research Project Associate

• Responsible for the collection, accuracy and validity of clinical research data for assigned clinical studies
• Performs a variety of complex activities to appropriately compile, document and analyze clinical research data
• Coordinates all aspects of study subject care from pre-screening through study completion as defined by the protocol
• Protect the rights and the well-being of subjects enrolled in studies
• Ensures thorough, individualized, protocol-based study subject education on all study process requirements
• Regularly evaluates the study subjects’ condition and communicates/documents concerns to PI
• Accurately documents study subject activities as outlined by the protocol

Clinical Research Coordinator II

• Support the overall operational execution of clinical studies on one or more clinical programs from initial study synopsis through final project deliverables (ie, database hard-lock, final TLFs, CSR, etc.)
• Manage the implementation, on-time execution and conduct of clinical studies; including the development of budget items, milestones and timelines, in addition to scope and management of resources (including vendor selection). All leading to overall quality, safety, and compliance throughout the duration of the clinical studies and program.
• Oversight of cross-functional study team members to ensure initiation and execution of the clinical program within approved budget and timelines
• Risk management and mitigation including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished.
• Lead role in vendor identification/qualification/selection, systems set-up/management including EDC, IWRS, Central Laboratories, specialty services (ePRO, eDiary, etc.)
• Understanding of how to support and deliver the trial endgame, which is the data and statistical analyses
• Critically assess data to detect trends and outliers to efficiently direct resources and attention to correct problems early
• Ability to critically review and supervise a multifunctional vendor groups including clinical operations, data management and biometrics
• Ensure data integrity through routine data reviews, query and resolution, consistency checks both internally and for independent DMC/DSC
• Effectively tracks and communicate program/study progress to Senior Management with ability to create and update detailed dashboards and trackers
• Awareness of competitive landscape, changing regulations and guidance with ability to assess the impact on clinical projects and make modifications as necessary
• Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

• Develops and executes country-level site engagement strategies aligned with internal priorities.
• Conducts early, strategic landscaping and site engagement (in-person or remote).
• Builds deep, multi-stakeholder relationships at strategic sites.
• Serves as the local escalation point for study challenges.
• Partners seamlessly with internal teams and CROs to ensure unified site communication.
• Manages assigned local/global clinical studies by overseeing CRO performance.
• Focus on driving adoption of DCT and digital solutions with our sites.

Clinical Research Engagement Lead – Central Region

• You will bridge the gap between strategy and execution across the entire trial lifecycle—from early development to late-stage delivery—ensuring our clinical assets are executed with maximum speed, efficiency, and clinical quality.
• Develops and executes country-level site engagement strategies aligned with internal priorities.
• Conducts early, strategic landscaping and site engagement during the protocol concept and study set-up phases to identify optimal sites.
• Builds deep, multi-stakeholder relationships at strategic sites.
• Serves as the local escalation point for study challenges.
• Partners seamlessly with internal teams and CROs to ensure unified site communication.
• Manages assigned local/global clinical studies by overseeing CRO performance and mitigating timeline or operational risks.
• Focus on driving adoption of DCT and digital solutions with our sites.

• Handles or assists with administrative activities generally associated with the conduct of clinical trials
• Maintains data pertaining to research projects, completes source documents/case report forms, and performs data entry
• Assists with patient recruitment
• Attends study meetings
• Orders and maintains equipment and supplies
• Reviews medical records and/or conducts screenings for recruitment of study participants, performs interviews and QOL questionnaires
• Collects study specimen according to protocol which may include phlebotomy, processing, and preparation for shipping
• Coordinates services, schedules procedures, creates and maintains case packages, and monitors charges
• Assists with quality assurance and tracks regulatory submissions
• Performs related approved responsibilities as required

Clinical Research Coordinator I – Cardiology

• Partner with medical for publication strategies, HEOR or economic modeling inputs
• Provide statistical expertise in analyses using external control and/or synthetic control, meta-analyses, and causal inference analyses, e.g. propensity score matching method
• Contribute to manuscripts, abstracts and presentations
• Collaborate with HEOR to align analyses with HTA agency expectations
• Review protocols for real world evidence studies
• Work with statistical programmers to conduct ad hoc analyses; Conduct quality review of statistical analyses
• Perform statistical programming for advanced statistical methodologies and help statistical programmers QC their programs
• Review relevant medical literature
• Write statistical analysis plans
• Develop TLF shells and review programming specs

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Senior Biostatistician

Oncology Clinical Research Pharmacist

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Director, Clinical Research – REMS, BioPharma

Clinical Research Project Associate

Clinical Research Coordinator II

Clinical Trial Manager

Clinical Research Engagement Lead – Central Region

Clinical Research Engagement Lead – Central Region

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