• 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.

Role Description - 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. Qualifications - Advanced Degree preferred, bachelor’s degree or equivalent experience required - Extensive project management experience at a CRO or proven leadership/management experience managing multiple projects and project teams (additional or other relevant management experience may be considered) - Strong knowledge of FDA/ICH regulatory guidelines; only applicable for Europe if required - Working knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics and regulatory/medical writing) - Mastery of project management skills with the ability to lead through change and independently lead multiple large projects simultaneously - Solid problem-solving and analytical skills with willingness and ability to detect process gaps, challenge assumptions, and drive change and improvement - Ability to work in a team environment under high-pressure situations - Excellent interpersonal, written, and verbal communication skills - Proven ability to interpret and prioritize customer needs - Strong influencing and negotiation skills - Takes initiative and is results and detail oriented - Ability to build strong business relationships across various departments - Broad therapeutic experience a plus - 10% travel as required - Extensive knowledge of Clinical Trial Monitoring, as required - Clinical background or equivalency in clinical research experience, as required - Proven knowledge of medical terminology - European/Global experience a plus - Advanced computer skills Benefits - Remote opportunities - Competitive salaries - Growth opportunities for promotion - 401K with company match - Tuition reimbursement (after 90 days of employment) - Flexible work environment - Discretionary PTO (Paid Time Off) - Paid Holidays - Employee assistance programs - Medical, Dental, and vision coverage - HSA/FSA - Telemedicine (Virtual doctor appointments) - Wellness program - Adoption assistance - Short-term disability (after 90 days of employment) - Long-term disability - Life insurance - Discount programs Company Description UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, or basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable, and inclusive culture that fosters respect for each other, our clients, and our patients.

• 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.

Role Description Under the general supervision of the Director of Quality Management, the Clinical Specialist Performance Improvement is responsible for ensuring compliance of assigned providers to federal, state, local, contractual, regulatory and best practices standards and guidelines. Principal Duties and Responsibilities: - Conducts reviews of Critical/Sentinel Events to determine if the incident meets the criteria and definitions for a critical event, critical incidents, risk events, sentinel event, or media events and is related to a practice or standard of care. - Classifies a critical event or incident as either a) sentinel event, or b) non-sentinel event. - Develops and updates the "MH-WIN Procedural Guidance Manual for Reporting Critical Incidents/Events, Sentinel Events and Death Reporting Process". - Documents and reports high profile, media-reported and urgent incidents that meet the critical incident criteria. - Develops Critical/Sentinel event face-to-face trainings for the provider network for accessing the Critical/Sentinel Event Module. - Reports ALL deaths (expected and unexpected) along with the appropriate information to MDHSS within 24 hours of knowledge. - Processes the closure of assigned deaths in the MH-WIN Module. - Provides oversight and management of Performance Improvement Projects. - Reviews investigations of records and information concerning the member including, but not limited to, the review of Individual Plans of Service (IPOS), progress notes, psychiatric evaluations, Behavior Management Plans, records of dispute resolutions, grievances and appeals, and recipient rights complaints. - Provides follow-up with providers for completion of root cause analysis or investigation; a) the findings shall include actions that will minimize the further occurrence of the sentinel event (per CMS approval and MDHHS current contractual requirement); or b) a written explanation providing the rational for not pursuing an intervention. A corrective action plan or intervention must identify: objective, measurable actions; who will implement the plan of action; a timeframe for the implementation; and how the implementation of the plan will be monitored or evaluated and submitted to DWIHN. - Maintains all materials as confidential and distributes only as necessary to perform the peer review function. - Ensures that all information related to the Critical Event is uploaded in MH-WIN using the Critical Event/Sentinel Event Module and placed into the "All Scanned Documents" tab. - Reviews Critical and Sentinel Events to include analysis and reporting of member experience and satisfaction with services provided allowing for integration with the Customer Experience process. - Works with the QI Administrator and Director to develop performance improvement targets for quality, service, and efficiency of the organization. - Implements changes targeted as systems improvement. - Measures and evaluates attainment of results. - Collaborates with other DWIHN units to ensure communication, teamwork and integration to support achievement of desired improvements. - Performs related duties as assigned. Qualifications - Knowledge of DWIHN policies, procedures and practices. - Knowledge of the principles of quality improvement. - Knowledge of Utilization Management. - Knowledge of Critical/Sentinel Event policies and procedures. - Knowledge of Quality Assurance. - Knowledge of accreditation and certification standards related to the provision of mental health, developmental disability and substance use disorder services. - Knowledge of the DWIHN provider network. - Knowledge of medical and behavioral health practices and terminology. - Knowledge of compliance standards. - Knowledge of the Medicaid screening process. - Knowledge of MDHHS policies, rules, regulations and procedures. - Computer skills. - Time management skills. - Organizational skills. - Critical thinking skills. - Teamwork skills. - Conflict Resolution skills. - Decision Making skills. - Project Management skills. - Assessment skills. - Report writing skills. - Communication skills. - Multitasking skills. - Analytical skills. - Ability to communicate orally. - Ability to communicate in writing. - Ability to work effectively with others. - Ability to work with an ethnically, linguistically, culturally, economically and socially diverse population. - Judgement/Reasoning ability. Requirements - A Master’s Degree in Social Work, Psychology, Counseling, the Human Services, the Social Services or a related field. - Three (3) years of professional experience in behavioral healthcare including at least (2) two years of experience in a community mental health setting and two years of experience in clinical practice. - A Valid State of Michigan clinical licensure: LMSW, LPC, LLP. - Must meet credentialing qualification in at least one of the following: Qualified Mental Health Professional (QMHP), Qualified Intellectual Disabilities Professional (QIDP), Qualified Children Mental Health Professional (QCMHP). - A valid State of Michigan Driver’s License with a safe and acceptable driving record. Working Conditions - Work is usually performed in an office setting but requires the employee to drive to different sites throughout Wayne County and the State of Michigan. - This position can work remotely with supervisory approval. - Currently this position is primarily a remote position. Please Note: DWIHN requires proof of being fully vaccinated for COVID-19 as a condition of employment. Medical or religious accommodations or other exemptions that may be required by law, will be approved when properly supported. Further information will be provided during the recruitment process. The Detroit Wayne Integrated Health Network is an Equal Opportunity Employer.