• Develop and foster relationships with senior Care Management leadership through ongoing collaboration on process improvement initiatives related to operational efficiency, workflow management, and analytical support. • Oversee departmental projects, including identifying initiatives, developing project plans and timelines, and managing project work through completion. • Lead interdepartmental meetings, serving as a subject matter expert and educator to promote cross functional understanding of Care Management workflows and processes. • As needed, oversee and conduct regular internal audits of clinical staff performance, evaluating adherence to Care Management standards, regulatory requirements, and organizational policies, and provide feedback on performance gaps to staff leadership. • Ensure Care Management training meets all standards set forth by the National Committee for Quality Assurance, Healthcare Authority, Centers for Medicare and Medicaid Services, and other applicable regulatory bodies. • Collaborate with leadership to develop and implement new programs and enhance existing programs, including participation in and leadership of division-level initiatives in addition to Care Management-specific activities • Participate in internal cross functional teams to ensure care management programs meet regulatory and compliance requirements. • Serve as a resource and support for more junior Program Managers, delegating responsibilities as appropriate to help broaden team skillsets and balance work efforts within the department. • Serve as a liaison between data analytics staff and Care Management leadership to develop or modify care management reports used to assess productivity and program outcomes. • Produce care management reports and present findings to applicable leadership and or committees. • Identify opportunities to standardize and improve care management processes and partner with leadership and staff to implement efficient desk procedures across lines of business. • Perform other duties as assigned.

Role Description The Associate Director, FSP Clinical Operations is responsible for the following: - Direct line management of FSP Clinical Operations managers and staff, and oversight of Client accounts. - Supporting FSP Clinical Operations business objectives, including ensuring on-time/high quality deliverables. - Resourcing Client projects with qualified staff, and working to retain and develop staff. - Promoting new business by participating in project bids and Client presentations as appropriate. Key Accountabilities - Program Management - Responsible for execution and oversight of Program Management activities related to one or more programs. - May serve as central point of contact (POC) for and between Senior Management and key Client personnel for contracted FSP Clinical Operations activities. - Plans and manages logistics, infrastructure, and resources related to FSP services to meet Client needs/timelines/deliverables. - Collaborates with Client to implement and operationalize short- and long-term strategies. - Develops and manages Communication and Escalation plans/processes, as applicable. - Oversees Client Governance as required; prepares/presents at meetings as applicable. - Oversees performance management of staff who support contracted FSP activities and collaborates with FSP Clinical Operations Management to ensure staff are technically proficient and able to satisfy Client expectations and deliverables. - Manages compliance with Client Key Performance Indicators (KPIs), utilizing applicable tools and systems to collect, track, and analyze associated data. - Leads Client-specific FSP meetings with internal program team, ensuring that contractual requirements related to FSP Clinical Operations activities are met and monitored on an ongoing basis. - Oversees and/or manages issue escalation and resolution, including corrective and Preventive Actions (CAPA) development when necessary. - Line Management - Manages and oversees FSP Clinical Operations functional and associated management staff dependent upon Client structure and services. - Coordinates and manages resourcing process including hiring, selection, and onboarding/offboarding of staff. - Leads, manages, and develops direct reports to improve efficiency and effectiveness at prioritizing work and to ensure performance meets or exceeds business and personal goals/objectives. - Facilitates, communicates, and addresses operational and/or performance issues including problem identification and resolution. - Hires, retains, and develops a skilled, experienced, and motivated team. - Minimizes regrettable turnover. - Provides technical support to team members and managers to ensure they have the required knowledge to fulfill duties. - Supports and promotes staff professional development; assesses and provides opportunities for soft skills development. - Conducts one-on-one meetings with direct reports, based on program requirements. - Observes, collects, analyzes, and communicates FSP Clinical Operations problems/issues, develops action plans or alternatives for resolution, and escalates as appropriate. - Conducts formal performance reviews. - Works with Senior Management in developing managers and ensures a talented pipeline of management staff within the department or function. - Oversees onboarding and training of staff, as applicable. - Reviews and approves content of curriculum vitaes (CVs), and conducts job description reviews for staff. - Oversees training compliance of staff related to SOPs, systems, and processes. - Collaboration - Collaborates with interdepartmental functions (e.g., Training, Quality, Contracts, Recruiting, Finance, Human Resources, etc.), as well as Client representatives, for initiatives and/or deliverables. - Supports execution of FSP Clinical Operations goals as required. - May serve as FSP Clinical Operations subject matter expert (SME) during audits and/or inspections. - Identifies and implements applicable process improvements as appropriate. - Participates in cross-industry initiatives/working groups which may include preparing and presenting at industry meetings, as applicable. - May serve as a working group member in SOP reviews or process related initiatives. - Collaborates with interdepartmental functions to create business proposals including Requests for Information/Requests for Proposal (RFIs/RFPs) to meet each Client's specifications. - General Operations and Functional/Business Unit Management - Participate in, champion or lead Parexel and department system/standards improvement activities or committees, task force groups as needed, including change management. - Maintain an agreed level of productivity/billability and staff turnover. - Complete routine administrative tasks in a timely manner (e.g. timesheets, training, travel expense claims). - Manage compliance with travel and billability guidelines for department, region or function, where appropriate. - Ensure client and business needs are met and that all projects are optimally resourced with suitably experienced staff. - Implement process improvements, in conjunction with Management team and Quality Management Group, in response to client and team feedback and quality audits. - Look within and beyond CRS to encourage teamwork, quality and productivity efforts to the benefit of CRS and Parexel. - May manage multiple countries, sub-region/s and/or subcontractors. - Follow up departmental metrics, drive team members to meet departmental goals. - Participate in departmental meetings and training initiatives, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary. - Implement process improvements, in conjunction with Senior Management and Quality, in response to Client and team feedback and/or audits. - Serves as a key communication liaison between FSP Operations Management and staff. - Regional Management - Establishes FSP Clinical Operations solutions for prospective, newly established, and existing Clients specializing in various outsourcing and insourcing models. - Works with Senior Leadership and FSP Sales to develop market positioning and key messaging. - Identifies potential opportunities for additional business with existing Clients. - Develops work orders/service orders for Client work and ensures continued maintenance for assigned Clients. - Manages Client-driven initiatives to standardize all phases of the clinical trials process, including the development of metrics to measure performance and enhance productivity and effectiveness. - Collaborates with applicable departments and appropriate Client personnel, on a strategic level, to ensure all operational aspects of contracted services meet time, quality, and cost targets. - Monitors contractual requirements are met and monitored on an ongoing basis. - Manages Client relationships. Skills - Exceptional interpersonal skills and communication skills, both written and verbal. - Demonstrated ability to effectively interact with all levels of management and other functions within an organization. - Demonstrated leadership in ensuring direct reports are communicating and coordinating efforts to provide superior services to the Client. - Strong ability to manage and motivate direct reports and wider team. - Ability to work across multiple and varied programs projects/tasks and prioritize workload effectively with attention to detail. - Well-developed planning, observation, analytical, and problem-solving skills. - Independent judgment and decision-making skills with respect to functional responsibilities. - Self-motivated, detail-oriented, and flexible. - Strong computer skills with MS-Office products such as Excel, Word, and PowerPoint. - Proficient in written and spoken English required. Knowledge and Experience - Minimum 5+ years of FSP Clinical Operations experience; and a minimum 3 years of previous line management experience. - Direct experience with Full Hybrid FSP Flex Model & Staff Augmentation Experience. - Direct experience with FSP Resourcing Projections, Billing & Financial Tracking. - In-depth knowledge of overall drug development process and clinical trial operations. - Knowledge of and demonstrated experience with application of regional talent acquisition, labor/working practices, retention strategies, and cultural differences. - Previous experience working in a remote office environment and independently managing remote staff. - Experience working in customer service/FSP outsourcing model. Education - Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or relevant clinical other equivalent experience. EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

• Supervise and lead clinical team members delivering services to a portfolio of customers • Interview, hire, onboard, and support the professional growth of team members, including regular 1:1s, team meetings, and performance reviews • Ensure high-quality, timely delivery of clinical services, including assessment, ongoing care management, crisis intervention and safety planning, care coordination and clinical training and presentations • Monitor team caseloads and key performance metrics, implementing benchmarks and workflows that drive performance and meet internal SLAs • Lead your team through rapid change and evolution as we evolve our approach to care to maximize impact for our customers and members • Ensure that timely and effective Critical Incident Response and Management Consultation is delivered as needed • Deliver case audit feedback and coaching, proving clinical consultation to ensure adherence to quality standards, clinical best practices, and documentation protocols • Support operational readiness for high-acuity or after-hours needs, including periodic on-call responsibilities and coordination with overnight teams • Collaborate with clinical leadership and cross-functional stakeholders to improve team processes, develop SOPs, and refine clinical models • Maintain a pulse on emerging needs across your programs and work proactively to ensure clinical excellence, compliance, and responsiveness • Foster a collaborative, mission-driven team culture that aligns with Spring Health’s values and commitment to removing every barrier to mental health

Role Description We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for an experienced Trial Master File TMF Lead II to help build the foundation of this new regional function in LATAM! Our TMF Lead II is responsible for supporting project teams in maintaining a high quality Trial Master Files in accordance with Good Clinical Practice (GCP), other guidance documents, and Precision Standard Operating Procedures (SOPs). The TMF Lead II supports a range of studies across the Precision Medicine Group portfolio. - Ensure that TMF document review and processing, periodic quality review, set up, maintenance, finalization and archival of study TMFs is completed in a timely manner and with a high level of quality. - Create and execute the study TMF Plan and project TMF Document Index. Ensure entire study team understands expectations, project-specific aspects of the TMF, and manage communication of any changes in the TMF Plan or Index to the project team. - Ensure that TMF documentation (e.g. TMF Plan, TMF Index, Periodic Quality Review documentation) is filed in the TMF. - Attend and contribute to project kick-off meetings, project internal or external meetings, and ad hoc meetings as needed to ensure the project team is aware of the status of the TMF, potential gaps and escalations. - Engage and collaborate with the Project Manager and Functional Leads to ensure TMF documentation is submitted in a timely manner and with high quality in order to maintain the TMF in an inspection-ready state. - Ensure that TMF Risks are identified and appropriately documented and mitigated. - Monitor and report on TMF Health and Metrics and escalate non-compliances and potential issues to internal team and Senior Leadership as required. - Identify trends, risks, and overall status of the TMF and suggest mitigation strategies. - Support Audits and Inspections and finding resolutions and participate in Audit/Inspection interviews with support and oversight from Line Management. - Ensure that Periodic Quality Review for assigned projects is initiated and performed by the Quality Review Specialists and ensure proper documentation. - Ensure that document review and processing for assigned projects is performed by the Document Specialists on a timely and consistent basis. - Identify project team TMF training needs and provide or support team re-education. - Manage the close-out activities of assigned studies, including defining the timeline for final document submission, final document processing, close out of all outstanding queries, requesting the eTMF export from the vendor, transfer to the sponsor and collect the Acknowledgement of Receipt. - Where needed, manage projects within the Sponsor eTMF System. - Monitor and report potential out of scope activities related to Records Management and communicate this to TMF manager for support. Qualifications - Bachelor’s degree (or its international equivalent). - A minimum of 3 years of related experience or equivalent combination of education, professional training and experience that provides the individual with the required knowledge, skills, and abilities to perform the job. - Professional working proficiency in English. Requirements - Established experience and fluency in the Microsoft Office package of programs (Outlook, Word, Excel and PowerPoint). - Experience with eTMF systems and vendors. - Working knowledge of FDA & ICH/GCP regulations and guidelines. - Demonstrates solid interpersonal skills. - Ability to identify issues and escalate appropriately and effectively. - Good organizational skills, time management, and ability to coordinate workload and meet established deadlines. - Demonstrates, or is able to be trained and retain a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance. - Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment. - Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, and maintain positive interactions with internal and external stakeholders. - Communicates both verbally and in written form in an efficient and professional manner. - Demonstrates values and a work ethic consistent with Precision Values and Company Principles. Company Description