Role Description As part of our CDS Dermatology team, you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Trial Master File Associate is responsible for organizing, maintaining, and overseeing the Trial Master File (TMF) according to company policies, SOPs, Work Instructions, regulatory requirements, TMF Functional Lead, and PM delegation. - Notify study team that TMF is created and ready for document upload for eTMF or submission to pTMF. - Develop TMF Plan. - Provide training on study specific TMF requirements, guidelines including TMF Plan. - Perform QC2 on documents and documents reconciliation. - Provide TMF Monthly Reports to PM, Line manager, and Head of TMF Delivery. - Regularly check TMF metrics, follow up on detected issues, ensure acceptable level of metrics. - Ensure TMF processes timely implementation and execution. - Adjust study specific TMF Index/EDL in the relevant files/system as directed by the PM. - Ensure valid forms and templates are implemented and maintained in the assigned projects. - Check status of duplicates, documents in error, size and path length (if applicable), follow up on necessary corrections accordingly. - Coordinate Monthly and Quarterly TMF Reconciliation by creating Action Plan and submitting relevant report on the status. - Ensure TMF AoR completion and monitoring TMF transfer/shipment to the Sponsor. - Ensure delivery of fully executed TMF AoR to TMF Functional lead. - Actively follow up that the study team is submitting documentation, EDL maintenance for eTMF in cooperation with study team, following the process described in The TMF Plan and that the TMF is always submission and inspection ready. Qualifications - At least 1-5 years of experience in CRO or Pharmaceutical Industry with proven TMF Management. - Bachelor’s Degree in Health Science or Document Management or equivalent work experience is preferred. - Knowledge of GCP/ICH guidelines. - Good written and communication skills. - Good organizational and multi-tasking skills. - Good software and computer skills. - Able to work in a fast-paced environment with changing priorities. Benefits - Competitive compensation package. - Comprehensive benefits. - Opportunity for personal and professional growth in a rewarding environment. - Join a team that values collaboration, innovation, and making a difference in the lives of patients.

Title: Clinical Design & Evaluation Manager Location: United States Remote Job Description: Maven is the world's largest virtual clinic for women and families on a mission to make healthcare work for all of us. Maven's award-winning digital programs provide clinical, emotional, and financial support all in one platform, spanning fertility & family building, maternity & newborn care, parenting & pediatrics, and menopause & midlife. More than 2,000 employers and health plans trust Maven's end-to-end platform to improve clinical outcomes, reduce healthcare costs, and provide equity in benefits programs. Recognized for innovation and industry leadership, Maven has been named to the Time 100 Most Influential Companies, CNBC Disruptor 50, Fast Company Most Innovative Companies, and FORTUNE Best Places to Work. Founded in 2014 by CEO Kate Ryder, Maven has raised more than $425 million in funding from top healthcare and technology investors including General Catalyst, Sequoia, Dragoneer Investment Group, Oak HC/FT, StepStone Group, Icon Ventures, and Lux Capital. To learn more about Maven, visit us at mavenclinic.com. An award-winning culture working towards an important mission – Maven Clinic is a recipient of over 30 workplace and innovation awards, including: - Fortune Change the World (2024) - CNBC Disruptor 50 List (2022, 2023, 2024) - Fortune Best Workplaces for Millennials (2024) - Fortune Best Workplaces in Health Care (2024) - TIME 100 Most Influential Companies (2023) - Fast Company Most Innovative Companies (2020, 2023) - Built In Best Places to Work (2023) - Fortune Best Workplaces NY (2020, 2021, 2022, 2023, 2024) - Great Place to Work certified (2020, 2021, 2022, 2023, 2024) - Fast Company Best Workplaces for Innovators (2022) - Built In LGBTQIA+ Advocacy Award (2022) Maven is looking for an enthusiastic and collaborative Clinical Design & Evaluation Manager to help us analyze how Maven’s world-class support for women and families impacts clinical outcomes (e.g., preterm birth, mental health, conception) and to collaborate cross-functionally with Maven’s Product team to develop care models & interventions. The Clinical Design & Evaluation Manager will collaborate closely with all members of the Clinical team, as well as the Data team, Product team, and Care delivery/provider teams. The role will be focused on mining both self-reported, HIE, and platform data to answer questions about Maven’s clinical impact and on crafting materials to communicate these with the scientific community and clients (e.g., white papers, scientific publications, powerpoint slides). In this role, you will also work closely with the Product team to support evidence informed product design and evaluation. This includes reviewing clinical guidelines and literature to size and prioritize highest impact interventions as well as translating evidence into care workflows within the Maven product. You will communicate clinical outcomes to the scientific community and Maven’s Growth team, and inform clinical product strategy and design in order to continuously drive better clinical outcomes in our product. As a member of our AI-forward team, you will leverage AI to increase efficiency and quality of Maven’s research, as appropriate. As a Clinical Design & Evaluation Manager at Maven, you will: - Help design retrospective and prospective projects to evaluate Maven’s impact on health outcomes - Collaborate with the Clinical and Product teams on analyses and literature reviews to inform clinical strategy, care workflows and product design - Quantitatively analyze data for projects assessing Maven’s influence on health outcomes using statistical analysis software (R preferred) - Communicate research results and design strategy to a diverse audience including the scientific community, clients, and internal cross-functional teams - Collaborate with the Marketing team on analyses to support market campaigns - Work closely with Maven’s Directors, Clinical Research on research analyses and publications We’re looking for you to bring: - Minimum of a master’s degree and 3 years work experience or a PhD in healthcare, public health, or a related field and industry exposure - Experience developing clinical protocols, care pathways, and decision logic that translate evidence into scalable program structures - Coding experience, in SQL and R (or with the desire and ability to learn R quickly if in another language), and a passion for dissecting and reconstructing complex issues with a data-driven approach - Statistical experience with adjusted regressions and structural equation modeling - A profile that balances technical abilities to answer questions through data manipulation and strong written and verbal communication skills, including “translation” with team members of varying technical abilities and clinical subject matter expertise - A sense of flexibility and prioritization in juggling both long-term, strategic projects and ad hoc, urgent requests as needed in a fast-paced startup environment - Ability to learn fast. No specific content expertise is required but you will be expected to quickly learn about a range of health topics and conditions. - Passion to drive better maternal and family health outcomes, and help grow new and innovative care models in women’s and family health Helpful experiences and skills (if you don’t have them, you can learn them with us!): - Experience with data visualization software (Looker a plus) - Experience working with Product teams and/or a start-up environment - Experience using AI tools in a professional or research context — such as enterprise coding assistants, AI-powered workflows, or agentic tools — to meaningfully accelerate analysis, writing, or synthesis tasks The base salary range for this role is $119,000 - $161,000 per year. You will also be entitled to receive equity and benefits. Individual pay decisions are based on a number of factors, including qualifications for the role, experience level, and skillset. This role requires active work authorization in the US. Maven embraces a flexible hybrid work model. Our teams primarily operate from the New York Metropolitan area, NY, and remotely via San Francisco/Bay Area, CA, Seattle, WA, Boston, MA, Chicago, IL, and Washington, D.C. For those in our New York City office, we encourage in-person collaboration by requiring team members to work onsite three days a week (Tuesday, Wednesday, Thursday). For those based in San Francisco/Bay Area, CA, Seattle, WA, Boston, MA, Chicago, IL, and Washington, D.C., we encourage in-person collaboration by requiring team members to attend quarterly Work Together Days within these cities. This policy aims to balance remote work flexibility with the benefits of face-to-face interaction. At Maven we believe that a diverse set of backgrounds and experiences enrich our teams and allow us to achieve above and beyond our goals. If you do not have experience in all of the areas detailed above, we hope that you will share your unique background with us in your application and how it can be additive to our teams. Benefits That Work For You Our benefits are designed to support your health, well-being and career development, helping you thrive both personally and professionally. We remain focused on providing a competitive benefits package for our employees. On top of standards such as employer-covered health, dental, and insurance plan options, we offer an inclusive approach to benefits: - Maven for Mavens: access to the full platform and specialists, including care for mental health, reproductive health, family planning and pediatrics. - Whole-self care through wellness partnerships - Hybrid work, in office meals, and work together days - 16 weeks 100% paid parental leave and new parent stipend (for Mavens who've been with us for 1 year+) - Annual professional development stipend and access to a personal career coach through Maven for Mavens - 401K matching for US-based employees, with immediate vesting These benefits are applicable to Maven Clinic Co., US-based, full-time employees only. 1099/Contract Providers are ineligible for these benefits. Maven is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, national origin, veteran status, or genetic information. Maven is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. Maven Clinic interview requests and job offers only originate from an @mavenclinic.com email address. Maven Clinic will never ask for sensitive information to be delivered over email or phone. If you receive a scam issue or a security issue involving Maven Clinic please notify us

• 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.