Role Description This role supports the day-to-day operations of the IRB Office and provides excellent customer service to the research community, IRB committee members, and IRB Office staff in the course of daily functions. It serves as an information conduit between the IRB Office, IRB committee members, and investigators, sharing information and supporting the submission of materials as requested. This role assists the Clinical/Research Program Manager I (CPRMI - IRB) and Resource Coordinator III/IV/V (RC3/4/5) in coordinating seminars, scheduling meetings, making travel arrangements, and otherwise providing broad support for the IRB committee members, IRB office staff, and investigators in carrying out their research program. It also assists in providing guidance and training to the Resource Coordinator I (RCI) and supports the IRB electronic management system (eIRB) functionality, improvements, and maintenance. What you will do - Provide support to IRB Committees and IRB Office Staff and Leadership under the direction of the CRPMI-IRB and/or RC3/4/5 by: - Coordinating IRB meetings, including attendance, conference rooms, catering, technical support, and additional logistical issues. - Supporting general office needs, including answering phones, managing supplies, and scheduling meetings. - Maintaining and ensuring retention of all required IRB records and documents. - Assisting with the development and maintenance of the IRB Front Office manual. - Training and providing guidance to Resource Coordinator I (RCI) staff members. - Conducting administrative reviews of IRB submissions. - Updating and maintaining the IRB website. - Providing support for Accreditation of Human Research Protections Programs (AAHRPP) and FDA site visits. - Participating in relevant institutional research educational activities. - Preparing presentations, letters, reports, and related materials. - Performing other duties and assisting on special projects as assigned. - Provide support to investigators under the direction of the CRPMI-IRB and/or RC3/4/5 by: - Responding to emails, messages, and phone calls in a timely fashion. - Scheduling and attending meetings with investigators as needed. - Creating and developing messages, including website content and other formats. - eIRB System Maintenance & Training: - Providing support for eIRB system, including logging and identifying IRB issues. - Managing communications between the IRB office and the research community concerning changes to eIRB. - Assisting study team members with eIRB and the IRB submission process. - Providing on-demand education and training on the use of eIRB. - Assisting CRPMI - IRB with development and maintenance of eIRB job aids. - Manage and Collaborate on Related Responsibilities under the direction of the CRPMI-IRB and/or RC3/4/5 by: - Developing and maintaining contacts among peers within different departments. - Supporting IRB activities with other CHOP Divisions and Departments. - Responding to inquiries regarding IRB SOPs and functions. - Helping to support audits/site visits to manage risk. - Managing and tracking IRB member appointment letters. - Managing and tracking IRB committee member and staff HRPP training. - Assisting with training RCI and providing guidance as needed. Qualifications - High School Diploma / GED - Required - Bachelor's Degree - Preferred Requirements - At least three (3) years of research, coordination or administrative experience - Required - At least five (5) years of research, coordination or administrative experience - Preferred - At least three (3) years of experience in a healthcare related environment - Preferred - At least two (2) years of IRB, research administration, clinical research, human subject protection, regulatory compliance, or research experience - Preferred Skills and Abilities - Basic knowledge of medical terminology and protocols - Required proficiency - Basic knowledge of HIPAA regulations - Required proficiency - Intermediate proficiency with electronic medical record software (EPIC) - Required proficiency - Advanced proficiency with word processing software (Word) - Required proficiency - Intermediate proficiency with presentation software (PowerPoint) - Required proficiency - Intermediate proficiency with spreadsheet software (Excel) - Required proficiency - Excellent verbal and written communications skills - Required proficiency - Excellent customer service skills - Required proficiency - Excellent interpersonal skills - Required proficiency - Strong time management skills - Required proficiency - Strong organizational skills - Required proficiency - Solid conflict resolution skills - Required proficiency - Ability to work independently with minimal supervision - Required proficiency - Ability to maintain confidentiality and professionalism - Required proficiency - Ability to collaborate with stakeholders at all levels - Required proficiency Benefits - Salary Range: $24.87 - $31.09 Hourly - Factors such as skills and experience could result in an offer above the salary range noted in this job posting.

Title: Research Associate III - Real-World Science, Epidemiology & Scientific Affairs – Pregnancy Studies Location: Remote Massachusetts United States of America Full time Remote   The Real-World Science, Epidemiology and Scientific Affairs team focuses on generating real-world evidence and supports biopharmaceutical companies throughout the product lifecycle, from early pre-launch planning to launch and post-marketing management. Our focus is on helping our clients in the pharmaceutical/ biotechnology/ medical device industries generate real-world evidence to demonstrate and support the value of their products. Through the generation of real-world data via the design, implementation, and analyses of observational/non-interventional studies, we may provide key information such as:  - Incidence and prevalence of diseases and co-morbidities, and their risk factors - Burden of disease, unmet needs - Treatment patterns and drug utilization - Healthcare resource utilization - Overall safety, incidence of adverse events of special interest - Effectiveness and comparative effectiveness data - Pregnancy safety studies (e.g., pregnancy exposure registries, descriptive pregnancy safety studies)   This position will focus on supporting pregnancy safety studies.   Position Overview: The Research Associate III drafts project deliverables, interacts with clients, and contributes to strategic thinking under the direction of senior staff. The Research Associate III also supports scientific coordination and project management.   Essential Duties and Responsibilities (other duties may be assigned): The Research Associate III will bear scientific responsibility for the development of scientific deliverables (e.g., protocols, reports) that accurately summarize the study design of de novo data collection projects (retrospective, prospective, and/or cross-sectional) under oversight of more senior staff. The primary focus of this position will be to support pregnancy studies (e.g., pregnancy registries, descriptive pregnancy safety studies).   In particular, the Research Associate III will: - Participate in scientific guidance/consultation on scientific methodological and operational considerations of project design and conduct - Lead on or oversee development of project deliverables (e.g., protocols, case report forms (electronic or paper), survey questions, reports) for senior review. - Interact directly with project sponsors, physician experts, and clinical sites, if appropriate and under the guidance of senior staff - Assist the responsible scientist with monitoring project budget spend and managing timelines for scientific tasks/deliverables.  - Participate in the development of abstracts and manuscripts - Contribute to the growth of Prospective Real-World Studies through business development activities, including support of proposal development, participation in the sales cycle, and, when appropriate, presentations  - Support other organizational activities as needed (e.g., supervise and/or mentor junior staff, closely collaborate with other project stakeholders such as clinical operations, data management, biostatistics, and data analysts; contribute to development of training materials and process improvements) - Travel (national and international travel) may be expected Consulting Expectations: - Participates in client calls and is expected to be able to address questions posed directly to him/her about his/her work - Contributes to strategic thinking under the direction of senior staff.   Education, Professional Skills & Experience: - PhD (epidemiology or closely related field) or MSc with 1-5 years of relevant experience; advanced degree in perinatal epidemiology or equivalent training and/or experience in pregnancy highly desirable  - Experience with de novo data collection (field) projects (non-interventional designs in particular) is highly desirable - Good understanding of epidemiologic methodology - Previous experience in consultancy and/or CRO environment highly desirable - Working knowledge of MS Office software; working knowledge of data analysis software (e.g., SAS, Stata, R) a plus - Experience with design of peri- or post-approval late phase interventional projects is not required but would be considered a plus   Personal Skills & Competencies: - Demonstrated ability to communicate and document information effectively in written English, including the ability to produce scientific reports, presentations, emails and other written deliverables that are well-organized, free from errors, and are appropriately adjusted to the characteristics and needs of the audience. - Strong organizational, time-management, prioritization and decision-making skills necessary to evaluate, plan and accomplish multiple work goals in a timely fashion. - Able to quickly learn and apply new information, skills and procedures. - Proactive and positive approach to tasks and projects, as well as resilience when encountering process, project, budget or client changes that are inherent in the consulting environment. - Strong communication and interpersonal skills including the ability to quickly develop and sustain positive rapport with internal and external contacts in person, over the phone and by email. - Experience presenting ideas to individuals and groups in a formal presentation setting - Delivers a positive internal/external client experience; listens and understand the client's needs, and recommends solutions  - Demonstrates sound professional judgment in analyzing, responding to, and resolving enquiries, issues and escalations.  Compensation and Benefits The salary range estimated for this position based in Massachusetts is $105,000.00–$115,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: - A choice of national medical and dental plans, and a national vision plan, including health incentive programs - Employee assistance and family support programs, including commuter benefits and tuition reimbursement - At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy - Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan - Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

Role Description The Head of Research Delivery is a senior, client-facing leader responsible for delivering high-quality research programs and leading research teams across projects and accounts. This role owns and actively drives how research delivery operates in practice, including the systems, workflows, and team structures that enable successful execution. - Accountable for delivery performance across projects (on time, on budget, on value). - Improves how work flows across teams, reducing unnecessary handoffs. - Ensures projects are set up for success from the start. - Plays a critical role in enabling scale by simplifying how we work and increasing visibility across teams. - Ensures delivery models support growth without adding complexity or requiring proportional increases in effort. Qualifications - 10+ years’ experience in healthcare/biopharma market research or a related field. - Strong understanding of end-to-end research delivery, including project setup, execution, and cross-functional coordination. - Proven ability to manage complexity across multiple projects, teams, or portfolios. - Experience improving workflows, resourcing models, or operational processes to increase efficiency and scalability. - Strong organizational and problem-solving skills, with the ability to operate effectively across multiple stakeholders. - Clear, structured communicator with the ability to drive alignment and clarity across teams. - Comfortable operating in a fast-paced, evolving environment with changing priorities. - Demonstrated ability to balance delivery performance with team sustainability and workload management. Requirements - Senior oversight on key client accounts, ensuring delivery is aligned to client expectations. - Direct line management of a team of researchers, with responsibility for performance, development, and team effectiveness. - Staffing and resource allocation across all research projects and programs. - Capacity planning and workload visibility across teams and regions. - Design and optimization of end-to-end delivery workflows. - Reduction of operational complexity, including unnecessary coordination and duplicated effort. - Implementation and consistent application of standardized ways of working. - Alignment of delivery processes with Sales, Operations, and Innovation. Benefits - Establish clear ownership, roles, and responsibilities across projects. - Create visibility into team capacity and workload. - Foster a culture of accountability around delivery discipline. - Provide direct leadership and line management to team members. - Build a strong delivery-focused team culture. - Maintain accountability for delivery across projects. - Identify and address systemic delivery issues. - Support alignment between delivery approach and client needs. - Reduce operational complexity by simplifying workflows. - Ensure standardized ways of working are applied consistently. - Design and evolve delivery models that support growth. Company Description Not provided.

Role Description At Mindera, we build high-performance software products in close collaboration with our clients, focusing on engineering excellence, autonomy, and continuous improvement. We are looking for a Software Development Engineer in Test (SDET) to join a team working on a large-scale e-commerce platform. Expected travelling time (UK and USA): 0%-15%, varies according to project/client. You will be working with teams across different time zones and locations. What you’ll be doing: - Design, develop and maintain scalable test automation frameworks for mobile applications - Build and execute automated functional, integration, regression and end-to-end tests - Work with Appium, XCUITest, and Espresso to ensure robust mobile test coverage - Use WireMock to simulate services and support reliable integration testing - Implement Snapshot Testing strategies for UI regression validation - Contribute to quality engineering practices across the SDLC, promoting shift-left and continuous testing approaches - Integrate automated tests into CI/CD pipelines and support release quality gates - Collaborate closely with developers, product and engineering teams to ensure quality is built into the product from the start - Leverage Co-Pilot + CLI tools to improve productivity, automation and engineering workflows - Contribute to continuous improvement of testing practices, tooling and overall engineering excellence Qualifications - Solid experience in test automation engineering, particularly in mobile environments - Strong programming skills in languages such as Java, Kotlin, Swift or JavaScript - Experience building maintainable and scalable automation frameworks - Strong understanding of API testing and service virtualization - Experience working in Agile delivery teams and DevOps environments - Quality-first mindset with strong problem-solving and collaboration skills Benefits - Health Insurance, because health comes first - Flexible working hours - Open holidays, take the time you need for yourself - Profit distribution for everyone - Mindera Annual Trip, Sports, and sharing groups to connect and have fun! - Training & conferences, create your own training plan - Child Care vouchers - Choose Laptop & Peripherals that best suit your needs - Hotspot with unlimited usage (PT), for work or Netflix ;) - Amazing offices in Porto, Aveiro, and Coimbra for physical connection with minders - Remote from Portugal is also an option; remote from other countries will depend on your current location and projects - Wide range of snacks at the offices to keep you fed and healthy - Partnerships with local businesses - Work with a great team in a politics-free environment - Encouragement to take risks, make decisions, and enhance communication - Freedom and Responsibility go hand in hand, valuing commitment, feedback, and empathy Company Description At Mindera we use technology to build products we are proud of, with people we love. - Software Engineering Applications, including Web and Mobile, are at the core of what we do at Mindera. - We partner with our clients to understand their products and deliver high-performance, resilient and scalable software systems that create an impact in their users and businesses across the world. - Our culture reflects our lean and self-management attitude. - We encourage our colleagues to take risks, make decisions, work collaboratively, and enhance communication. - We are proud of our work and love to learn while navigating through an Agile, Lean, and collaborative environment. - Our offices are located in Porto, Portugal | Aveiro, Portugal | Coimbra, Portugal | Leicester, UK | San Diego, USA | San Francisco, USA | Chennai, India | Bengaluru, India | Cluj-Napoca, Romania.