• Support cross-functional study execution teams to drive successful clinical trial delivery • Provide strategic guidance and oversight to study teams, proactively resolving operational challenges and risks • Manage study timelines, resources, and deliverables to ensure trials meet quality, cost, and schedule expectations • Oversee CROs and external vendors to ensure performance aligns with contractual and operational requirements • Support study feasibility, including patient enrollment strategies, site selection, and data collection planning • Contribute to protocol development and ensure study execution aligns with program objectives • Implement risk mitigation strategies to support successful trial outcomes

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description We’re looking for a TMF Specialist who takes pride in precision and understands that great clinical science depends on disciplined execution. You will own the organization, quality review, and integrity of essential trial documents within our electronic Trial Master File (eTMF) system. Your work ensures our studies stand up to regulatory scrutiny — and ultimately helps us deliver therapies to patients faster. - Review and quality check trial documents to ensure accuracy and compliance. - File and maintain essential records in the eTMF system. - Flag and track quality issues, ensuring they are resolved quickly. - Support filing and archiving across multiple clinical studies. - Work closely with TMF Operations Lead to update filing processes and guidelines. - Help manage periods of high document submission. Qualifications - Bachelor’s degree or equivalent - 2-4 years of experience in clinical trials, TMF, or related roles (Sponsor, CRO, or Site) - Knowledge of ICH-GCP, good documentation practices, and eTMF systems (e.g., Veeva) - Organized and detail oriented - Great communicator and team player Requirements The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Benefits - 99% of the premium paid for medical, dental and vision plans. - Company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. - Dollar-for-dollar match up to 6% on eligible 401(k) contributions. - Long-term stock incentives and ESPP. - Discretionary quarterly bonus. - Extremely flexible wellness benefit. - Generous PTO, paid holidays, and company-wide shutdowns. - A collaborative and inspiring work environment. - Annualized base salary compensation in the range of $75,000 — $93,000 USD. Company Description Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis, we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity, and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

Paradigm is an accountable specialty care management organization focused on improving the lives of people with complex injuries and diagnoses. The company has been a pioneer in value-based care since 1991 and has an exceptional track record of generating the very best outcomes for patients, payers, and providers. Deep clinical expertise is the foundation for every part of Paradigm’s business: risk-based clinical solutions, case management, specialty networks, home health, shared decision support, and payment integrity programs. We’re proud to be recognized—again! For the fourth year in a row, we’ve been certified by Great Place to Work®, and for the third consecutive year, we’ve earned a spot on Fortune's Best Workplaces in Health Care™ list. These honors reflect our unwavering commitment to fostering a positive, inclusive, and employee-centric culture where people thrive. Watch this short video for a brief introduction to Paradigm. The Clinical Coordinator (LPN or RN) plays a critical role in coordinating and managing medical and healthcare-related services for injured workers, partnering closely with patients, employers, providers, adjusters, and internal teams to support appropriate treatment plans and timely return-to-work outcomes. This role requires strong clinical judgment, organization, and communication skills, along with the ability to independently analyze medical information and collaborate across disciplines to drive quality, compliant case management. This is a full-time, fully remote position, offering the opportunity to make a meaningful impact while working from home. The schedule for this role is Monday through Friday, 11:00 AM – 7:30 PM Eastern Time. Ideal candidates bring a nursing background (LPN or RN), experience in workers’ compensation or related clinical settings, and a commitment to service excellence, ethical practice, and continuous improvement. Responsibilities: - Support the Mission, Values and Vision of Paradigm, promoting positive public relation and demonstrating service excellence, respect for customers, coworkers, and management. - Consistently maintain a high level of ethical and professional standards, continuously striving to improve healthcare services. - Provide appropriate follow up with supervisor, co-workers, case managers, and providers regarding updates, reported complaints and concerns. - Collaborate effectively with all departments through interdepartmental referrals and communication. - Support and participate in common teamwork to achieve departmental and organizational goals, cooperating and working together with team as well as other internal and external partners. - Actively participate in the QA process and departmental improvement efforts, identifying clinical areas for improvement - Plan and complete job duties, organizing individual caseload to meet jurisdictional and Best Practice Standards for timeliness, notification, and documentation requirements. - Independently approaches problem resolution by appropriate use of research and resources. Appropriately research, review, analyze and prepare medical information, document pertinent information in the case file notes, apply evidence based established guidelines to support case management interventions and facilitate the case management process, collaborating objectively with case managers, adjusters, and internal departments for case resolution. - Utilize appropriate desktop resources to perform the case management process. - Identify any concerns within the department and bring to the attention of the Clinical Nursing Supervisor and if needed, the Vice President of Operations. - Identify quality assurance and risk management issues and bring to the attention of the appropriate management. - Precept new staff within the department as requested. Assist with on-call duties on assigned weeknights or weekends and is compensated accordingly. - Maintain reliable and predictable attendance during scheduled work hours. Qualifications: - Education/Training: Current RN or LPN state licensure in good standing with the State Board of Nursing. - Experience: Previous Work Comp Case Management experience with at least three (3) years hospital/clinical experience in Orthopedics, Neurology, Occupational Health, Med/Surg or other comparable clinical discipline. - Knowledgeable of injured worker’s rights and ability to ensure an atmosphere which to promote the privacy, dignity, and well-being of injured workers. - Maintain confidentiality of all data, including injured workers’ Protected Health Information (PHI), employee, and operations data. - Skills: Excellent verbal and written communication, cooperation, service excellence, and effective conflict resolution skills; Able to promptly address concerns with tact and provide appropriate follow up; proficient reading, writing, grammar, and mathematics skills; strong knowledge of medical terminology; Excellent organizational, prioritization, and multi-tasking skills; Excellent computer skills (e.g., Outlook, Teams, to be trained on proprietary software). - Comply with all regulatory requirements, current laws and policies which protect workers from harassment and all illegal and discriminatory behavior. Comply with applicable Quality Assurance initiatives. - Complete requirements for required training, demonstrate acceptable attendance, and appropriate personal appearance. - Equipment/Machinery Used: Standard office equipment including phones, scanners, fax, laptop/PC, copiers, various computer programs, etc. Paradigm Benefits: - Health and wellness– We want our people to be and stay healthy, so we offer PPO, HDHP, and HMO health insurance options with Cigna and Kaiser (CA employees only). - Financial incentives – Paradigm’s financial benefits help prepare you for the future: competitive salaries, 401(k) matching contributions, employer-paid life and disability insurance, flexible spending and commuter accounts, and employer-matched HSA contributions. - Vacation - We believe strongly that work-life balance is good for you and for our company. Our paid time off and personal holiday programs give you the flexibility you need to live your life to the fullest. - Volunteer time– We want our employees to engage with and give back to their communities in meaningful ways. Full and part-time employees receive one paid day per calendar year. - Learning and development: One of Paradigm’s core values is expertise, so we encourage our employees to continually learn and grow. We support this in a variety of ways, including our new Learning Excellence at Paradigm (LEAP) program. Paradigm believes that fostering a diverse and inclusive workplace is central to our mission of helping more people and transforming lives. We’re striving to build a culture that better reflects the society we live in and empowers our team to deliver the highest levels of compassion and care to those we serve. For us, achieving this goal requires a workforce that respectfully embraces differences and commits to positive change, creating an environment where everyone is able to bring their whole self to work. Paradigm complies with federal and state disability laws and makes reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact Leave Management at leave.management@paradigmcorp.com. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. As a contractor with the State of Wisconsin, Paradigm complies with Wisconsin Contract Compliance Law (§16.765). Poster link: Contract Compliance Law Poster #LI-Remote

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Clinical Associate About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: - Career development with an international company where you can grow the career you dream of. - Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. - An excellent retirement savings plan with a high employer contribution - Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Our Abbott story is one of delivering bold solutions in the face of complex healthcare challenges. At Abbott Electrophysiology (EP), we’ve been a leader for over 20 years, pioneering one of the first mapping systems, introducing the first contact force ablation catheter and creating a portfolio of products trusted in millions of procedures around the world. We have and will continue to redefine what’s possible in an evolving and challenging EP landscape. When you join Abbott EP, you become part of a passionate group of individuals who are dedicated to driving the EP space forward and helping people live longer, fuller lives. We are committed to building a foundation for our people to be successful, investing in their development and growth, and creating a diverse, inclusive culture that welcomes different perspectives, experiences and backgrounds. What You’ll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. As a Clinical Associate on the U.S. Abbott EP team, you will provide clinical and technical support in a hospital setting, utilizing EP technology in the treatment of various cardiac arrhythmias. You will join a high-functioning, collaborative team, partnering closely with physicians and hospital staff to support the diagnosis and treatment of abnormal heart rhythms to achieve better patient outcomes. In this role, individuals will exercise independent judgment in planning, organizing, and performing day-to-day tasks. You will identify and routinely use the most effective, cost-efficient, and best business practices to execute processes, regularly communicating insights, feedback, and results to managers and team. Additional responsibilities include: - Gaining foundational knowledge of EP through a structured training program with a strong emphasis on hands-on learning and practical application. - Providing regional EP procedural case coverage in an Electrophysiology lab and/or operating room setting. - Acting as a clinical interface between the medical community and the business. - Demonstrating the ability to build and sustain credible clinical relationships with customers and sharing product expertise accordingly. - Demonstrating a thorough command of all EP products, including technical details, software utilization, and capabilities. - Providing engineering, sales, education, and clinical support on the safe and effective use of Abbott EP products, including cardiac mapping, diagnostic, and therapy systems. - Supporting EP Sales Representatives in the following areas: - Collaborating with sales personnel; - Facilitating regional training seminars; - Participating in clinical studies/data collection; - Troubleshooting; and, - Leading/supporting new product in-service trainings and/or demonstrations to physicians, nurses, and sales representatives. - Continuously develops engineering, sales and technical skills aligned with the overall territory strategy, including learning from senior sales personnel and management. - Staying up-to-date on the latest industry developments, regulatory requirements, and maintains strong knowledge of company and competitor products, market trends, and strategic goals. - Providing management with feedback on market trends and customer insights to inform strategic decisions and guide next-generation product development. - Participating in occasional travel for in-person instruction and live procedure coverage. Required Qualifications - Bachelors Degree or equivalent experience. - Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s). Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews. The base pay for this position is $50,700.00 – $101,300.00In specific locations, the pay range may vary from the range posted. JOB FAMILY: Support Services DIVISION: EP Electrophysiology LOCATION: United States of America : Remote ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 50 % of the Time MEDICAL SURVEILLANCE: Yes SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf