Mavericks Wanted When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on   In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.    Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. Job Summary The Clinical Trial Master File (TMF) Specialist is responsible for the ongoing maintenance, quality control, and oversight of the Trial Master File to ensure inspection readiness and compliance with applicable regulatory requirements (e.g., ICH-GCP, FDA, EMA). This role supports clinical trial teams by managing TMF documents throughout the study lifecycle and ensuring timely, accurate, and complete filing. Key Responsibilities TMF Management & Maintenance - Maintain the electronic Trial Master File (eTMF) in accordance with ICH-GCP, regulatory requirements, and internal SOPs - Ensure timely collection, processing, indexing, and filing of essential documents - Perform ongoing TMF quality control (QC) checks for completeness, accuracy, currency, and consistency - Track missing, incomplete, or late documents and follow up with internal teams, CROs, vendors, and sites Quality & Compliance - Conduct periodic TMF health checks and reconcile TMF content against expected document lists - Support TMF review cycles, audits, and inspection readiness activities - Identify TMF risks, trends, and gaps; propose and implement corrective actions - Ensure documents meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) Cross-Functional Collaboration - Serve as a TMF subject matter expert for study teams, CROs, and functional partners - Support TMF-related training for internal staff and external partners - Participate in study startup, maintenance, and close-out activities from a TMF perspective Process Improvement & Reporting - Generate TMF metrics, dashboards, and status reports - Contribute to TMF process improvements, SOP updates, and inspection readiness initiatives - Support implementation or optimization of eTMF systems and workflows Required Qualifications - Bachelor’s degree in life sciences, health sciences, or a related field (or equivalent experience) - 2–5+ years of experience in clinical trials, TMF management, or clinical operations - Strong working knowledge of ICH-GCP and global regulatory requirements - Experience with eTMF systems (e.g., Veeva Vault eTMF, Wingspan, MasterControl, TMF Reference Model) - Excellent attention to detail and document quality standards At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. Salary $115,000—$145,000 USD As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. For USA based roles: Financial & Rewards - Market-leading compensation - 401(k) with employer match - Employee Stock Purchase Program (ESPP) - Pre-tax commuter benefits (transit and parking) - Referral bonus for hired candidates - Subsidized lunch and parking on in-office days Health & Well-Being - 100% employer-paid medical, dental, and vision premiums for you and your dependents - Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA) - Fertility & family-forming benefits - Expanded mental health support (therapy and coaching resources) - Hybrid work model with flexibility - Flexible, “take-what-you-need” paid time off and company-paid holidays - Comprehensive paid medical and parental leave to care for yourself and your family Skill Development & Career Paths: - People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility - We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching - We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Are you motivated to participate in a dynamic, multi-tasking environment? Do you want to become part of a company that invests in its employees? Are you seeking a position where you can use your skills while continuing to be challenged and learn? Then we encourage you to dive deeper into this opportunity. NeoGenomics is looking for a Clinical Cytogeneticist who wants to continue to learn in order to allow our company to grow. This is a full time, remote position. Now that you know what we're looking for in talent, let us tell you why you'd want to work at NeoGenomics: As an employer, we promise to provide you with a purpose driven mission in which you have the opportunity to save lives by improving patient care through the exceptional work you perform. Together, we will become the world's leading cancer reference laboratory. Position Summary: As a Cytogeneticists you are responsible for clinical consultation to the clinical laboratory within her/his area(s) of expertise which will maximize quality patient care and ensure continuous business growth throughout the Laboratories. Performs all necessary tasks involved in the processing of patient samples, with accuracy and efficiency, essential to render a diagnosis and/or prognosis of acquired and inherited cytogenetic and or molecular genetic oncology disorders/diseases. Experience & Required Qualifications: - Requires a Ph.D., DO or MD - Four or more years of Clinical Lab experience as a Director in assigned specialty. Must meet all licensing as required by CLIA or Director accreditation from a national certifying agency. - State: FL Director’s License, CA Director/Scientist License, and NY Certificate of Qualification in Cytogenetics and National: American Board of Medical Genetics (ABMG) Board Certified in Clinical Cytogenetics or Laboratory Genetics & Genomics OR in Clinical Pathology by the American Board of Pathology. - Must possess excellent communications skills, both written and verbal, and be fluent in English. Must be able to express opinions clearly and concisely. - Must be able to deal tactfully with clients and co-workers. - Must demonstrate professionalism, maturity, and alignment with the company’s mission and principles. - Must demonstrate an awareness of, and sensitivity to, cultural differences both with internal staff and external clients. - Must be a motivated, energetic, self-starter with a progressive and flexible work style. - Must be a strategic thinker who takes an innovative and proactive approach to defining problems and identifying and implementing solutions. - Must be willing and able to embrace, drive, and manage organizational change - Ability to work independently and within a team environment - Must be able to work in a fast paced, multi-tasking environment and maintain production and quality standards

Global Study Lead ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Global Study Lead to join our diverse and dynamic team. As the Global Study Lead, you will hold a crucial role in ensuring the successful delivery of all clinical aspects of the studies. Your expertise and leadership will be instrumental in managing the clinical portion of the budget, developing effective monitoring plans, and driving enrollment to meet project objectives. Moreover, you will liaise with stakeholders, identify and mitigate risks, and provide comprehensive reporting on all clinical activities. What you will be doing: - Budget Oversight Oversee the clinical portion of the budget to ensure efficient resource allocation. - Ensuring Effective Study Oversight: Develop monitoring plans and tools, ensuring effective study oversight. - Optimizing Performance: Train and mentor Clinical Research Associates (CRAs) to optimize their performance. - Timely Study Start-Up & Enrollment: Drive enrollment and lead study start-up activities, adhering to timelines. - Improving Study Integrity Review trip reports and implement corrective and preventative action plans when necessary. Building Productive Relationships: Foster productive relationships with Sponsors, vendors, and cross-functional teams. Your profile: - A minimum of 4+ years of experience in a Clinical Trial Management position at a CRO or Pharmaceutical Organization. - Bachelor's degree in health, life sciences, or other relevant fields of study. - At least 10+ years of relevant experience in clinical trial management. - Preferred: 2+ years of monitoring experience. - Experience in managing complex or global trials is advantageous. - Preferred: Experience in managing all trial components from start-up to database lock. - Preferred: Experience in coaching/mentoring other CTMs, leading a team of CTMs, and participating in departmental initiatives. - Fluency in English (reading, writing, speaking). What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Job Details Senior Regulatory Research Coordinator (Sidney Kimmel Cancer Center - Remote Position) Job Description Job Summary: The Sidney Kimmel Comprehensive Cancer Center (SKCCC) Clinical Trials Office (CTO) is seeking a Senior Regulatory Research Coordinator dedicated to supporting a complex portfolio of investigator-initiated trials. The Senior Regulatory Research Coordinator works under limited supervision and is responsible for the accurate compilation and submission of protocols and related study documents to various internal and external approving committees. These may include the Protocol Review and Monitoring Committee (PRMC), IBC, Radiation Safety, FDA and/or NIH, and the applicable Institutional Review Board (IRB). The Senior Regulatory Research Coordinator is responsible for maintaining electronic regulatory study files to ensure all protocols and essential regulatory documents are current and complete. Primary Responsibilities: Serves as the primary regulatory contact for assigned protocols. - Maintains the electronic regulatory binders / files and ensures appropriate version control is in place. - Coordinates submissions to ancillary committees such as Radiation Safety and Institutional Biosafety. - Communicates with the IRB and sponsor on behalf of the study team regarding regulatory management. - Collaborates with the study team and sponsors to finalize documents based on PRMC and/or IRB recommendations. - Prepares and submits study amendments and continuing review applications for PRMC and IRB review. - Prepares regulatory files for auditing and monitoring visits. - Communicating to study teams the importance of adhering to CTO Regulatory processes - Other duties as assigned Qualifications: The ideal candidate will have a HS diploma with 6 years clinical research experience and SOCRA Certification, or a Bachelor’s degree in a scientific or healthcare-related field with at least 2 years clinical research experience, or a Master’s degree in a scientific or healthcare-related field with 1 year clinical research experience. Additional qualifications include: - Strong written and oral communication skills, attention to detail, customer service orientation, and proven ability to perform work accurately and efficiently. - Experience working with grant funded and Investigator-Initiated clinical trials. - Knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials. - Familiarity with terminology and processes associated with the conduct of clinical research. - Experience with clinical trial management systems, such as OnCore and ClinicalTrials.gov. - Demonstrated ability to work independently and with a team. - Demonstrated proficiency with Microsoft Office, including Outlook, Teams, OneNote, Word, and Excel. Work Shift Rotating (United States of America) Worker Sub Type Regular Employee Entity Thomas Jefferson UniversityPrimary Location Address 1025 Walnut Street, Philadelphia, Pennsylvania, United States of America Nationally ranked, Jefferson, which is principally located in the greater Philadelphia region, Lehigh Valley and Northeastern Pennsylvania and southern New Jersey, is reimagining health care and higher education to create unparalleled value. Jefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students. Jefferson Health, nationally ranked as one of the top 15 not-for-profit health care systems in the country and the largest provider in the Philadelphia and Lehigh Valley areas, serves patients through millions of encounters each year at 32 hospitals campuses and more than 700 outpatient and urgent care locations throughout the region. Jefferson Health Plans is a not-for-profit managed health care organization providing a broad range of health coverage options in Pennsylvania and New Jersey for more than 35 years. Jefferson is committed to providing equal educa­tional and employment opportunities for all persons without regard to age, race, color, religion, creed, sexual orientation, gender, gender identity, marital status, pregnancy, national origin, ancestry, citizenship, military status, veteran status, handicap or disability or any other protected group or status. Benefits Jefferson offers a comprehensive package of benefits for full-time and part-time colleagues, including medical (including prescription), supplemental insurance, dental, vision, life and AD&D insurance, short- and long-term disability, flexible spending accounts, retirement plans, tuition assistance, as well as voluntary benefits, which provide colleagues with access to group rates on insurance and discounts. Colleagues have access to tuition discounts at Thomas Jefferson University after one year of full time service or two years of part time service. All colleagues, including those who work less than part-time (including per diem colleagues, adjunct faculty, and Jeff Temps), have access to medical (including prescription) insurance. For more benefits information, please click here