Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as Associate Clinical Data Team Lead – Make an Impact at the Forefront of Innovation We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Associate Clinical Data Team Lead, you will act as the assistant lead data manager for one or more projects, supporting the lead data manager by performing assigned tasks in study setup, data cleaning, database close-out, and other associated tasks. What You’ll Do: • Applies relevant components of the project protocol to daily tasks with guidance. • Delivers study specific training to junior associates for assigned projects. • Coordinates data cleaning tasks and delegates to appropriate data management staff to ensure quality standards are maintained and project deliverable timelines are met with minimal supervision. • Assists with specified activities that contribute to the creation of database specifications, database build and user acceptance testing during database and edit check development. • Monitors for risks to deadlines and escalates appropriately. • Creates and maintains data management project documentation. • Participates in team and client meetings and supports the lead data manager with risk management on allocated projects. • Provides input into project forecasting of hours and identification of resource requirements. • Monitors study metrics and runs project-specific status reports for management. • Reviews data management deliverables for allocated projects following documented guidelines. • Produces project-specific status reports for management, PM and/or clients on a regular basis Education and Experience Requirements: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: • Good written/ verbal communication skills with a strong command of English language and grammar; good organizational, analytical/problem solving skills and attention to detail • Ability to apply knowledge and skills in a highly organized fashion while adhering to regulatory guidelines, SOPs and client expectations • Ability to work productively with support and minimal supervision • Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data • Strong customer focus and excellent interpersonal skills • Proven flexibility and adaptability • Ability to work in a team environment and independently as needed • Ability to train and direct junior team members • Ability to set and meet timelines or be able to recognize and schedule changes in response to project demands Working Conditions and Environment: • Work is performed in an office environment with exposure to electrical office equipment. • Occasional drives to site locations • Occasional travel both domestic and international. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs.

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