Role Description Veranex has an exciting opportunity to join our team as a Clinical Research Associate II to support our Clinical Operations team. The CRA II will participate in the planning, development, and execution of clinical trials to evaluate the safety, effectiveness and performance of medical devices. Under management supervision, the CRA II will monitor assigned clinical trials to ensure adherence to the clinical protocol, applicable regulations, and company Standard Operating Procedures (SOPs) governing clinical studies. Location: Remote, US What You Will Do: - Ensure that study investigators and coordinators comply with the study protocol, Good Clinical Practices (GCPs), Code of Federal Regulations (CFRs), and Institutional Review Board (IRB)/Ethics Committee (EC) requirements during clinical studies by training/guidance of investigators/research coordinators, conducting periodic on-site evaluations and follow-up of corrective actions. - Act as primary liaison to clinical sites. - Conduct site qualification visits, study start-up activities (essential document collection), site initiation visits and training, monitoring visits for source data verification, and site close-out visits. - Generate high-quality site qualification, initiation, monitoring, and close-out visit reports in a timely manner (in accordance with the Clinical Monitoring Plan). - Contribute to protocol, informed consent, case report form (CRF) and study plan development as well as annual progress reports (APRs) and the clinical study report (CSR) at study conclusion to report the study results to FDA and other regulatory authorities. - Ensure that the rights and well-being of human subjects are protected and confirm data quality/integrity by maintaining site compliance, reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary. - Support maintenance of department SOPs and work instructions. - Support investigational device traceability including documentation for forecasting, shipping, receipt, and disposition. - Support and maintain documentation of all clinical research activities in the study trial master file (TMF), e.g., monitoring reports, site correspondence, device inventory information. - Coordinate trial enrollment and identify and communicate potential and actual obstacles to enrollment. - Travel requirement: 25-50%. Qualifications - 2-4 years of directly related work experience or equivalent in clinical research, including work on medical device significant risk IDE trials and/or non-significant risk abbreviated IDE trials. - Must be able to work autonomously and as a member of a cross-functional team and meet high expectations and tight deadlines. - Must have working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB requirements. - Must have strong project management competencies and ability to work with high quality, reliability, and attention to detail. - Must have a strong level of professionalism, including verbal and written communication skills; and the ability to communicate with all levels of the organization, cross-functionally, and with clients/partners. - Must have proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint; as well as experience with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems. - Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments. - Familiarity with medical and anatomical terminology. - Ability and willingness to travel. Preferred - BS or BA degree preferred; BS or BA in a relevant scientific discipline or related field also preferred. Company Description Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.

Associate Director of Real World Evidence (Pharma Co Experience Required) - Remote US Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities - This role is open to US employees with no sponsorship needs - Skillset: AD Epi PharmaCo Epi, writing protocols, working with analysts, Trouble shoot code lists, CPRD. - PharmaCo experience required Developed and executed under Scientific Oversight study protocols, analysis plans, and study reports to answer research questions of priority to RWE - Designed and managed epidemiological, biomarker and/or data science projects - Planned, designed, and conducted analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries) - Supported the identification of fit-for-purpose data for the timely execution of the RWE strategy - Constructed cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed - Conducted analyses for descriptive and comparative research using RWD (examples include claims, EHR, PRO/COA, registry data) for methodologic research questions - Contributed to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers - Supported the effective communication of study/analysis results to support internal and external decisions - Coauthored abstracts and manuscripts for external dissemination of methodologic study results - Contributed to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities - Technical Expertise o Observational research methods (both Primary and Secondary Data Collection), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes - Project Implementation o Protocol writing, SAP, manuscript and abstract writing At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $114,000.00 - $210,900.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Design and conduct epidemiological studies to generate real-world evidence within time, budget, and quality standards, including but not limited to: natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies

Role Description Join the team leading the next evolution of virtual care. At Teladoc Health, you are empowered to bring your true self to work while helping millions of people live their healthiest lives. Here you will be part of a high-performance culture where colleagues embrace challenges, drive transformative solutions, and create opportunities for growth. Together, we’re transforming how better health happens. The Director, Clinical Research and Evaluation leads Teladoc Health’s clinical research agenda, focused on generating high-quality, publishable evidence from real-world data and prospective studies. This role helps strengthen our scientific reputation and ensures research insights are used to guide product development, care model improvement, and strategic decisions in virtual care. With a high degree of ownership, the Director, Clinical Research and Evaluation identifies key evidence needs, shapes study designs, partners with analytics on approach and interpretation, and leads dissemination through peer-reviewed publications and scientific presentations. The role also represents Teladoc Health with academic, regulatory, and scientific stakeholders, and works closely with executive and clinical leaders to translate findings into clear, decision-ready recommendations. Qualifications - Ph.D., Sc.D., DrPH, or equivalent doctoral degree in biostatistics, epidemiology, health services research, public health, health economics or related quantitative discipline. Or, MPH or MS in related disciplines and 5+ years of experience. - Advanced expertise in statistical modeling and quantitative research methodologies with an emphasis on quasi-experimental designs and causal inference. - Demonstrated experience collaborating with commercial and client stakeholders to develop, interpret, and present clinical research findings. - Demonstrated experience analyzing large, complex healthcare datasets (claims, EHR, digital health, remote monitoring). - Experience in the design and implementation of RCTs and prospective studies with strong understanding of regulatory compliance. - Expertise in SQL, R, and Python. - Strong written and verbal communication skills with demonstrated experience translating complex analytics to diverse audiences. - Exemplary cross-functional collaboration skills with clinicians, quality and safety professionals, clinical researchers, data scientists, and commercial colleagues. - Demonstrated experience in clinical research, with several peer-reviewed publications as first and senior author. - Exceptional oral and written communication skills, with the ability to present complex clinical concepts and health outcomes data to non-clinical stakeholders. - Proficiency with virtual care platforms and digital health technologies. - Ability to thrive in a highly dynamic, fast-paced environment, balancing multiple competing priorities. Requirements - Experience designing and conducting implementation science studies (e.g., implementation evaluation, adoption, and sustainment). - Experience in designing and conducting formal quality improvement studies for publication with emphasis on quality improvement analytics and methods such as statistical process control (SPC) and planned experimentation / factorial design. - Track record of grant writing or securing research funding. - Established network within academic medicine or digital health research communities. - Familiarity with national quality frameworks and measurement standards (e.g., HEDIS, NCQA, CMS quality programs). - Passion for advancing data-driven, evidence-based virtual care. Benefits - The base salary range for this position is $160,000 - $190,000. - This position is eligible for a performance bonus and benefits (subject to eligibility requirements). - We follow a Flexible Vacation Policy, intended for rest, relaxation, and personal time. - All time off must be approved by your manager prior to use. - You will also receive 80 hours of Paid Sick, Safe, and Caregiver Leave annually.

Role Description Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). - Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters. - Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. - Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. - Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. - Participates and presents in key meetings such as Kick Off Meeting. - Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. - Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones. - Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. - Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team. - Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. - Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct. - Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project. - Reviews the project oversight dashboards and other clinical trial systems to oversee site and patient activities. - Understands the monitoring strategy required for the study and participates in the development of the study risk assessment plan. - Reviews the content and quality of site and central monitoring documentation to ensure they represent site management activities and conduct. - Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities. - Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. - Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance. - Provides feedback to line managers on staff performance including strengths as well as areas for development. - May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects. - May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation. Qualifications - Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience. - Demonstrated ability to lead and align teams in the achievement of project milestones. - Demonstrated capability of working in an international environment. - Demonstrated expertise in site management and monitoring (clinical or central). - Preferred experience with risk-based monitoring. - Demonstrates understanding of clinical trial management financial principles and budget management. - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements. - Must demonstrate good computer skills. - Strong conflict resolution skills. - Demonstrated ability to apply problem solving techniques to resolve complex issues. - Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues. - Moderate travel may be required, approximately 20%. Benefits - We are passionate about developing our people, through career development and progression. - Supportive and engaged line management. - Technical and therapeutic area training. - Peer recognition and total rewards program. - Committed to building an inclusive culture – where you can authentically be yourself. - Driven to Deliver – capturing the passion of our colleagues to shape solutions that impact lives. - Continuously building the company we all want to work for and our customers want to work with.