• Foster and maintain favorable clinical site and investigator relationships. Including conducting and/or supporting informational calls for sites and investigators. • Support in planning and conducting investigator meetings, if applicable. • Review and/or approve of IP release packages. • Review monitoring reports for compliance to study protocols, regulations and ICH/GCP. Track and manage monitoring report metrics. If applicable, serve as a backup monitor to the monitoring team. • Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plans and communicates issues to Director and CRAs as appropriate. • Ensure accurate reporting of Protocol Deviations and follows up with monitoring team of any subsequent re-SDV and close out of PDs if applicable. • Provides any assistance with findings from Protocol Deviation Review Team meetings and disseminates any applicable information to the CRA team. • Conducts monitoring meetings, creating agendas and meeting minutes which may include but is not limited to: monitoring team training and tracking, report quality issues, site level issues/trends in data and EDC metrics reporting. • Assist in coordinating study specific training or re-training for the internal study team, internal monitoring team and site staff as appropriate. • Responsible for the ongoing development and maintenance of Trial Master File and Investigator Site Files in Veeva Vault which includes quarterly eTMF reviews. Assists CRAs in ensuring eTMF completeness, eTMF audit findings and resolutions. • Manages and/or supports vendor management for central laboratory, central IRB, central imaging, patient concierge services, and site payment systems including but not limited to: portal access management for sites and internal teams, report review, sample tracking, metrics review, document reviews and meeting participation • Facilitate EDC and IRT access requests for site teams. • Facilitate CRA team access to internal Ascendis systems such as TMF, EDC and vendor systems (e.g. IRT). • Assist and manage CRA transition meetings which may include creating and/or reviewing transition documentation • Run Study Team Meetings including providing agendas and meeting minutes. • Reviews site information/informed consents and completes associated checklists as per Ascendis SOPs. • Support central and site IRB/IEC and regulatory submissions, as needed. • Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits • Maintains CTMS including but not limited to: site and site staff contact information, study level and site level milestones, regulatory submissions and approvals on both study and site level. • Escalate pertinent CRA performance and site compliance issues when necessary. • Collaborate with Director of Clinical Operations, data management and CRAs to ensure data quality and compliance with data cleaning timelines. • Assist CRAs and sites with supply shipment/tracking, sample tracking and IMP shipment tracking and management. • May review and approve Vendor Data Clarification Forms. • Prioritize and escalate issues, as needed. • May develop or assist in developing study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials). • May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with Associate Director. • May be responsible for development, review and/or implementation of vendor documentation. • May perform clinical data review of patient profiles, data listings and summary tables, including query generation • May meet with Associate Director, Clinical Operations on a regular basis to report deliverables, timelines and employee development.

Title: Principal Clinical Research Associate Location: Sparks, MD, United States Job ID R-544580 Category Medical / Clinical Affairs Job Description: As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters' innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters' passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description Responsibilities Study & Site Management - Serve as Lead CRA for assigned complex clinical studies, providing expert oversight of site selection, initiation, monitoring, and close‑out activities (on‑site, virtual, remote, and in‑house). - Actively participate in site feasibility assessments and site selection processes. - Ensure study conduct is executed according to the clinical protocol (CPSP), regulatory requirements (GCP, FDA, ISO), IRB/EC requirements, and company SOPs. - Prioritize patient safety, ensuring informed consent and study procedures are performed accurately and ethically. - Review and report AEs/SAEs and protocol deviations in accordance with regulatory and company requirements. - Maintain complete, accurate, and audit‑ready regulatory documentation and TMFs in accordance with ALCOA principles. - Monitor site inventory of investigational products and study supplies. - Proactively identify, communicate, and manage study risks and issues to ensure operational continuity and compliance. Monitoring & Documentation - Author, review, and approve Monitoring Plans, study source documents, monitoring tools, and site‑facing training materials. - Perform SDR/SDV per monitoring plans and document monitoring activities through timely, high‑quality trip reports. - Ensure strict compliance with company travel and expense policies. Leadership & Mentorship - Provide mentoring, training, and functional oversight of CRAs, including contingent (contract) CRAs. - Lead or review functional job aids and training materials. - Support interviewing, hiring, onboarding, and training of CRA staff. - Manage and oversee day‑to‑day activities of contingent CRAs, including approval of timecards and expense reports. - Present confidently and contribute to extended functional and study team meetings, providing clear updates on site status, risks, and issues. Systems & Collaboration - Utilize and maintain accurate study data in clinical systems, including Veeva Vault CTMS and CDMS. - Work cross‑functionally with internal teams, CROs, and SMOs to ensure high‑quality study execution and oversight. - Build and maintain effective working relationships with investigator sites and internal stakeholders. Qualifications Education - Bachelor's degree or higher in a healthcare or science‑related field. - Alternate education levels may be considered based on experience and business need. Experience - Minimum of five (5) years of field‑based CRA experience in the medical device and/or pharmaceutical industry. - Experience across multiple phases of clinical research and product development. - Experience with IVD and/or POC studies strongly preferred. - Laboratory experience in molecular biology, microbiology, or blood culture is highly desirable. Knowledge & Skills - Strong understanding of clinical trial operations, monitoring practices, investigational product management, and data management. - Thorough knowledge of domestic and international clinical research regulations, including ICH GCP, FDA CFR, ISO, and HIPAA. - Proficiency with Veeva Vault CTMS and CDMS required. - Excellent written and verbal English communication skills, including medical terminology. - Strong presentation, organizational, time‑management, and prioritization skills. - Technically savvy with the ability to leverage technology to drive efficiency and performance. - Ability to work independently with minimal supervision in a fast‑paced environment. Why Join Us? To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills Primary Work Location USA MD - Sparks - 7 Loveton Circle Additional Locations Work Shift NA (United States of America) At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Title: Experienced Clinical Research Associate - Full-Service Location: Morrisville, NC, United States Job Description: Experienced Clinical Research Associate - Full-Service 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 - Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. - Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. - Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. - May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. - Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. - Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: - Bachelor's degree or RN in a related field or equivalent combination of education, training and experience - Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements - Must demonstrate good computer skills and be able to embrace new technologies - Excellent communication, presentation and interpersonal skills - Ability to manage required travel of up to 75% on a regular basis - US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. 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: $70,100.00 - $126,100.00 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. 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 Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.

Role Description The Sr. Clinical Trial Manager (Sr CTM) is responsible for effective conduct of Ascendis’ global and regional clinical trials. As a key member of the cross-functional team driving one or more Ascendis’ clinical trials to completion according to agreed timelines and quality, the Sr. CTM contributes directly to Ascendis’ focus on making a meaningful difference in patients’ lives and is part of a global organization with locations in US, Germany and Denmark. The role will be based in Palo Alto, CA or be remote and reports to the Director, Clinical Operations. Key Responsibilities - Foster and maintain favorable clinical site and investigator relationships, including conducting and/or supporting informational calls for sites and investigators. - Support in planning and conducting investigator meetings, if applicable. - Review and/or approve of IP release packages. - Review monitoring reports for compliance to study protocols, regulations and ICH/GCP; track and manage monitoring report metrics; serve as a backup monitor to the monitoring team if applicable. - Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plans and communicate issues to Director and CRAs as appropriate. - Ensure accurate reporting of Protocol Deviations and follow up with monitoring team on any subsequent re-SDV and close out of PDs if applicable. - Provide assistance with findings from Protocol Deviation Review Team meetings and disseminate applicable information to the CRA team. - Conduct monitoring meetings, creating agendas and meeting minutes which may include monitoring team training and tracking, report quality issues, site level issues/trends in data and EDC metrics reporting. - Assist in coordinating study specific training or re-training for the internal study team, internal monitoring team and site staff as appropriate. - Responsible for the ongoing development and maintenance of Trial Master File and Investigator Site Files in Veeva Vault, including quarterly eTMF reviews; assist CRAs in ensuring eTMF completeness, eTMF audit findings and resolutions. - Manage and/or support vendor management for central laboratory, central IRB, central imaging, patient concierge services, and site payment systems. - Facilitate EDC and IRT access requests for site teams. - Facilitate CRA team access to internal Ascendis systems such as TMF, EDC and vendor systems (e.g. IRT). - Assist and manage CRA transition meetings, including creating and/or reviewing transition documentation. - Run Study Team Meetings including providing agendas and meeting minutes. - Review site information/informed consents and complete associated checklists as per Ascendis SOPs. - Support central and site IRB/IEC and regulatory submissions, as needed. - Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits. - Maintain CTMS including site and site staff contact information, study level and site level milestones, regulatory submissions and approvals on both study and site level. - Escalate pertinent CRA performance and site compliance issues when necessary. - Collaborate with Director of Clinical Operations, data management and CRAs to ensure data quality and compliance with data cleaning timelines. - Assist CRAs and sites with supply shipment/tracking, sample tracking and IMP shipment tracking and management. - May review and approve Vendor Data Clarification Forms. - Prioritize and escalate issues, as needed. - May develop or assist in developing study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials). - May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with Associate Director. - May be responsible for development, review and/or implementation of vendor documentation. - May perform clinical data review of patient profiles, data listings and summary tables, including query generation. - May meet with Associate Director, Clinical Operations on a regular basis to report deliverables, timelines and employee development. Qualifications - Bachelor’s degree or master’s degree in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent). - Demonstrates mastery knowledge of ICH-GCP, relevant Ascendis SOPs and Work Instructions and regulatory guidance, as well as the ability to implement. - Working knowledge of clinical management techniques and tools. - Direct work experience in a cross-functional environment. - 7+ years of combined experience in managing/monitoring Phase 1, 2, or 3 clinical trials. - High proficiency in English with strong communication and presentation skills. - Experience managing and overseeing vendors. - Experience in performing clinical site monitoring visits, including remote visits. - Ability to prioritize and to work independently on assigned tasks, manage timelines, and to present ideas to sites/stakeholders clearly and effectively. - High proficiency with Veeva Systems (Clinical Vault eTMF, Veeva EDC), CTMS, Endpoint IRT and Microsoft Office (Outlook, Word, Excel, PowerPoint). - Possibility to travel up to 20% of the time domestically for investigator meetings, meetings with remote employees, co-monitoring, if needed. Benefits - 401(k) plan with company match. - Medical, dental, and vision plans. - Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance. - Company-provided short and long-term disability benefits. - Unique offerings of Pet Insurance and Legal Insurance. - Employee Assistance Program. - Employee Discounts. - Professional Development. - Health Saving Account (HSA). - Flexible Spending Accounts. - Various incentive compensation plans. - Accident, Critical Illness, and Hospital Indemnity Insurance. - Mental Health resources. - Paid leave benefits for new parents.