• Serve as lead biostatistician for programs of studies, submissions, or on simple to complex individual studies • Oversee statistical activities that support ICON’s interactions with clients and regulatory agencies • Review and approve statistical methods sections of study protocols, statistical analysis plans, and statistical input to reports • Program using SAS and/or R for inferential statistics • Prepare and approve research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients • Participate in bid defense meetings and make presentations at marketing meetings with prospective clients • Mentor or provide support to junior statisticians • Lead or partake in initiatives to improve internal processes or create new guidance

As a Clinical Trial Manager you will be responsible for leading the delivery of clinical study site management activities through the co-ordination of a team of Clinical staff within a geographic region. You will be responsible for ensuring site qualification, initiation, interim monitoring, site management and study close-out activities for studies in accordance with the with study protocol and study plan and Worldwide Standard Operating Procedures (SOPs). Ensures overall quality and timeliness of Clinical deliverables for assigned programs and/or region. Alternatively, may act as Report Reviewer.* Position Accountabilities/Responsibilities: _Tasks may include but are not limited to:_ Collaborate with Project Management to set site management targets/monitoring strategy and ensure compliance with project goals and Worldwide processes Provide leadership and direction to clinical site management team members from study start through to closure Serve as Site Management (SM) primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to: Primary SM Sponsor contact Investigator and Bid Defense Meeting Internal and External study team calls Project specific Audits / Inspections Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities Customize study-specific SM Quality Management Documents, e.g. the Clinical Monitoring Plans (CMP) Oversee compliance to the CMP, including site visits, outstanding trip reports and visit follow up letters Review protocol deviations and visit action items to ensure that activities are conducted according to the CMP. Provide CRAs training all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as needed Participate in the development and implementation of patient recruitment strategy in countries and sites assigned. Lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on target Drive efforts to improve the quality of site data and address any identified needs with action plans. Review data metrics to ensure data integrity and quality Track/measure SM deliverables to identify trends. Provide and monitor regular analytics through various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as needed Oversee TMF (Trial Management File) compliance of site management documents, ensuring that QC review is on target and TMF is inspection ready Formulate regional monitoring strategy and accountable for forecasting of site visits with CRA team in line with CMP to ensure staffing needs are met and any identified backlog is appropriately addressed Review/finalize trip reports according to Worldwide SOPs and expectations May perform site qualification, initiation, interim monitoring, and/or close out site visits as needed Provide a key role in problem solving and first line issue escalation regarding monitoring and site issues, providing proposed solutions to the project management team and sponsor as needed Proactively identify and mitigate risks May represent site management as primary contact on projects Conduct co-visits where required to ensure quality of site, the CRA work and study procedures. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Other Skills and Abilities: Excellent interpersonal, oral and written communication skills in English Excellent planning and organizational skills with effective time management Excellent presentation skills Flexibility to change Ability to manage multiple and varied tasks with enthusiasm Ability to negotiate and influence with diplomacy in order to achieve results Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified Must be able to prioritize tasks with attention to detail, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision Ability to lead and motivate a team remotely Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities Strong customer focus, ability to interact professionally within a sponsor contact Extensive understanding of clinical research principles and process Strong understanding of FDA and /or EU Directive regulations, ICH Guidelines and local regulatory requirements Experience in the study therapeutic indication/area Thorough understanding of standard operating procedures Proficient knowledge of Microsoft Office, eCRF, IVRS packages Proficiency with IxRS, CTMS and EDC systems Requirements/Qualifications: Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies and a minimum experience of three years as a Senior Clinical Research Associate (or equivalent), OR Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of five years as a Senior Clinical Research Associate, OR Minimum 6-month experience functioning as CTM/LCRA (or equivalent); supporting main CTM and coordinating clinical operations activities Travel required Valid current passport required Driving license required Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. *Note the Clinical Trial Manager role may also be referred to as a Lead Clinical Research Associate (LCRA)* Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.

Role Description This position is accountable for the direct management of assigned monitoring/site management related clinical trial staff across all clinical trial types, which may include pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional). - Accountable for the identification, onboarding, training and development of monitoring clinical trial talent. - Provides leadership/mentorship in a matrix setting for activities that support clinical trial teams. - Accountable to the Head, Early or Late Stage Site Monitoring & Management. - Provides input into departmental budget and resourcing strategies. - Develops and implements global processes and procedures. - Coaches monitoring staff during execution of development trials. Responsibilities - Responsible for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff. - Manages and allocates monitoring resources to trials and monitors performance on assigned trials for monitoring staff (up to 12 direct reports). - Provides direction, leadership and learning opportunities to enhance individual development of direct reports. - Provides oversight and guidance in completing monitoring and site management related activities according to agreed timelines and quality standards. - Oversees adherence to timelines, standards, processes for work assigned to their staff. - Serves as a point of escalation for clinical monitoring/site management related topics or issues from their staff. - Oversees and provides guidance to Clinical Operations Leads and/or Clinical Trial Leads in regional Key Opinion Leader (KOL) interactions. - Responsible for compliance of direct reports with training and identification and support for any training needs. - Facilitates and supports global trial monitoring operational standards and tools. - Anticipates, recognizes and facilitates problem solving to support site monitoring & management staff. - Collaborates effectively with portfolio operations Leads, clinical operations leads, Center of Excellence and PECs leadership. - Identifies, escalates, and facilitates process improvements relevant to clinical trial monitoring and site management. - Contributes to development and implementation of best in class monitoring/site management standards and processes. Qualifications - BA/BS degree with at least 8 years of executing global drug development programs and trials. - Minimum of 4 years site monitoring and direct people management experience. - Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations. - Extensive expertise in risk based monitoring strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial regulations. - Experience working across multiple phases of development and in multiple therapeutic areas. - Demonstrated ability to successfully identify and lead global process or system improvement initiatives. - Strong knowledge of clinical development processes and conducting global clinical programs. - Proven leadership skills and effective written and verbal communication skills. - Fluent in English. Depending on hiring region, may also be required to be fluent in local language. - Moderate (~30%) travel required. Preferred Qualifications - Advanced Degree. Location and Working Environment - Remote work from anywhere in the US is available. - Hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. Benefits - Medical, Dental and Vision Insurance. - Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down. - 401(k) match and annual company contribution. - Company paid life insurance. - Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions. - Long Term Incentive Plan for eligible positions. - Company fleet vehicle for eligible positions. - Referral bonus program. Salary Range $144,060 - 205,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

We welcome you to apply if interested! You will be asked to create an account, which takes less than one minute and requires only a username and password. The entire application takes no more than 5-7 minutes to complete. Our MedTech RN Clinical Educator’s experiences a unique opportunity to employ their clinical nursing expertise in a new way outside patient care, while continuing to collaborate with healthcare professionals and advocate for the well-being of patients through medical device technology. You will be responsible for training and educating Registered Nurses on medical devices primarily used for vascular access and blood collection. What you will be doing in the role: - Your primary focus will be in-servicing and education only; no sales responsibilities, and no bedside care. - Provide peer-to-peer education and in-servicing to nurses, and hospital staff to support medical device implementations - Assess customer-specific education needs and collaborate with staff to deliver a positive educational experience - Utilize clinical nursing expertise to answer questions and address concerns with the medical device - Provide updates, reports, and valuable feedback to client during and after in-service assignments - Training for this role will be provided and is paid. You will have an opportunity to travel, grow, and expand into new opportunities while earning supplemental income and learning the medical device industry. Job Requirements: - RN Degree - Associates required, Bachelor's preferred - Active and Unrestricted RN license required - Vascular Access experience of at least 3-5 years required - Excellent communication skills - Must be comfortable with basic software programs - Ability to clear hospital vendor credentialing requirements. Travel Requirement: - Minimum availability of 2 weeks per month required. - Travel regionally and nationally to support customer needs. - Driving is considered a business requirement for this role. Candidates must possess a valid driver’s license and will be subject to a review of their driving record prior to hire. - Located within 1 hour of a major airport. - Travel, and your time traveling is paid. Preferred Attributes: - ER, Critical Care unit experience of at least 2 years is preferred - Leadership experience (manager, educator, preceptor) can be helpful but is not required - Excellent documentation skills - Ability to work independently in customer settings with minimal supervision. IQVIA MedTech CFS takes the approach to helping customers drive healthcare forward in this challenging and fast-paced environment. We help customers accelerate results, improve patient outcomes, and unleash new opportunities. Benefits: This position is not eligible for our benefits. Vaccine/Immunization/Hospital Credentialing Requirement: A required function of this job requires individuals to enter various healthcare facilities.  Thus, upon selection, individuals must complete healthcare facility credentialing process.  To obtain credentials, individuals must meet the immunization requirements specified by the facility.  Individuals are typically required to have completed/up to date: Measles, Mumps & Rubella vaccine, Varicella (chicken pox) vaccine, Negative Tuberculosis (TB) Test, Tetanus, Diphtheria & Pertussis (Tdap) vaccine, Hepatitis B vaccine, Influenza vaccine (seasonal), and COVID-19 vaccine primary series (heavily enforced by most facilities, some require booster(s)). Please note, IQVIA complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons, however, our client’s requirements may supersede this. *Please note: Due to the nature of this role, it is not eligible for Visa sponsorship. IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status RN1 #LI-CES #LI-DNP IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role is 38-45 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.