This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Manager of Clinical Data Management oversees and manages all aspects of data management operations including staffing and resourcing, project management, budget, and operations management and client management. The manager applies a high level of technical expertise to effectively lead all data management. What You’ll Do: - Serve as study manager on clinical studies, as assigned, ensuring teams are delivering with quality, on time, and as per study budget. - Serve as People Manager for allocated staff. - Serve as subject matter expert during client and vendor meetings. - Actively support business development in capabilities presentations to prospective and current clients. - Effectively provide input for department and clinical study budgets. - Liaise with internal and external cross-functional teams, sponsors, vendors, etc. - Mentor data management staff. - Ensure project work is planned, resource allocated and is successfully executed. - Provide direction to staff when issues arise that the staff cannot resolve on their own. - Ensure proper training and development of staff, inclusive of creation or update of Standard Operating Procedures, Work Instructions, Forms and Templates. - Conduct regular meetings and complete year-end performance reviews with all direct reports. - Monitor performance of team and initiate process and resource improvement in partnership with Data Management leadership. - Participate in departmental initiatives, as available. - Adhere to all aspects of Ora’s quality system. - Comply with Ora’s data integrity & business ethics requirements. - Perform other related duties incidental to the work described herein. - Adherence to all essential systems and processes that are required at Ora to maintain compliance to business and regulatory requirements. - Clear and sustained demonstration of Ora’s values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors. - Responsibilities may differ from the above based on the specific needs of the business. Qualifications - Master’s degree (preferably in Engineering, Applied or Life Science) and at least five (5) years of experience in Clinical Data Management including leading several clinical studies, or a Bachelor’s degree (preferably in Engineering, Applied or Life Science) or equivalent education and work experience with a minimum of six (6) years of experience in clinical trials, or current Certified Clinical Data Manager (CCDM) status and six (6) years of experience in clinical trial. - Two (2) years of experience direct management of personnel is preferred. - Clinical research in a CRO setting and CDISC SDTM training is preferred. Requirements - Articulate and professional. - Extensive experience in Clinical research. - Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations. - Strong project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills. - Effective leadership, budget forecast and implementation skills. - EDC experience in multiple EDC systems including Medidata Rave preferred. - May Require Travel up to 10%. Benefits - Clear and Direct Communication, Feedback and Conflict Resolution. - Practice radical candor in your communication and participate in active giving and receiving feedback frequently. - Seek meaning and purpose and a desire to be part of something bigger than yourself.

This cross-functional role is responsible for the execution of Inotiv’s global health monitoring and biosecurity programs. You will work with international teams to ensure that Inotiv animals meet required health standards and exceed customer expectations. Key Accountabilities - Partner Collaborate with Inotiv’s health testing laboratory in Italy to manage and interpret the global health testing results for North America and European production locations - Review and Interpret health reports and escalate unexpected findings as appropriate - Develop and implement KPIs for health monitoring; track and trend performance - Collaborate with Operations to ensure health testing schedules and shipments are correct and on time; analyze process failures and make necessary improvements utilizing Quality tools - Track and analyze costs against budgets of routine health testing program as well as any third-party laboratory spend; provide monthly updates and explanations for any over or under budget spend - Use scientific knowledge to evaluate health and biosecurity problems - Appropriately utilize scientific literature and internal data to answer technical customer questions or complaints associated with health or biosecurity - Create and deliver internal and external scientific presentations which may include posters, abstracts, webinars and seminars for scientific industry meetings and trainings - Collaborate and assist the commercial marketing team in the development of internal and external content related to health monitoring for website and sales support to support marketing campaigns associated with animal care and health testing - Lead biosecurity projects and initiatives with a Quality mindset utilizing continuous improvement principles to facilitate change - Draft and update processes, procedures and documentation associated with health testing and biosecurity with an emphasis on continuous improvement - Ability to occasionally travel for training, scientific site meetings and customer support. Required Skills - Flexibility with the ability to work independently or as part of a cross-functional and multi-disciplinary team - Ability to analyze data, independently solve problems and know when to escalate to the next level Qualifications - Degree in biological sciences or related field with experience in laboratory animal health or similar field. - Bachelor’s with a min of 5 years’ experience - Master’s with a minimum of 3 years’ experience - Ph. D with a minimum of 2 years’ experience - Understanding of viral and bacterial impacts on laboratory animal health and how environmental biosecurity contributes to maintenance of health standards. - Must be located in the CT or EST time zone and be available occasionally during earlier hours for Global responsibilities Preferences - Working knowledge of Lean Six Sigma concepts including 5S, value stream mapping, data driven decisions, and visual management - Experience solving problems with Quality tools including DMAIC - Understanding of genetic factors that may impact animal health or breeding requirements - Experience in molecular biology, genotyping assay design and NGS are a plus - Working Conditions & Physical Requirements Remote with occasional office and operations site visits Critical Success Factors - Results Driven. Internal drive toward action to efficiently, timely, and accurately achieve results. Sets high but achievable standards for self and others. Seeks opportunities to improve process and outcomes. Constantly reviews performance to identify areas to develop. - Efficient. Takes responsibility for own time and effectiveness. Identifies what needs to be done and does it before being asked or before the situation requires it. Able to work things out without having to be shown too often. Seeks opportunities to contribute appropriately without direction. - Communication. Able to communicate information and ideas clearly and articulately both in oral and written form. Uses appropriate language, style and methods depending on audience and the purpose of communication. Able to convey complex information clearly. Anticipates the information that others will need. Expresses ideas effectively. Practices attentive and active listening. - Critical Thinking and Problem Solving. Able to identify and separate out the key components of problems and situations. Able to manipulate and interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this. Can generate a range of creative solutions, evaluate, and choose the most appropriate option - Improvement Driven. Inspires and generates new solutions and approaches to issues and challenges to maximize efficiency and effectiveness through everyday practice of root cause analysis and critical thinking problem solving; Continually works to refine skills and abilities; Builds on ideas of others to come up with new ways to address issues or problems; Generates creative new solutions and approaches to issues and processes. *This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person’s relevant experience and/or education level. Inotiv is a growing contemporary drug discovery and development company where we “Play to Win” in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There’s an opportunity for everyone at all phases of a career, each individual’s unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people’s lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world. Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more! Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine This is a remote role available in all states within the US. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. We are searching for the best talent for Portfolio Engagement Lead, Oncology, which can sit remotely within the United States. Purpose: The Portfolio Engagement Lead (PEL) role is responsible for fostering strategic and business partnerships with key institutions across J&J Innovative Medicine (J&J IM) Oncology clinical development programs and identifies new institutions to strategically partner with J&J IM. The PEL is accountable for shaping and driving unified and impactful institutional-level partnerships, agreements, and/or alliances, resulting in improved J&J IM operational predictability and site experience, and increasing site acceptance, enrollment and share of enrolled patients. Additionally, they are accountable for synthesizing site level intelligence, including a deep understanding how trials are performed throughout the ecosystem (e.g., review boards, timelines, IP processes), and the institutions’ evolving business needs, priorities and processes, to shape site-aligned strategies for J&J IM. Reporting to the Portfolio Engagement Leader, Oncology this role is an essential thought partner and influencer to key leadership roles across the J&J IM Oncology business, such as Oncology Delivery Unit, Disease Area Strongholds, Compound Development Team Leaders, Clinical Leaders, R&D Quality, and Medical Affairs (MAF). You will be responsible for: - Fosters a strategic and business partnership across all DASs with a given institution and identifies new institutions that could be strategic partners to J&J IM. - Understands local clinical trial market dynamics and analyzes and applies data to assess opportunities and priorities, including internal priorities, entity priorities, relevant marketplace trends and the competitive landscape. - Synthesizes site level intelligence to shape site-aligned strategies and efficiencies for J&J IM, including a deep understanding how trials are performed throughout the ecosystem (e.g., start-up requirements, review boards, timelines, IP processes, patient flow/referrals). - Based on site intelligence, recommend strategies that may reduce site burden, improve efficiencies, or increase enrollment potential. - Provides input to the company strategy for Investigator Engagement in partnership with the Patient Site & Engagement organization. Develops annual Strategic Account specific plans that include recommended attendees, agreed upon key objectives, strategies and tactics and records specific activities and results against identified objectives. - Champions institutional-level partnerships, agreements, and/or alliances. - Ensures J&J has the latest and deep understanding of the sites’ evolving business needs (e.g., changes in strategy) / changes in ways of working and organization (e.g., institutions’ clinical research models). - Facilitates/organizes cross-portfolio-level conversations with key operational and clinical stakeholders at institutions. - Address systemic issues/challenges at a given institution that may impact across the portfolio, e.g., facilitating the development of infrastructure for institutional-level contracting and agreements across trials and sites. - Responsible for the coordination across the organization to ensure the right J&J teams (e.g., clinical, legal, GCO, MAF, commercial) are informed of relevant information. - Facilitates institutional roundtables and gatherings to share best practices across sites and the various stakeholders involved in clinical trials. - Ensure compliance with healthcare regulations and internal standards in all HCP engagement activities. Principal Relationships: Internal: Oncology and MAF: DAS Delivery Leaders, Program Delivery Leaders, R&D Oncology TA Leadership, CDTs and Clinical Teams, US and Global MAF, GCO Country Heads, BGIA, Data Science, J&J IM Quality. External: Investigational sites, Key Opinion Leaders, Patient Engagement Groups, Advocacy groups, Vendors with a focus on study placement or recruiting and retention capabilities. Qualifications / Requirements: Education: Bachelors degree in a scientific or health-related discipline is required. Experience and Skills Required: - A minimum of 8 years of relevant experience required, with significant oncology drug development experience preferred. - Deep Understanding of Investigator and KOL engagement and how to optimize their experience. - Excellent written and oral communication skills; fluency in English language required. - Proven experience in influencing internal stakeholders and managing external partnerships. - Ability to comfortably communicate clinical trial designs and scientific data clearly and effectively with physicians and scientists. - Ability to understand and communicate market trends in healthcare related to the impact on the clinical trial delivery landscape across therapeutic areas. - Experience in developing innovative engagement strategies that are scalable and adaptable. - Independent thinker with an innovative mindset that can contribute new ideas for consideration. - Proven strong facilitation skills to run effective meetings that result in clear decisions and assigned next steps. Excellent presentation skills and ability to influence are required. - Proactive learner, seeks new information and appropriately assimilates into daily job responsibilities - Up to 50% domestic travel anticipated. Experience and Skills Preferred: - Healthcare qualification (e.g. Nursing, Pharmacist, Physician’s assistant) strongly preferred. - In depth understanding of Oncology drug development in the pharmaceutical industry, and the diverse ecosystem of the US healthcare and clinical trial system. - Well-organized, able to prioritize and orchestrate strategy to drive approaches to success. - Self-directed; able to work with limited supervision, and contribute to team objectives. #LI-Remote The expected base pay range for this position is $137,000.00 - 235,750. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: - Vacation –120 hours per calendar year - Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year - Holiday pay, including Floating Holidays –13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year - Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child - Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member - Caregiver Leave – 10 days - Volunteer Leave – 4 days - Military Spouse Time-Off – 80 hours Additional information can be found through the link below. For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. This job posting is anticipated to close on 2/26/2026. The Company may, however, extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Budgeting, Clinical Trial Designs, Clinical Trials, Compliance Management, Consulting, Contract Management, Execution Focus, Fact-Based Decision Making, Give Feedback, Industry Analysis, Laboratory Operations, Organizing, Process Improvements, Project Integration Management, Research and Development, Research Ethics, Technical Credibility

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: MedTech Sales Job Sub Function: Clinical Sales – Hospital/Hospital Systems (Commission) Job Category: Professional All Job Posting Locations: Phoenix, Arizona, United States, Santa Clara, California, United States of America Job Description: Job Description Johnson & Johnson is hiring for a Field Clinical Specialist for Shockwave Medical Inc. located in the Phoenix area. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Field Clinical Specialist is a visible position that will provide case support to physicians within certain territories. Case support will be done on peripheral and coronary interventional procedures in the pre-market and post-market phases of product development with the Shockwave Medical Intravascular Lithotripsy (IVL) ® technology. The Field Clinical Specialist will also play a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs. Case support may be required to support other territories at certain times. Essential Job Functions - Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices. - Effectively meet the needs of internal and external customers with a sense of urgency and drive. - Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, inclining study protocol, instructions for use, core lab manuals and case report forms. - Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders. - Partner with other clinical research colleagues to meet business needs in the field including site re-training, data collection for timely database locks and resolution of critical issues. - Administrative activities including training to procedures, manage territory travel and budgets. - Other duties as assigned. Qualifications - Minimum Bachelor’s Degree in business, science, nursing or related fields, or equivalent experience. - Minimum 2 years’ experience directly supporting interventional or surgical procedures within a hospital setting OR, 1 year of industry, hospital-based life sciences, sales support experience. Cardiovascular industry experience preferred but not required. - Working knowledge of clinical research, Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials. - A history of effective collaboration with regulatory agencies through clinical studies and market releases. - Product knowledge including product vigilance and medical device reporting. - High attention to detail and accuracy. - Computer skills (MS Office products, word processing, spreadsheets, etc.). - Finance and budgeting knowledge. - Good prioritization and organizational skills. - Excellent critical thinking skills. - Excellent influencing and negotiation skills. - High energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people. - Entrepreneurial “hands-on” experience. Pro-active and “can do” attitude. - Ability to consider and accept feedback and suggestions for continuous improvement. - Works effectively on cross-functional teams. Demonstrated willingness to make decisions and to take responsibility for such. - Effective written, verbal and presentation skills with all levels of customers and management. - Ability to work in a fast-paced environment while managing multiple priorities - Operate as a team and/or independently while demonstrating flexibility to changing requirements. - There may be continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) - Significant travel >50% of time requiring the employee to be effective in a remote manner. - Employee may be required to lift objects up to 40lbs or more. Employees will be required to work in an air conditioned office space and possibly perform some tasks in our non-temperature controlled warehouse space. Pay Transparency: Additional Information: - The base pay range for this position is $100,000. - The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan. - This position is eligible for a car allowance through the Company’s Fleet program - Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. - Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). - Employees are eligible for the following time off benefits: - Vacation – up to 120 hours per calendar year - Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year - Holiday pay, including Floating Holidays – up to 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year - Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Business Behavior, Communication, Consulting, Cross-Selling, Customer Centricity, Customer Effort Score, Customer Retentions, Execution Focus, Goal Attainment, Hospital Operations, Innovation, Market Research, Medicines and Device Development and Regulation, Sales, Solutions Selling, Sustainable Procurement, Vendor Selection