case manager

assistant clinical research coordinator - limited Jobs in Irvine

case manager - onsite

clinical research associate Jobs in Irvine

clinical research associate

clinical workflow coordinator - hybrid Jobs in Irvine

clinical workflow coordinator - hybrid

manager clinical affairs case review board

JenaValve Technology, Inc.

<div><div><div><b>Job Title</b>: Manager, Clinical Affairs (Case Review Board)</div></div><p>
</p><div><div><b>Role Level: </b>Individual Contributor
</div></div><p></p><div><div><b>Manager Title:</b> Senior Director, Clinical Affairs</div></div><p>
</p><div><div><b>Job Location &amp; Environment:</b> Irvine, CA, Corporate Office
</div></div><p></p><div><div><b>Job Description Summary: </b>Reporting to the Senior Director of Clinical Affairs, the Manager, Clinical Affairs (CRB) will be responsible for case planning for global clinical trials and collaborating with internal and external stakeholders (Field Clinical Specialists, Research Coordinators at investigational sites, imaging core laboratories, and Case Review Board) on CRB process development, execution, and improvement. This position provides leadership junior members of Clinical Affairs and support to multidisciplinary project teams, both internally and externally.</div></div><p>
</p><div><div><b>Job Responsibilities:
</b></div></div><ul><li><div>Drive scheduling and executing CRB meetings with committee members and site-level health care providers across all clinical trials.</div></li><li><div>
Oversee the training/coordinating of subject presentation materials for CRB meetings with clinical trial sites.</div></li><li><div>
Collaborate with cross functional team leaders to ensure harmonization of processes and practices for case planning efficiency</div></li><li><div>
Preparation and review of presentation materials for CRB meetings for all clinical trials with site clinical research coordinators, implanters, and field clinical specialists.</div></li><li><div>
Communication with clinical research coordinators and investigators on case approvals, scheduling, lab work, and excluded cases.</div></li><li><div>
Develop and maintain the CRB charters as needed.</div></li><li><div>
Manage and troubleshoot imaging upload and transfer workflow.</div></li><li><div>
Partner with clinical sites and core lab(s) to manage and improve subject screening workflow from initial submission to final approval of inclusion for treatment.</div></li><li><div>
Development, review, optimization, and implementation of standard operating procedures related to case review board workstream.</div></li><li><div>
Serve as the primary point of contact and subject matter expert for patient screening process during study start-up</div></li><li><div>
Maintain and optimize case/subject logs, tracking tools, and regular progress reporting.</div></li><li><div>
Maintain, track, and update existing proctor agreements and partner with the contracting team on any new contracts required for expanded trials.</div></li><li><div>
Manage and maintain relevant electronic data management platform activities related to clinical trial enrollment.</div></li><li><div>
Mentor and provide leadership to junior Clinical Affairs team members through individual development plans and department milestones.</div></li><li><div>
Other duties as assigned.</div></li></ul><div><div><b>
Required Education and Experience:
</b></div></div><ul><li><div>5+ years of relevant professional experience in clinical operations, site management, case planning, patient screening, etc. is required (preferred in medical devices).</div></li><li><div>
Strong background in Microsoft Office Suite, especially PowerPoint and Excel.</div></li><li><div>
Experience facilitating Zoom or Microsoft Teams meetings.</div></li><li><div>
Strict attention to detail.</div></li><li><div>
Ability to interact professionally with all organizational levels.</div></li><li><div>
Ability to lead a team and work in a team environment.</div></li><li><div>
Experience in line management and developing direct reports is strongly recommended.</div></li><li><div>
Advanced degree in a biological science / pharmacy/ nursing desired.</div></li></ul><p>
</p><div><div><b>Skills and Abilities Required for This Job:
</b></div></div><ul><li><div>Working knowledge of clinical study execution and patient screen / case planning.</div></li><li><div>
Knowledge of GCPs governing the conduct of clinical trials; working knowledge of Medical Device Regulations 2017/745, ISO 14155 and ICH Guidelines.</div></li><li><div>
Experience in developing and improving processes.</div></li><li><div>
Ability to work collaboratively as part of a multi-functional medical device development team in a dynamic environment.</div></li><li><div>
Must be self-motivated, highly organized, detail-oriented and able to multi-task, delivering high quality work.</div></li><li><div>
Demonstrated ability in oral and written communication skills; excellent interpersonal skills, including the ability to influence and to work effectively cross-culturally and cross-functionally.</div></li><li><div>
Ability to work in a fast-paced work environment within a cross-functional and highly interdependent team structure.</div></li><li><div>
Ability to work pacific standard time hours.</div></li></ul></div>

Manager, Clinical Affairs (Case Review Board)

Johnson & Johnson

<div><p>At Johnson &amp; 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</p><p>
As guided by Our Credo, Johnson &amp; 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 &amp; Johnson, we respect the diversity and dignity of our employees and recognize their merit.</p><p><b>
Job Function:
</b></p>Marketing<p><b>
Job Sub Function:
</b></p>Strategic Marketing<p><b>
Job Category:</b></p>
Professional<p><b>
All Job Posting Locations:</b></p>
Irvine, California, United States of America<p><b>
Job Description:</b></p><p>
Johnson &amp; Johnson MedTech, Electrophysiology, is recruiting a Sr. Marketing - Product Manager to join the team in Irvine, CA.</p><div><div><div><div><div><div><div><div><div><p>
Johnson &amp; 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.</p><p>
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/.
</p><p>Fueled by innovation at the intersection of biology and technology, we&rsquo;re developing the next generation of smarter, less invasive, more personalized treatments.
</p></div></div></div></div></div></div></div></div></div><p><b>Position Summary</b></p><p>
This highly visible role will drive global upstream strategy for Johnson &amp; Johnson MedTech Electrophysiology&rsquo;s Pulse Field Ablation pipeline, shaping long‑term therapy direction and guiding early‑stage product development. You will lead customer insights, influence technology roadmaps, and partner closely with R&amp;D, clinical, medical affairs, regulatory, downstream marketing, and regional commercial teams worldwide.</p><p>
This role requires strong strategic thinking, clinical and technical understanding of electrophysiology, and demonstrated leadership within cross‑functional innovation environments.</p><p><b>
Key Responsibilities</b></p><p><b>
Strategic Market Leadership</b></p><ul><li><p>
Lead global upstream strategy for PFA technology&mdash;ensuring alignment with clinical trends, unmet needs, competitive landscape, and evolving global EP adoption dynamics.</p></li><li><p>
Conduct robust voice‑of‑customer and insights programs (VOC, ethnography, segmentation, JTBD) to guide product strategy.</p></li><li><p>
Build global market models, therapy adoption curves, and long‑range forecasts for PFA‑based treatment pathways.</p></li></ul><p><b>
Product Innovation &amp; Pipeline Development</b></p><ul><li><p>
Translate insights into marketing requirement documents (MRDs) and product requirements for new PFA technologies, catheters, generators, and integrated EP ecosystem solutions.</p></li><li><p>
Partner with R&amp;D during early‑stage concept creation, feasibility assessments, and portfolio prioritization.</p></li><li><p>
Lead value proposition design, user needs definition, and business case development for PFA innovations.</p></li></ul><p><b>
Cross‑Functional Leadership</b></p><ul><li><p>
Collaborate with clinical and medical affairs teams to shape evidence strategy, early clinical evaluations, and KOL engagement specific to PFA.</p></li><li><p>
Work with downstream marketing to ensure cohesive messaging, positioning, and launch readiness.</p></li><li><p>
Align with regional partners across international markets to ensure global relevance and adoption strategies for PFA technologies.</p></li></ul><p><b>
Market Intelligence &amp; Competitive Strategy</b></p><ul><li><p>
Monitor competitive PFA advancements, ecosystem integration, clinical trial outcomes, and regulatory pathways.</p></li><li><p>
Evaluate reimbursement, lab workflow, capital integration, and hospital adoption barriers/opportunities specific to PFA.</p></li><li><p>
Identify strategic partnership or technology opportunities that enhance the long‑term EP portfolio.</p></li></ul><p><b>
Qualifications</b></p><p><b>
Required</b></p><ul><li><p>
Bachelor&rsquo;s degree in engineering, life sciences, biomedical sciences, marketing, or related field.</p></li><li><p>
Minimum <b>7+ years in medical devices</b>, including <b>3+ years in upstream marketing, strategic marketing, or early product development</b>.</p></li><li><p>
Strong understanding of clinical environments&mdash;preferably electrophysiology, AF therapy, interventional cardiology, or related high‑acuity specialties.</p></li><li><p>
Proven ability to lead cross‑functional initiatives and influence senior stakeholders.</p></li><li><p>
Strong financial acumen and experience building market models, forecasts, and business cases.</p></li><li><p>
Excellent communication, strategic thinking, and executive‑level storytelling skills.</p></li></ul><p><b>
Preferred</b></p><ul><li><p>
MBA or relevant advanced degree.</p></li><li><p>
Experience with PFA technologies, EP lab workflows, mapping platforms, or catheter‑based energy delivery systems.</p></li><li><p>
Experience supporting global product launches or collaborating with international markets.</p></li><li><p>
Ability to thrive in ambiguity and drive clarity within early‑stage innovation pipelines.</p></li></ul><div><p>
Johnson &amp; 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.
</p><p><i>Johnson &amp; Johnson is committed to providing an interview process that is inclusive of our applicants&rsquo; needs. If you are an individual with a disability and would like to request an accommodation, </i><b><i>external applicants please contact us via </i></b><b><i>https://www.jnj.com/contact-us/careers</i></b><b><i> . internal employees contact AskGS to be directed to your accommodation resource.</i></b></p></div><p><b>
Required Skills:</b></p><p><b>
Preferred Skills:</b></p>
Brand Marketing, Brand Positioning Strategy, Business Alignment, Business Storytelling, Business Valuations, Cross-Functional Collaboration, Customer Intelligence, Data Analysis, Data-Driven Decision Making, Digital Strategy, Execution Focus, Financial Analysis, Go-to-Market Strategies, Industry Analysis, Market Research, Negotiation, Organizing, Problem Solving, Product Development Lifecycle, Product Portfolio Management, Product Strategies, Program Management, Strategic Thinking, Tactical Planning, Technical Credibility<p><b>
The anticipated base pay range for this position is :</b></p>
$122,000.00 - $212,750.00<p>
Additional Description for Pay Transparency:</p>
This position is eligible to participate in the Company&rsquo;s long-term incentive program.<br>
<br>
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:<br>
<br>
Vacation &ndash;120 hours per calendar year<br>
<br>
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado &ndash;48 hours per calendar year; for employees who reside in the State of Washington &ndash;56 hours per calendar year<br>
<br>
Holiday pay, including Floating Holidays &ndash;13 days per calendar year<br>
<br>
Work, Personal and Family Time - up to 40 hours per calendar year<br>
<br>
Parental Leave &ndash; 480 hours within one year of the birth/adoption/foster care of a child<br>
<br>
Bereavement Leave &ndash; 240 hours for an immediate family member: 40 hours for an extended family member per calendar year<br>
<br>
Caregiver Leave &ndash; 80 hours in a 52-week rolling period10 days<br>
<br>
Volunteer Leave &ndash; 32 hours per calendar year<br>
<br>
Military Spouse Time-Off &ndash; 80 hours per calendar year<br>
<br>
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits</div>

Sr. Marketing - Product Manager (Irvine, CA) Johnson and Johnson, MedTech Electrophysiology

Planet Pharma

<div>
 <p>
  <strong>
   Role Purpose
  </strong>
 </p>
 <p>
  Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.
 </p>
 <p>
  <strong>
   Essential Job Functions
  </strong>
 </p>
 <p>
  Provide cross functional operational support throughout the study lifecycle, investigating data or documentation discrepancies and contributing to process improvements that reduce recurrence during study conduct and closeout
 </p>
 <p>
  Support and coordinate study start up activities, including tracking site readiness, managing essential document collection, and communicating with sites regarding planning and logistics for Site Qualification Visits (SQVs) and Site Initiation Visits (SIVs).
 </p>
 <p>
  Perform remote monitoring visits (qualification, initiation, interim monitoring, close-out) and complete reports as per study monitoring plan
 </p>
 <p>
  Support, interface, and collaborate with site personnel, IRBs/ECs, contractors/vendors, and cross-function company personnel
 </p>
 <p>
  Build and maintain strong working relationships with internal partners (Clinical Operations, Regulatory Affairs, Quality, R&amp;D) and site personnel (Investigators, CRCs, research nurses) to support enrollment, data quality, and site performance.
 </p>
 <p>
  Assist with any site remediation activities, as applicable
 </p>
 <p>
  Complete and maintain relevant global Medical and Clinical Affairs, BU-specific, and study-specific training
 </p>
 <p>
  Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas
 </p>
 <p>
  <strong>
   Required
  </strong>
 </p>
 <p>
  Bachelor's Degree or Equivalent Life Sciences or Nursing
 </p>
 <p>
  3-4 years in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry
 </p>
 <p>
  Experience with electronic data capture.
 </p>
 <p>
  <strong>
   Preferred
  </strong>
 </p>
 <p>
  Licenses and Certifications: Clinical research certification (ACRP or SoCRA, clinical coordinator/ CRA certification)
 </p>
</div>


Clinical Research Associate

NeurOptics

<div>
 <p>
  <strong>
   About NeurOptics
  </strong>
 </p>
 <p>
  NeurOptics is the global leader in the science of pupillometry, advancing neurological patient care through clinically validated, data-driven technology. Driven by a passion to improve patient outcomes, NeurOptics&rsquo; solutions are used across critical care nursing, neurology, neurosurgery, emergency medicine, and critical care medicine to inform high-stakes clinical decision-making.
 </p>
 <p>
  Headquartered in Irvine, California, NeurOptics operates globally with representation in more than 50 countries.
 </p>
 <p>
  At NeurOptics, we are passionate patient advocates. Improving neurological patient outcomes is our life&rsquo;s work.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Role Overview
  </strong>
 </p>
 <p>
  The
  <strong>
   Product Manager
  </strong>
  is a key contributor within NeurOptics&rsquo; Sales and Marketing organization, responsible for
  <strong>
   owning and executing product marketing strategy
  </strong>
  for the company&rsquo;s neuroscience and pupillometry product portfolio.
 </p>
 <p>
  This is a
  <strong>
   high-visibility role
  </strong>
  requiring strong product judgment, clinical understanding, and cross-functional leadership. The Product Manager translates market, customer, and clinical insights into differentiated positioning, effective commercialization strategies, and sustained market expansion across U.S. and international markets.
 </p>
 <p>
  This position is based on site at NeurOptics&rsquo; Corporate Headquarters in Irvine, California.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Professional Development
  </strong>
 </p>
 <p>
  NeurOptics is deeply committed to continuous learning and professional growth. The Product Manager will complete structured onboarding focused on clinical immersion, portfolio knowledge, and internal process alignment. Ongoing development opportunities support advancement in product leadership, strategic thinking, and cross-functional influence throughout tenure at NeurOptics.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Key Responsibilities
  </strong>
 </p>
 <p>
  <strong>
   Product &amp; Portfolio Leadership
  </strong>
 </p>
 <ul>
  <li>
   Own and execute downstream product management strategy for neuroscience and pupillometry products, aligned with corporate objectives and the Sales Game Plan
  </li>
  <li>
   Lead product pre-launch, launch, and post-launch execution for next-generation NPi Pupillometry solutions, including medical devices and data integration products
  </li>
  <li>
   Translate product strategy into clear positioning, pricing strategy, promotional initiatives, and market execution plans
  </li>
 </ul>
 <p>
  <strong>
   Market Strategy &amp; Customer Insights
  </strong>
 </p>
 <ul>
  <li>
   Define market and customer requirements for current and future products through primary research, customer engagement, field presence, and scientific conferences
  </li>
  <li>
   Conduct onsite field work with customers to understand clinical workflows, adoption barriers, and value drivers
  </li>
  <li>
   Monitor competitive, clinical, and healthcare market developments that may impact product or portfolio strategy
  </li>
 </ul>
 <p>
  <strong>
   Sales Enablement &amp; Global Commercial Support
  </strong>
 </p>
 <ul>
  <li>
   Serve as a product subject matter expert, delivering product training, messaging, and strategic support to global sales and distribution teams
  </li>
  <li>
   Develop and deliver marketing communications and presentations to U.S. and international distribution partners aligned with key marketing initiatives and sales priorities
  </li>
  <li>
   Partner with Sales leadership to support strategic accounts, customer meetings, and market expansion initiatives
  </li>
  <li>
   Manages Marketing vendors, software and technologies, including identification and implementation of new platforms and processes
  </li>
 </ul>
 <p>
  <strong>
   Cross-Functional Leadership
  </strong>
 </p>
 <ul>
  <li>
   Lead product-specific core teams in a hub-and-spoke model, coordinating efforts across Sales, Clinical Education, Customer Service, Operations, Regulatory, and other stakeholders
  </li>
  <li>
   Collaborate with Regulatory Affairs to ensure appropriate alignment of product claims and marketing materials
  </li>
  <li>
   Work closely with Customer Service and Clinical teams to ensure service readiness, education, and ongoing support excellence
  </li>
 </ul>
 <p>
  <strong>
   Forecasting, Analytics &amp; Execution
  </strong>
 </p>
 <ul>
  <li>
   Develop and maintain sales forecasts for assigned product lines; communicate insights to Marketing, Sales Management, and Operations
  </li>
  <li>
   Leverage CRM and commercial data to identify trends, opportunities, and risks related to adoption and growth.
  </li>
  <li>
   Manage and update CRM design and functionality in conjunction with Marketing, Sales Management, Customer Service, Operations, Finance, and other stakeholders
  </li>
  <li>
   Support continuous improvement in commercialization effectiveness and execution
  </li>
 </ul>
 <p>
  <strong>
   Field &amp; Industry Engagement
  </strong>
 </p>
 <ul>
  <li>
   Travel with sales and clinical education teams to support sales acceleration, gather market intelligence, and strengthen customer relationships
  </li>
  <li>
   Represent NeurOptics professionally at industry conferences, customer meetings, and scientific forums
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Qualifications
  </strong>
 </p>
 <ul>
  <li>
   Bachelor&rsquo;s degree in Marketing, Business, Biological/Clinical Science, Engineering, or related field
  </li>
  <li>
   MBA preferred
  </li>
  <li>
   5+ years of medical device or healthcare product management or product marketing experience; sales experience a plus
  </li>
  <li>
   Demonstrated experience supporting hospital-based products and familiarity with neuroscience or critical care clinical environments
  </li>
  <li>
   Strong track record of supporting product launches, portfolio growth, and cross-functional initiatives in regulated environments
  </li>
  <li>
   Excellent communication and presentation skills with the ability to influence internal and external stakeholders
  </li>
  <li>
   Strong analytical, financial, and problem-solving skills
  </li>
  <li>
   Proven ability to convert customer and product feedback into actionable marketing and commercialization strategies
  </li>
  <li>
   Highly self-directed, with the ability to manage multiple initiatives and shifting priorities
  </li>
  <li>
   Proficient in Microsoft 365 (Word, Excel, PowerPoint, Outlook) and CRM platforms
  </li>
  <li>
   Ability to travel approximately 30% domestically, with occasional international travel
  </li>
 </ul>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   What We Offer
  </strong>
 </p>
 <p>
  NeurOptics offers a competitive and comprehensive benefits package, including:
 </p>
 <ul>
  <li>
   Competitive compensation (Salary + Bonus)
  </li>
  <li>
   100% employer-paid health benefits for the employee
  </li>
  <li>
   Company-paid vacation, sick time, and holidays
  </li>
  <li>
   Maternity and paternity leave
  </li>
  <li>
   A collaborative, high-performance culture with strong career advancement opportunities
  </li>
  <li>
   Proudly recognized as a
   <strong>
    2025 Top Workplace
   </strong>
   by the
   <em>
    Orange County Register
   </em>
  </li>
 </ul>
 <p>
 </p>
</div>


Product Manager - Medical Device

Edwards Lifesciences

&lt;div&gt;&lt;div&gt;Job Description&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;div&gt;&lt;div&gt;&lt;div&gt;&lt;div&gt;&lt;div&gt;&lt;div&gt;&lt;div&gt;&lt;div&gt;&lt;p&gt;Imagine how your ideas and expertise can change a patient&rsquo;s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients&rsquo; lives. As part of our Clinical Affairs team, you&rsquo;ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient&rsquo;s unmet clinical needs. It&rsquo;s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;b&gt;How you&rsquo;ll make an impact:&lt;/b&gt;&lt;/p&gt;&lt;ul&gt;&lt;li&gt;&lt;p&gt;As the Director of Statistical Programming, you will lead teams of programmers to develop, test, validate, document, maintain and execute programs in SAS to support statistical deliverables within agreed timelines. He/she will mentor and develop programmers and allocate statistical programming resources under the provided project priorities and timeline.&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Facilitate talent management activities to include hiring, training, staff development and succession planning. Mentor and develop team of programmers by providing regular coaching and guidance. Manage people resource allocation of statistical programming.&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Prepare, document, and review programming codes and output for own project and/or as needed to ensure the quality of programming output.&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Review ADS Specs and output for own project and/or other projects&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Ensure analysis data and programming code meet regulatory and company standards and are consistently structured to permit efficient programming, reporting, and review&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Participate in the development of procedures and standards and adherence to existing procedures&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Prepare analysis datasets&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Develop program specification and design documents&lt;/p&gt;&lt;/li&gt;&lt;/ul&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;b&gt;What you&rsquo;ll need (Required):&lt;/b&gt;&lt;/p&gt;&lt;ul&gt;&lt;li&gt;&lt;p&gt;Master&amp;#39;s Degree in Computer Science or Statistics or other related fields &lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;11 Year experience Solid SAS programming experience on clinical data in the pharmaceutical and/or medical device industry.&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;3 years&rsquo; experience Managing statistical programmers&lt;/p&gt;&lt;/li&gt;&lt;/ul&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;b&gt;What else we look for (Preferred):&lt;/b&gt;&lt;/p&gt;&lt;ul&gt;&lt;li&gt;&lt;p&gt;Proven successful project management leadership skills&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Proven expertise in SAS and Windows operating systems required; experience using other software packages (e.g., R, S-Plus)&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Proven expertise in MS Office Suite including Word, PowerPoint, Access, and Excel&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Keeps abreast of new developments in statistics and regulatory guidance&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Expert understanding of clinical trial and statistical programming procedures while addressing issues with impact beyond own team based on knowledge of related disciplines&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Demonstrated track record in people management&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Expert understanding and knowledge relevant to statistical programming&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Expert understanding and knowledge of regulatory guidelines (e.g., GCP, ICH, FDA, ISO) relevant to in Pharmaceutical/Medical Device research setting&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Excellent problem-solving, organizational, analytical and critical thinking skills&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Experience in facilitating change, including collaboration with management and executive stakeholder&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Strict attention to detail&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Ability to interact professionally with all organizational levels&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Ability to manage competing priorities in a fast paced environment&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Must be able to work in a team environment, including participating and presenting at meetings, including with external representatives&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Frequently interacts with customers, and/or functional peer group managers, normally involving matters between cross-functional teams and the company; often leads a cooperative effort among members of a project team&lt;/p&gt;&lt;/li&gt;&lt;li&gt;&lt;p&gt;Participate and present at meetings with internal and external representatives&lt;/p&gt;&lt;/li&gt;&lt;/ul&gt;&lt;/div&gt;&lt;/div&gt;&lt;/div&gt;&lt;/div&gt;&lt;/div&gt;&lt;/div&gt;&lt;/div&gt;&lt;/div&gt;&lt;/div&gt;&lt;p&gt;Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.&lt;br /&gt;&lt;br /&gt;The base pay range for this position is $182,000 to $257,000 (highly experienced).&lt;br /&gt;&lt;br /&gt;The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).&lt;span&gt; &lt;/span&gt;Applications will be accepted while this position is posted on our Careers website.&lt;span&gt; &lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;E&lt;span&gt;dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.&lt;/span&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;/p&gt;&lt;p&gt;&lt;b&gt;COVID Vaccination Requirement&lt;/b&gt;&lt;/p&gt;&lt;p&gt;&lt;span&gt;Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination. &lt;/span&gt;&lt;/p&gt;

Director Statistical Programming

Stone LLP

<p>Warning: This Is Not Your Average Law Firm Case Manager Job.</p><p>Most litigation firms hiring a case manager will bore you to tears with a laundry list of duties and then underpay you for the privilege. We're not most firms.</p><p>Stone LLP is a boutique California litigation powerhouse specializing in business disputes, construction litigation, and real estate law. Our clients come to us when the stakes are high and they need a firm that fights. We win. And we need a sharp, detail-obsessed case manager to help us do it.</p><p><b>Who We're Looking For in a Case Manager</b></p><p>You're not the person who watches the clock. You're the one who notices the typo everyone else missed. You know that a misfiled document can sink a case, a missed deadline can cost a client everything, and &quot;good enough&quot; isn't good enough in litigation.</p><p>You've got at least 2 years of legal case management or litigation support experience, ideally in business, construction, or real estate law. You can run circles around Microsoft Office. You proofread like your reputation depends on it &mdash; because here, it does.</p><p><b>Case Manager Key Responsibilities</b></p><p>You'll be in the mix from day one &mdash; managing client calls, calendaring court appearances and depositions, and supporting attorneys through every phase of litigation including pleadings, discovery, motions, and trial prep. You'll maintain case files, draft correspondence, generate client invoices, file documents with the court, and keep the office running like a well-oiled machine.</p><p>The attorneys focus on winning cases. You make sure nothing falls through the cracks. It's a critical role &mdash; and we treat it that way.</p><p><b>Case Manager Requirements</b></p><ul><li>Associate's degree or paralegal certificate</li><li>2+ years of litigation support or legal case management experience</li><li>Microsoft Office 365 mastery (we mean it &mdash; mastery!)</li><li>Ability to independently prioritize tasks and meet firm deadlines</li><li>Proofreading skills sharp enough to catch a comma splice at 40 paces</li><li>Follow-through that borders on relentless</li></ul><p><b>Why Work at Stone LLP | Business, Construction &amp; Real Estate Litigation</b></p><p>We're small enough that your work actually matters. Big enough that the work is serious and the cases are interesting. We offer competitive pay, real benefits, and a collaborative environment where sharp people get noticed &mdash; and rewarded. Career growth here is real, not a line in a job posting.</p><p><b>How to Apply for the Case Manager Position</b></p><p>Submit your resume and cover letter in PDF format through this posting. Stone LLP is an equal opportunity employer and welcomes candidates of all backgrounds.</p><p>If you read this far and you're still excited &mdash; that's a good sign. Apply.</p><p>Job Type: Full-time</p><p>Pay: $26.00 - $35.00 per hour</p><p>Benefits:</p><ul><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li><li>Tuition reimbursement</li><li>Vision insurance</li></ul><p>Ability to Commute:</p><ul><li>Irvine, CA 92614 (Required)</li></ul><p>Work Location: In person</p>

Case Manager - Onsite

Rep-Lite

<div><h1 class="jobSectionHeader"><b>Medical Device Sales Representative &ndash; Phoenix, AZ</b><br>
<b>Surgical / OR Focus | Territory Ownership | High-Growth Opportunity</b><br>
<b>Are you a proven surgical device rep who thrives in the OR and wants a territory you can truly own?</b></h1><p>
We&rsquo;re partnering with a rapidly growing medical device company expanding across North Carolina and hiring a <b>Phoenix</b> <b>based sales professional with strong OR case coverage experience</b> to drive adoption of innovative surgical technology.</p><p>
This is ideal for someone who wants <b>more autonomy, direct access to leadership, and real income upside</b> - not another corporate territory with capped growth.</p><p></p><h3 class="jobSectionHeader"><b>
What You&rsquo;ll Own:</b></h3><ul><li><p>
Full responsibility for a high-potential Western US region territory</p></li><li><p>
Daily OR case coverage and hands-on clinical support</p></li><li><p>
Building surgeon and clinical champion relationships</p></li><li><p>
Driving new account acquisition and expanding existing business</p></li><li><p>
Leading evaluations, trials, and conversions</p></li><li><p>
Managing your pipeline and territory strategy with independence</p></li></ul><p></p><h3 class="jobSectionHeader"><b>
Must have:</b></h3><ul><li><p><b>
At least 3+ years of medical device sales experience</b></p></li><li><p><b>
Direct OR case coverage experience</b></p></li><li><p>
Experience selling into hospitals, ASCs, and complex clinical environments</p></li><li><p>
Consistent quota achievement and new business wins</p></li><li><p>
Comfortable with early mornings, fast-paced surgical schedules, and clinical environments</p></li><li><p>
Bachelor&rsquo;s degree</p></li><li><p>
Based near major airport</p></li></ul><p></p><h3 class="jobSectionHeader"><b>
Nice to Have:</b></h3><ul><li><p>
Surgical specialties (ortho, spine, ENT, EP, urology, aesthetics, etc.)</p></li><li><p>
Clinical background (RN, scrub tech, military medical)</p></li><li><p>
Startup or high-growth company experience</p></li></ul><p></p><h3 class="jobSectionHeader"><b>
Why Reps Join:</b></h3><ul><li><p>
High-growth territory with significant runway</p></li><li><p>
True ownership and autonomy - minimal red tape</p></li><li><p>
Direct access to leadership and faster decision-making</p></li><li><p>
Innovative products surgeons want to use</p></li><li><p>
Strong compensation upside and advancement potential</p></li></ul><p></p><p>
If you&rsquo;re energized by the OR, enjoy winning new business, and want to build something meaningful - apply today.</p><p>
Rep-Lite receives a large volume of resumes for each position and regretfully cannot respond to each application.</p>
<p>If we have an interest in speaking with you further, we will email a request for a video interview. Sometimes these emails end up in spam/junk so please make sure you are checking them periodically; the sending domain will be @applytojob.com.</p>
<p>Thank you for your interest in Rep-Lite and good luck in your search!</p>
<p></p><p>***&ldquo;Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.</p><p>
</p><p>LSWKzIAIIv</p></div>

Medical Device Sales Representative - 77

Explore 93+ Manager clinical affairs case review board in Irvine this April. Find roles across top companies and apply now to boost your career.