Qureos Mentor

Penumbra

<div><div><b>General Summary</b></div>
<div>The Field Clinical Research Associate III participates in the designing and executing of clinical studies sponsored by Penumbra to assess safety and effectiveness of products. This position works with confidential patient and company data, and interfaces with a variety of internal and external stakeholders. This opportunity is open to qualified applicants across the US. Regretfully, sponsorship is not available for this position.</div><br>
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<div><b>Specific Duties and Responsibilities</b></div>
<ul><li>Serve as the site manager, ensuring data entry and query resolution within a timely manner, as well as ensure the overall high-quality data is reported and audit readiness at the clinical site. *</li></ul>
<ul><li>Participates in the monitoring functions in a clinical study including site management, qualification, initiation, routine monitoring, and final close out visits. *</li></ul>
<ul><li>Monitors, onsite and remotely, ongoing compliance to study protocols and site adherence to global regulatory guidelines, including safety reporting. *</li></ul>
<ul><li>Prepares and participates in presentation of protocols and other study conduct requirements at study initiation visits, including training at investigational sites when needed. *</li></ul>
<ul><li>Manages device accountability, inventory, and distribution, with some oversight responsibilities of device complaint/malfunction processing and tracking. *</li></ul>
<ul><li>Manages distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Penumbra trial master file, and for audit readiness. *</li></ul>
<ul><li>Conducts site visits as necessary. Acting as a company liaison, works with clinical sites to resolve any site related issues quickly and effectively. *</li></ul>
<ul><li>Assists Clinical team with the development, approval, and distribution of study-related documents including Case Report Forms (CRF&rsquo;s), study protocols, study manuals, and other study tools to investigational sites and review committees. *</li></ul>
<ul><li>Drafts informed consents with minimal supervision from Clinical Management. *</li></ul>
<ul><li>Provides mentoring to junior staff regarding protocols, site management/monitoring, etc.*</li></ul>
<ul><li>Participates in maintaining project timeline and preparing routine operations reports. *</li></ul>
<ul><li>Collaborates in the development and/or maintenance of Clinical infrastructure such as</li></ul>
<div>the drafting or reviewing of SOP&rsquo;s and Work Instructions. *</div>
<ul><li>Adhere to the Company&rsquo;s Quality Management System (QMS) as well as domestic and</li></ul>
<div>global quality system regulations, standards, and procedures. *</div>
<ul><li>Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *</li></ul>
<ul><li>Ensure other members of the department follow the QMS, regulations, standards, and procedures. *</li></ul>
<ul><li>Perform other work-related duties as assigned. *</li></ul>
<ul><li><i>Indicates an essential function of the role</i></li></ul><br>
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<div><b>Position Qualifications</b></div>
<div><b>Minimum education and experience:</b></div>
<ul><li>Bachelor&rsquo;s degree required, with a major in Biological sciences or a health-related field (e.g., Biology, chemistry, Biochemistry, nursing, Biomedical or Veterinary Sciences) with 5+ years of experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry required, and 2+ years of clinical monitoring experience required or equivalent combination of education and experience.</li></ul>
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<div><b>Additional qualifications:</b></div>
<ul><li>Strong knowledge of medical terminology required.</li></ul>
<ul><li>Strong knowledge of laws, regulations, standards and guidance governing the conduct of clinical studies preferred.</li></ul>
<ul><li>Excellent verbal, written, and interpersonal communication skills.</li></ul>
<ul><li>Strong organizational and problem-solving skills with ability to prioritize assignments while handling various projects simultaneously; keen attention to detail.</li></ul>
<ul><li>Advanced level of competence in Word, Excel, PowerPoint or equivalent programs.</li></ul>
<ul><li>Ability to work on teams and with multiple projects.</li></ul>
<ul><li>Ability to provide guidance and mentoring to junior Clinical staff.</li></ul><br>
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<div><b>Working Conditions</b></div>
<ul><li>General office, laboratory, and hospital environments.</li></ul>
<ul><li>Approximately 40-60% travel to research laboratories or hospitals, conferences and /or other Penumbra affiliated facilities.</li></ul>
<ul><li>Potential exposure to blood-borne pathogens and other potentially infectious materials.</li></ul>
<ul><li>The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.</li></ul><br>
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<div><b>Annual Base Salary Range: $113,000 - $140,000</b></div>
<div>This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range<i>.
</i></div><div>We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.</div><br>
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<div><b>What We Offer</b></div>
<ul><li>A collaborative teamwork environment where learning is constant, and performance is rewarded.</li></ul>
<ul><li>The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.</li></ul>
<ul><li>A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&amp;D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).</li></ul>
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<div>Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.</div>
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<div>Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.</div>
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<div>If you reside in the State of California, please also refer to <b>Penumbra's Privacy Notice for California Residents.</b></div>
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<div>For additional information on Penumbra&rsquo;s commitment to being an equal opportunity employer, please see <b>Penumbra's AAP Policy Statement.</b></div></div>

Field CRA III (Field Clinical Research Associate III )

<div><div><p><b>General Summary</b><br>
The Manager of Statistical Programming will manage a team of statistical programmers engaged in medical device clinical research activities. The Manager of Statistical Programming provides statistical programming support for multiple projects through own efforts and those of staff for assigned projects. The manager builds relationships and promotes collaboration across functions with internal colleagues in Statistics, Data Management, Scientific Communications, Regulatory Medical Writing, and Clinical Study Management. This individual is responsible for ensuring the quality, integrity, and timely delivery of programming deliverables supporting clinical studies, publications, and regulatory submissions. The role drives programming standards, process improvements, innovations, and continuous improvement.</p><br>
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Specific Duties and Responsibilities</b><br>
<ul><li>Select, manage, train, and develop staff. Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans. *</li><li>Lead a team of statistical programmers. Attract, recruit, hire, and retain new staff.*</li><li>Lead resource planning for statistical programming team, including forecasting of employees and external resources (contractors, temps, CRO, consultants). *</li><li>Oversee team effort related to derive data sets and programs, and analysis data set specifications. *</li><li>Ensure consistency analysis of data sets following appropriate standards for clinical studies. Ensure consistency within a therapeutic area.</li><li>Develop and oversee the development of statistical code for the creation of Tables, Listings and Figures for clinical studies. *</li><li>Ensure that all quality processes are followed. Determine the scope of code verification and ensure completeness of verification for assigned projects. *</li><li>Provide input into the development of CRFs and database designs, and definitions. Participate in the development of CRFs, edit check specifications, and data validation reports.</li><li>Participate in the review of SAP and Shells. Interpret the statistical analysis plans and develop analysis of dataset specifications. *</li><li>Creation documentation for regulatory filings including reviewers, guides, and data definition documents. *</li><li>Monitor and quantify efficiency, accuracy, and timeliness of the group.</li><li>Ensure that appropriate concepts and techniques are implemented for clinical studies.</li></ul>
Responsible for monitoring regulatory guidance and industry best practices related to output design and programming conventions.<br>
<ul><li>Ensure efficient programming techniques are utilized by programmers.</li><li>Work collaboratively with multiple stakeholders, propose solutions for potential problems within and across projects, and develop appropriate contingency plans.</li><li>Lead the development of standard code (e.g., SAS, R, Python, Git) and the development of standard operating procedures. Maintain expertise in SAS macros and propose new macros. Mentor others on existing Macros. Oversee the development of new SAS Macros. *</li><li>Manage CROs and other outside vendors for statistical programming activities for clinical studies when appropriate for clinical study data analysis needs. Oversees outsourced programming by providing ongoing reviews of activities and progress to ensure projects are delivered on time with suitable quality.</li><li>Adhere to the Company&rsquo;s Quality Management System (QMS) as well as domestic and</li></ul>
global quality system regulations, standards, and procedures. *<br>
<ul><li>Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *</li><li>Ensure other members of the department to follow the QMS, regulations, standards, and procedures. *</li><li>Perform other work-related duties as assigned.</li><li><i>Indicates an essential function of the role</i></li></ul></div><br>
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Required Qualifications</b><br>
<b>Minimum education and experience:</b><br>
<ul><li>Bachelor&rsquo;s degree in Statistics, Data Science, Computer Science, Mathematics, or related field with 8+ years of experience or equivalent combination of education and experience.</li><li>In-depth knowledge of statistical programming concepts and techniques related to medical devices or drug development is required.</li></ul></div>
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Preferred Qualifications:</b><br>
<ul><li>Master&rsquo;s or higher degree preferred in Statistics, Data Science, Computer Science, Mathematics, or related field with 6+ years of relevant experience.</li><li>1+ years of experience in a supervisory role desired.</li><li>Strong leadership and interpersonal skills are highly desired.</li><li>Medical device, pharmaceutical, biotech, or other regulated industry experience desired.</li><li>Regulatory filing experience preferred.</li><li>Experience with clinical trials, including familiarity with expectations of regulatory agencies (e.g., FDA, PDMA) preferred.</li><li>Able to effectively represent the clinical statistical programming function in cross functional teams.</li><li>Able to accurately estimate the effort required for project related programming activities.</li><li>High degree of technical competence and communication ability, both oral and written.</li><li>Understanding of ICH guidelines and relevant regulatory requirements.</li><li>Excellent problem-solving skills, with a demonstrated ability to guide programmers.</li><li>Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously.</li><li>High degree of accuracy and attention to detail.</li><li>Competent in statistical programming and Macro development.</li></ul></div><br>
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<div><b>
Working Conditions</b><br>
<ul><li>General office environment.</li><li>Willingness and ability to work on site. May have business travel from 5% - 10%.</li><li>Requires some lifting and moving of up to 10 pounds.</li><li>Must be able to move between buildings and floors.</li><li>Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.</li><li>Must be able to read, prepare emails, and produce documents and spreadsheets.</li><li>Must be able to move within the office and access file cabinets or supplies, as needed.</li><li>Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.</li></ul></div><br>
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Annual Base Salary Range: $158,000 - $227,000</b>
<br>
This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.</p>
</div>
<div><b>What We Offer</b></div>
<ul><li>A collaborative teamwork environment where learning is constant, and performance is rewarded.</li></ul>
<ul><li>The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.</li></ul>
<ul><li>A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&amp;D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).</li></ul>
<div></div>
<div>Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.</div>
<div></div>
<div>Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.</div>
<div></div>
<div>If you reside in the State of California, please also refer to <b>Penumbra's Privacy Notice for California Residents.</b></div>
<div></div>
<div>For additional information on Penumbra&rsquo;s commitment to being an equal opportunity employer, please see <b>Penumbra's AAP Policy Statement.</b></div></div>

Manager, Statistical Programming

Join Penumbra and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

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Field CRA III (Field Clinical Research Associate III )

Manager, Statistical Programming