Penumbra

Sr Clinical Study Manager

Territory Manager - Neurovascular & Peripheral Vascular

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Therapy Development Specialist

The Senior Clinical Study Manager leads the planning, design, and execution of clinical studies to assess product safety and effectiveness.  This role involves managing confidential data, interacting with internal/external stakeholders, and developing project timelines from startup to completion. Responsibilities include developing study documents, managing budgets and vendors, conducting site visits, contributing to process improvements, and leading audits. The role requires strong communication, problem-solving, and collaboration skills across various departments (Regulatory Affairs, Marketing, Legal, etc.).  The ideal candidate will have extensive experience in clinical trials, project management, and regulatory compliance.

<div class="section page-centered" data-qa="job-description"><div>The Senior Clinical Study Manager provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products.&nbsp;</div><div><br></div><div>This person will work with confidential subjects and company data, and interface with a variety of internal and external stakeholders.&nbsp;</div><div><br></div><div>The Sr. Clinical Study Manager understands business environment and relates extensive knowledge of internal and external activities to trends. This role also interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.&nbsp;&nbsp;</div><div><br></div><div><u><b>Specific Duties and Responsibilities&nbsp;</b></u></div><div>• Develops/maintains project timeline inclusive of startup through completion (e.g., database build, data snapshots for study reports, abstracts, manuscripts, DSMB, CEC meetings, and regulatory submissions)&nbsp; &nbsp;</div><div>• Drives development, approval, and distribution of study-related documents and study tools for investigational sites and review committees as directed by management.&nbsp;</div><div>• Manages distribution, collection and tracking of regulatory documentation to help ensure audit readiness at both the sites and Penumbra headquarters.&nbsp;</div><div>• Negotiates study budgets with sites, Core Labs, and other vendors.&nbsp;</div><div>• Attends site visits as necessary (e.g., site initiation, monitoring, and close out visits).&nbsp;</div><div>• Contributes to process improvements that help foster continuous improvement.&nbsp;</div><div>• Helps update and maintain study trackers and dashboards.&nbsp;&nbsp;</div><div>• Participates in system user acceptance testing.&nbsp;&nbsp;</div><div>• Manages vendors such as Core Lab.</div><div>• Organizes and manages Investigator Meetings.&nbsp;&nbsp;</div><div>• Works with data management to develop systems for and track project metrics.&nbsp;&nbsp;</div><div>• Leads activities for internal and regulatory audits.&nbsp;</div><div>• Monitor progress of studies, identify study-related trends/issues and with the clinical team, implement corrective actions when necessary.&nbsp;</div><div>• Coordinates activities associated with study start-up and management.&nbsp;</div><div>• Provides solutions to challenges such as enrollment in the clinical study.&nbsp;</div><div>• Represents the Clinical Affairs Department on cross-functional meetings and projects as needed.&nbsp;&nbsp;</div><div>• Works with and communicates effectively with cross functional teams including Regulatory Affairs, Marketing, Legal, Customer Service, R&amp;D, Finance, and Sales.&nbsp;</div><div>• Attends scientific conferences and interacts with key opinion leaders.&nbsp;</div><div>• Maintains proactive communication regarding all study related activities with study PIs.&nbsp;&nbsp;</div><div>• Assists management with regulatory submissions and other clinical study reports.&nbsp;&nbsp;</div><div>• Supports the study team by answering protocol-specific questions (assist in resolution of patient eligibility questions and protocol deviations).&nbsp;</div><div>• Mentors and trains staff regarding protocols, good clinical practice, departmental processes, etc.</div><div>• Assists team members in managing challenging investigators/staff.&nbsp;&nbsp;</div><div>• Assists in selection of vendors, such as Core Labs.&nbsp;&nbsp;</div><div>• Travels as needed to meet project milestones.&nbsp;&nbsp;</div><div>• Leads complex multidisciplinary (stats, DM, clinical) US and OUS clinical projects.</div><div>• Evaluates, analyzes, and interprets data and presents in a clear, well organized, scientifically sound report.&nbsp;</div><div>• Drafts Investigator Meeting content.&nbsp;</div><div>• Forecasts study timelines and budgets.&nbsp;</div><div>• Drives development, approval, and distribution of moderately complex study protocols.</div><div>• Works with data management/biostatistics to develop reports and listings for centralized review of data; reviews data, spots trends to ensure quality of data.&nbsp;&nbsp;</div><div>• Mentors Clinical Study Managers and provides functional support.&nbsp;&nbsp;</div><div>• Clearly understands and communicates project risks.&nbsp;&nbsp;</div><div>• May present and attend at DSMB meetings.&nbsp;&nbsp;</div><div>• Internal audit subject matter expert.&nbsp;&nbsp;</div><div>• Proactively identifies issues within the Clinical Affairs department; proposes and implements preventive action to foster continuous improvement.&nbsp;</div><div>• Actively contributes to study operational strategy.&nbsp;&nbsp;</div><div>• Effectively understands and communicates priorities.&nbsp;&nbsp;</div><div>• Select, manage, train, and develop staff.&nbsp;</div><div>• Establish objectives and assignments and provide ongoing feedback through performance reviews and development plans.&nbsp;</div><div>• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.&nbsp;</div><div>• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.&nbsp;</div><div>• Ensure other members of the department follow the QMS, regulations, standards, and procedures.&nbsp;</div><div>• Perform other work-related duties as assigned.&nbsp; &nbsp;&nbsp;</div><div><br></div><div><u><b>Position Qualifications&nbsp;</b></u></div><div>• Bachelor's degree in Biological Sciences or related field with 7+ years of experience, or equivalent combination of education and experience&nbsp; &nbsp;</div><div>• 7+ years of relevant clinical trial experience required (clinical/scientific research, nursing, or medical devices/pharmaceutical industry)&nbsp;</div><div>• Project management experience including at least 1 clinical project of increasing complexity and at least 1 complex multicenter US/OUS trial.&nbsp;&nbsp;</div><div>• Field experience preferred </div><div>• Medical device, pharmaceutical, biotech, or other regulated industry experience desired&nbsp;</div><div>• Must be familiar with laws, regulations, standards, and guidance governing the conduct of clinical studies including knowledge of CFR and GCP/ICH requirements.&nbsp;</div><div>• Proficiency with Microsoft Office, MS Project, EDC Systems, study management systems, and vendor oversight.&nbsp;</div><div>• Ability to solve problems creatively with keen attention to details; ability to work on teams on multiple projects simultaneously.&nbsp;&nbsp;</div><div>• Working knowledge of medical terminology required.&nbsp; </div><div>• High degree of accuracy and attention to detail&nbsp;&nbsp;</div><div>• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously&nbsp;&nbsp;</div><div>• Excellent oral, written, and interpersonal communication skills with fluency in English and local language, if different is required&nbsp;</div><div><br></div><div><u><b>Working Conditions&nbsp;&nbsp;</b></u></div><div>• General office, laboratory, and cleanroom environments </div><div>• Willingness and ability to work on site. </div><div>• May have business travel from 5% - 15%.&nbsp;&nbsp;</div><div>• Potential exposure to blood-borne pathogens </div><div>• Requires some lifting and moving of up to 10 pounds&nbsp;</div><div>• Must be able to move between buildings and floors.&nbsp; </div><div>• 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.&nbsp; &nbsp;</div><div>• Must be able to read, prepare emails, and produce documents and spreadsheets.&nbsp; &nbsp;&nbsp;</div><div>• Must be able to move within the office and access file cabinets or supplies, as needed.&nbsp;&nbsp;</div><div>• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.&nbsp;</div></div><div class="section page-centered" data-qa="closing-description"><div><b>What We Offer</b></div><div>•A collaborative teamwork environment where learning is constant, and performance is rewarded.</div><div>•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.</div><div>•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, an employee stock purchase plan, 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).</div><div>&nbsp;</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>&nbsp;</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>&nbsp;</div><div>If you reside in the State of California, please also refer to&nbsp;<a href="https://www.penumbrainc.com/pdf/privacynotice/">Penumbra's Privacy Notice for California Residents.</a></div><div>&nbsp;</div><div>For additional information on Penumbra’s commitment to being an equal opportunity employer, please see&nbsp;<a href="https://tinyurl.com/Penumbra-AAP-Policy-Statement">Penumbra's AAP Policy Statement.</a></div></div><div class="section page-centered" data-qa="closing-description"><div><b>What We Offer</b></div><div>•A collaborative teamwork environment where learning is constant, and performance is rewarded.</div><div>•The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.</div><div>•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, an employee stock purchase plan, 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).</div><div>&nbsp;</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>&nbsp;</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>&nbsp;</div><div>If you reside in the State of California, please also refer to&nbsp;<a href="https://www.penumbrainc.com/pdf/privacynotice/">Penumbra's Privacy Notice for California Residents.</a></div><div>&nbsp;</div><div>For additional information on Penumbra’s commitment to being an equal opportunity employer, please see&nbsp;<a href="https://tinyurl.com/Penumbra-AAP-Policy-Statement">Penumbra's AAP Policy Statement.</a></div></div>undefined

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Adyen

Team Lead - Documentation

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The Team Lead - Documentation role at Adyen involves leading a team of writers to create documentation for developers, including API documentation, SDKs, Release Notes, and integration guides. The lead will support the team's projects and professional growth, ensure a great docs experience, and help automate and optimize documentation and tooling. The role also includes partnering on strategic initiatives with the Global Team Lead and collaborating with stakeholders to understand their needs, advance business goals, and socialize the team's impact.

<p>Adyen is a technology company that provides a single platform to accept payments anywhere in the world through any sales channel. Driven by a vision to improve customer experience, streamline processes, and ultimately increase revenue, Adyen enables businesses to process payments across online, mobile, and Point-of-Sale (POS) with over 250 payment methods in 187 transaction currencies. Over 3,500 businesses use the Adyen payment platform, including Facebook, Airbnb, Spotify, Groupon, Evernote, Booking.com, Yelp, Vodafone, Mango, Abercrombie &amp; Fitch, O’Neill, and KLM. Adyen is headquartered in Amsterdam, with offices in San Francisco, São Paulo, Singapore, London, Paris, Berlin, Stockholm, Madrid, and Boston.</p><p><br></p>

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<h3><strong>This is Adyen</strong></h3> <p><span style="font-weight: 400;">Adyen provides payments, data, and financial products in a single solution for customers like Meta, Uber, H&amp;M, and Microsoft - making us the financial technology platform of choice. At Adyen, everything we do is engineered for ambition.&nbsp;</span></p> <p><span style="font-weight: 400;">For our teams, we create an environment with opportunities for our people to succeed, backed by the culture and support to ensure they are enabled to truly own their careers. We are motivated individuals who tackle unique technical challenges at scale and solve them as a team. Together, we deliver innovative and ethical solutions that help businesses achieve their ambitions faster.</span></p> <p>&nbsp;</p> <h3><strong>Team Lead - Documentation</strong></h3> <p>Technical writers at Adyen play a key role in connecting our external users, developers, product teams, developer advocates, and support teams. As our product and development teams expand globally, we're searching for a Documentation Team Lead to partner with the Global Documentation Team Lead. Together, you will guide a talented group of writers who are instrumental in documenting our high-impact solutions for a developer audience including: API documentation, SDKs, Release Notes, and integration guides.</p> <p>In this role, you will work closely with the Global Documentation Team Lead, contributing to strategic initiatives and directly managing a team focused on creating exceptional documentation for our developer community.</p> <p>&nbsp;</p> <h3><strong>What you'll do</strong></h3> <p><strong>Lead a high-performing team of writers</strong></p> <ul> <li>Support the projects and professional growth of writers as they document complex product capabilities</li> <li>Help your team deliver a docs experience that developers will love</li> <li>Help strategize solutions to automate and optimize our docs and tooling</li> </ul> <p><strong>Partner on driving strategic initiatives</strong></p> <ul> <li>Set your team’s priorities in alignment with broader business goals</li> <li>Collaborate with the Global Team Lead on strategic initiatives for the Developer Experience and Docs teams</li> <li>Co-lead and execute Adyen’s AI developer experience strategy</li> </ul> <p><strong>Help build and drive collaborative engagement</strong></p> <ul> <li>Engage with stakeholders and collaborators in Product, Engineering, UX, Support, and other functions to understand their business needs, identify opportunities for partnership, advance business goals, and socialize your team's value and impact</li> <li>Remove blockers and improve ways of working across teams</li> </ul> <p>&nbsp;</p> <h3><strong>Who you are</strong></h3> <ul> <li>Minimum 2-3 years experience managing documentation teams, preferably in API docs</li> <li>Experience in leading documentation projects and initiatives (for example, scaling or automation solutions, or migration to new tooling or workflows)</li> <li>Able to work on multiple projects simultaneously in a fast-paced, dynamic environment</li> <li>Experience working with cross-functional leads and stakeholders, gathering support and buy-in for key initiatives&nbsp;</li> <li>Ability to effectively inspire, influence, and communicate across all levels of management</li> <li>Partner effectively with developers, product managers, and technical writers to deliver quality documentation</li> <li>Experience writing documentation for UI components, SDKs, and APIs a strong plus</li> <li>Proficiency in using Git and working with a docs-as-code workflow is helpful</li> <li>Open to some domestic and international travel</li> </ul> <p>&nbsp;</p> <p><em>The annual base salary range for this role is $180,000 - $243,000; to learn more about our compensation philosophy, please click </em><a href="https://docs.google.com/document/d/11U2tgFev7p271JMQWMApZjtpJ3pGHNES7EvscXnsH3k/edit?usp=sharing"><em>here</em></a><em>.</em></p> <p>&nbsp;</p> <p><strong>Our Diversity, Equity and Inclusion commitments&nbsp;</strong></p> <p><span style="font-weight: 400;">Our unique approach is a product of our diverse perspectives. This diversity of backgrounds and cultures is essential in helping us maintain our momentum. Our business and technical challenges are unique, and we need as many different voices as possible to join us in solving them - voices like yours. No matter who you are or where you’re from, we welcome you to be your true self at Adyen.&nbsp;</span></p> <p><span style="font-weight: 400;">Studies show that women and members of underrepresented communities apply for jobs only if they meet 100% of the qualifications. Does this sound like you? If so, Adyen encourages you to reconsider and apply. We look forward to your application!</span></p> <p>&nbsp;</p> <p><strong>What’s next?</strong></p> <p><span style="font-weight: 400;">Ensuring a smooth and enjoyable candidate experience is critical for us. We aim to get back to you regarding your application within 5 business days. Our interview process tends to take about 4 weeks to complete, but may fluctuate depending on the role. </span><a href="https://careers.adyen.com/how-we-hire"><span style="font-weight: 400;">Learn more about our hiring process here</span></a><span style="font-weight: 400;">. Don’t be afraid to let us know if you need more flexibility.</span></p> <p><span style="font-weight: 400;">Adyen is an equal opportunity employer. We do not discriminate based on race, color, ethnicity, ancestry, national origin, religion, sex, gender, gender identity, gender expression, sexual orientation, age, disability, veteran status, genetic information, marital status or any legally protected status.</span></p> <p><span style="font-weight: 400;">All your information will be kept confidential according to EEO guidelines.</span></p> <p>&nbsp;</p> <p><em><span style="font-weight: 400;">This role is based out of our Chicago office. We are an office-first company and value in-person collaboration; we do not offer remote-only roles. This role is hybrid, with 3 days per week in the Chicago office.</span></em></p>

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