Penumbra

Sr Clinical Study Manager

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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.

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<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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The Chargeback Specialist will handle disputes and chargebacks, act as an interface between the PhonePe Customer Support team, internal technical teams, and external businesses/services. They are responsible for resolving both technical and non-technical issues raised by customers on the PhonePe platform. This involves analyzing disputes, developing and monitoring solutions, providing feedback, maintaining records of problem analysis, and troubleshooting customer payment issues. They are expected to provide timely and accurate resolution to customer issues, address chronic system issues, provide process improvements, develop internal documentation and contribute to a team environment.

<p><span style="color: rgba(0, 0, 0, 0.6);">PhonePe was founded in December 2015 and has emerged as India’s largest payments app, enabling digital inclusion for consumers and merchants alike. </span></p>

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<div><p><strong>About PhonePe Group:&nbsp;</strong></p> <p>PhonePe is India’s leading digital payments company with 50 crore (500 Million) registered users and 3.7 crore (37 Million) merchants covering over 99% of the postal codes across India. On the back of its leadership in digital payments, PhonePe has expanded into financial services (Insurance, Mutual Funds, Stock Broking, and Lending) as well as adjacent tech-enabled businesses such as Pincode for hyperlocal shopping and Indus App Store which is India's first localized App Store. The PhonePe Group is a portfolio of businesses aligned with the company's vision to offer every Indian an equal opportunity to accelerate their progress by unlocking the flow of money and access to services.</p> <p><strong><span style="font-family: tahoma, sans-serif;"><span style="color: #000000;">Culture</span></span></strong></p> <p style="text-align: justify;"><span style="font-weight: 400;">At PhonePe, we take extra care to make sure you give your best at work, Everyday! And creating the right </span><span style="font-weight: 400;">&nbsp;</span><span style="font-weight: 400;">environment for you is just one of the things we do. We empower people and trust them to do the right </span><span style="font-weight: 400;">&nbsp;</span><span style="font-weight: 400;">thing. Here, you own your work from start to finish, right from day one. Being enthusiastic about tech is a </span><span style="font-weight: 400;">&nbsp;</span><span style="font-weight: 400;">big part of being at PhonePe. If you like building technology that impacts millions, ideating with some of </span><span style="font-weight: 400;">&nbsp;</span><span style="font-weight: 400;">the best minds in the country and executing on your dreams with purpose and speed, join us!</span></p> <p><iframe src="https://www.linkedin.com/embed/feed/update/urn:li:ugcPost:6602432465934082048?compact=1" width="380" height="214"></iframe></p></div><div><p><strong>JOB DESCRIPTION</strong></p> <p>&nbsp;</p> <table> <tbody> <tr> <td> <p><strong>Job Objective:</strong>&nbsp;</p> <p>We are looking for someone who can handle disputes/chargebacks, handle stakeholders,&nbsp; be the interface&nbsp; for PhonePe Customer Support team, internal technical team and external business / services. Responsible for providing timely and accurate resolution to both technical &amp; non technical issues raised by customers on the PhonePe platform.</p> <p>A Recon Specialist&nbsp; is expected to address chronic system issues, provide process improvements, develop internal documentation and contribute to a team environment, all while adhering to service level agreements.</p> </td> </tr> <tr> <td> <p><strong>Role Expectations:&nbsp;</strong></p> <p><strong>&nbsp;</strong></p> <ul> <li>Analysis of disputes/chargebacks with end to end closure post discussion with relevant stakeholders.</li> <li>Developing, owning and monitoring solutions for production and non-production environments and applications.</li> <li>Flexible to take up extra Initiative or additional work as per the organizational requirement&nbsp;</li> <li>Provide feedback from customer users to the team.</li> <li>Maintain on-going record of problem analysis and resolution activity in an on-call tracking system Desired Skills &amp; Education.</li> <li>Diagnosing, troubleshooting and fixing issues related to Customer payments.</li> </ul> </td> </tr> <tr> <td> <p><strong>Experience, Skills, Qualifications:</strong></p> <br> <ul> <li>2-3 years of experience in dispute management and in NPCI products.</li> <li>Proven success in a fast paced production support environment.&nbsp;</li> <li>Good in problem solving and analytical skills.&nbsp;</li> <li>Demonstrated ability to communicate effectively in writing, ideally with a successful track&nbsp;</li> <li>Record of responding to/resolving customer issues through written communication Excellent written and oral communications skills&nbsp;</li> <li>Prior experience in e-commerce or payments / web services domain as a Technical support executive • Ability to effectively work with cross functional teams.</li> <li>&nbsp;Possess ability to understand business problems and provide solutions/information related to the business requirements.&nbsp;</li> </ul> </td> </tr> </tbody> </table> <p>&nbsp;</p></div><div><p><strong>PhonePe Full Time Employee Benefits (Not applicable for Intern or Contract Roles)</strong></p> <ul> <li style="text-align: left;"><strong>Insurance Benefits - </strong><span style="font-weight: 400;">Medical Insurance, Critical Illness Insurance, Accidental Insurance, Life Insurance</span></li> <li style="text-align: left;"><strong>Wellness Program -</strong><span style="font-weight: 400;"> Employee Assistance Program, Onsite Medical Center, Emergency Support System</span></li> <li style="text-align: left;"><strong>Parental Support - </strong><span style="font-weight: 400;">Maternity Benefit, Paternity Benefit Program, Adoption Assistance Program, Day-care Support Program</span></li> <li style="text-align: left;"><strong>Mobility Benefits - </strong><span style="font-weight: 400;">Relocation benefits, Transfer Support Policy, Travel Policy</span></li> <li style="text-align: left;"><strong>Retirement Benefits - </strong><span style="font-weight: 400;">Employee PF Contribution, Flexible PF Contribution, Gratuity, NPS, Leave Encashment&nbsp;</span></li> <li style="text-align: left;"><strong>Other Benefits - </strong><span style="font-weight: 400;">Higher Education Assistance, Car Lease, Salary Advance Policy</span></li> </ul> <p style="text-align: justify;"><strong><em>Working at PhonePe is a rewarding experience! Great people, a work environment that thrives on creativity, the opportunity to take on roles beyond a defined job description are just some of the reasons you should work with us. Read more about PhonePe <a href="https://blog.phonepe.com/tagged/people" target="_blank">on our blog</a>.</em></strong></p> <p><a href="https://www.phonepe.com/careers/" target="_blank"><strong>Life at PhonePe</strong></a></p> <p><a href="https://www.phonepe.com/press/" target="_blank"><strong>PhonePe in the news</strong></a></p></div></div><div class="divider" role="separator"></div>

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