Senior Manager, Clinical Compliance & Inspection Readiness

Join Olema Pharmaceuticals as a Senior Manager, Clinical Compliance & Inspection Readiness, where you will play a pivotal role in ensuring our clinical operations meet the highest standards of compliance and readiness for inspections. You will lead initiatives that drive adherence to regulatory requirements and best practices, helping us bring innovative the…

Become a Pioneer in the Sleep Fitness RevolutionJoin Eight Sleep, where our mission is to enhance human potential through exceptional sleep quality. As the world's first sleep fitness company, we are transforming the concept of well-being and creating cutting-edge hardware, software, and AI technology to facilitate optimal sleep. Our innovative products are designed to maximize mental, physical, and emotional performance, turning each night into a personalized, data-driven recovery session. Trusted by elite athletes and health-conscious individuals across over 30 countries, we are at the forefront of the sleep revolution.Featured as one of Fast Company's Most Innovative Companies in multiple years, we are committed to building a high-performance team that prioritizes speed, focus, and impactful results. Our culture is characterized by an obsession with detail and continuous improvement to ensure our members achieve better sleep and stronger mornings.Unwavering Standards and CommitmentOur intensity reflects the demands of our mission at Eight Sleep. We strive for excellence, inspired by the dedication of top performers worldwide. We are a team that operates with focus and tenacity, constantly pushing to excel in our craft. This is not a conventional 9-to-5 job. Our team is deeply engaged, often going above and beyond because we are passionate about our work.If you thrive under pressure and seek to make a significant impact in your career, you will find your place here. However, if you prefer an easy-going environment, this may not be the role for you.Your RoleWe are in search of a Senior Clinical Trial Manager to oversee the comprehensive execution of our clinical studies, including regulatory trials. This operationally intensive role requires a hands-on approach and expertise in initiating studies from the ground up, managing third-party clinical sites, drafting IRB and informed consent documents, overseeing data management, and ensuring timely and budget-compliant study completion.You will serve as a vital link between our internal teams and external clinical sites, investigators, IRBs, CROs, and, when needed, study participants. A strong understanding of regulatory requirements for medical devices and a proven track record of successful clinical study delivery supporting regulatory submissions are essential.

Veeva Systems is not just a leader in the industry cloud; we are a mission-driven organization dedicated to accelerating the delivery of therapies to patients. As one of the fastest-growing SaaS companies in history, we achieved over $2 billion in revenue last fiscal year and are poised for continued growth.At Veeva, our core values—Do the Right Thing, Customer Success, Employee Success, and Speed—guide our actions. We made history in 2021 by becoming a public benefit corporation (PBC), committed to balancing the interests of all stakeholders, including customers, employees, society, and investors.As a Work Anywhere company, we champion flexible work arrangements, allowing you to thrive in an environment that suits you best, be it at home or in the office.Join us in transforming the life sciences industry and making a meaningful impact on our customers, employees, and communities.

At Olema Oncology, we are committed to innovating and advancing the field of breast cancer treatment and beyond. Our flagship program, palazestrant (OP-1250), is a pioneering complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer, showcasing significant potential as both a standalone therapy and in combination with other treatments for ER+/HER2- metastatic breast cancer. Additionally, our subsequent product candidate, OP-3136, is a KAT6 inhibitor that stands out as best-in-class.We believe that our scientific achievements are propelled by a collaborative environment where we support, inspire, and challenge each other. At Olema, prioritizing the well-being of our team translates into exceptional results. If you are ready to be part of a transformative journey that deeply impacts the lives of our patients and enhances your career, we invite you to join us.For more insights, please check our latest corporate presentations here.About the Role: Senior Manager, Quality Document Control and ComplianceThe Senior Manager of Quality Document Control and Compliance will be a key player in our operations, reporting directly to the Director of Quality Systems. This role will oversee the daily operations of Veeva Vault QDocs, leading document management processes and ensuring compliance standards are met. Responsibilities include but are not limited to the creation and processing of document change control documentation in Veeva QDocs, management of standard operating procedures (SOPs), and GXP documentation, as well as overseeing GXP record processing and archival. You will also be responsible for maintaining document control compliance KPIs and generating metrics for management review.This position is based in our Boston, Massachusetts office and may require approximately 15% travel.Your primary responsibilities will encompass:Acting as the Veeva Vault QDocs Administrator and document control manager.Processing document change control (DCC) for GxP controlled documents in Veeva.Formatting finalized documents to adhere to effective templates.Proofreading and finalizing documents for processing in Veeva QDocs.Collaborating closely with various functional areas to develop, update, manage, and maintain GxP controlled documents.

Join our dynamic team at Alimentiv as a Senior Clinical Operations Lead, where you will play a pivotal role in shaping the future of clinical trials. We are looking for a strategic thinker with extensive experience in clinical operations to lead our initiatives and ensure the successful execution of clinical studies.

Veeva Systems Inc. is a forward-thinking organization and a leader in cloud solutions for the life sciences sector, dedicated to accelerating the process of bringing new therapies to patients. As one of the fastest-growing SaaS companies globally, we achieved over $2 billion in revenue last fiscal year and are poised for further growth.At Veeva, our core values drive us: We prioritize doing the right thing, achieving customer success, fostering employee success, and ensuring speed in our operations. In 2021, we made history by becoming a public benefit corporation (PBC), which legally commits us to balance the interests of our customers, employees, society, and investors.As a Work Anywhere company, we empower you to choose your work environment, whether from home or the office, to help you thrive in your preferred setting.Join us on our mission to transform the life sciences industry and make a meaningful impact on our customers, employees, and the communities we serve.

Join our dynamic team at Precede as a Senior Clinical Laboratory Associate, where your expertise will play a pivotal role in advancing our clinical testing capabilities. You will lead laboratory operations, ensuring the highest standards of quality and accuracy in all testing procedures.Your responsibilities will include overseeing clinical trials, managing laboratory staff, and collaborating with cross-functional teams to interpret complex data. We are looking for a detail-oriented professional who thrives in a fast-paced environment and is passionate about contributing to innovative health solutions.

The Alliance for Clinical Trials in Oncology Foundation is dedicated to advancing cancer clinical research by expanding the capabilities of the Alliance for Clinical Trials in Oncology. Our mission is to address significant treatment challenges through large-scale clinical trials aimed at discovering innovative methods for the prevention, treatment, and cure of various cancers, including leukemia, lymphoma, and solid tumors such as breast, prostate, lung, and gastrointestinal cancers. We also strive to educate the medical community on effective cancer diagnosis, treatment, and prevention strategies.In 2014, we established the Alliance Foundation Trials, LLC (AFT), a wholly-owned subsidiary focused on conducting impactful cancer clinical research in collaboration with industry partners.We are currently seeking a Clinical Research Associate (CRA) to play a crucial role in the management and execution of clinical trial operations across AFT studies. The CRA will be responsible for site management and study start-up activities, including conducting feasibility assessments, supporting site selection, maintaining trial master files (eTMF), and overseeing clinical trial management systems (CTMS). The ideal candidate will work closely with CROs, vendors, and investigative sites to ensure compliance with ICH GCP guidelines and organizational standards throughout the study lifecycle. Join our team of dedicated professionals passionate about transforming cancer care.

Whoop, Inc. is seeking a Senior Hardware Compliance Engineer based in Boston, MA. This role focuses on ensuring that hardware products meet all relevant compliance and regulatory standards. The position plays a key part in upholding quality and safety across the company’s devices. Role overview The Senior Hardware Compliance Engineer will work closely with product and engineering teams to confirm that each hardware release aligns with required regulations. Attention to detail and a strong understanding of compliance processes are essential for success in this position. What you will do Oversee compliance and regulatory requirements for hardware products Support efforts to maintain high standards of quality and safety Contribute expertise to help guide product teams through certification processes Requirements Experience with hardware compliance and regulatory standards Strong commitment to quality and safety in product development

Join Whoop as a Senior Program Specialist in our Risk & Compliance Operations team. In this pivotal role, you will be responsible for developing and implementing compliance strategies that align with regulatory requirements while driving operational excellence. You will collaborate with cross-functional teams to ensure that compliance practices are effectively integrated into our workflows, safeguarding our organization’s integrity and reputation.

At Veeva Systems, our mission is to accelerate the delivery of therapies to patients through innovative cloud solutions tailored for the life sciences industry. As a trailblazer in the SaaS sector, we achieved over $3 billion in revenue last fiscal year and are poised for significant future growth. Our core values—Doing the Right Thing, Customer Success, Employee Success, and Speed—guide every aspect of our operations. In 2021, we distinguished ourselves by becoming a public benefit corporation, legally committed to balancing the interests of all stakeholders including customers, employees, society, and investors. As a Work Anywhere organization, we empower our employees to work in their preferred environments, whether from home or in the office, fostering their success and well-being. Join us as we transform the life sciences industry and create a positive impact for our customers, employees, and communities.

Join Whoop as a Clinical Product Manager, where you will play a pivotal role in shaping the future of health technology. In this dynamic position, you will collaborate with cross-functional teams to develop innovative clinical solutions that enhance user experiences and outcomes. Your expertise will be essential in driving product development from conception to launch, ensuring that our offerings align with clinical standards and user needs.

Join Veeva Systems, a trailblazer in the industry cloud space, dedicated to accelerating the delivery of therapies to patients worldwide. As one of the most successful SaaS companies in history, we achieved over $2 billion in revenue last year, with substantial growth opportunities ahead.Our core values – Do the Right Thing, Customer Success, Employee Success, and Speed – guide our mission. In 2021, we proudly became a public benefit corporation, committed to balancing the interests of our customers, employees, community, and investors.As a Work Anywhere organization, we empower our team to work in a way that suits them best, whether from home or in the office.Be a part of our mission to transform the life sciences industry and positively impact our customers, employees, and communities.The RoleWe are seeking a Senior Consultant with a strong background in system implementation and a passion for enhancing Clinical Operations data and document management processes for our clients. Our Clinical Suite offers the only comprehensive set of applications (eTMF, CTMS, Payments, Site Connect, Study Training) for managing clinical trials from site selection to study archival, specifically designed for Medical Device firms, Research Organizations, and Diagnostics Companies of all sizes. As part of our Professional Services team, you will engage with clients to understand their existing business processes, envision future state solutions, identify clinical needs, translate requirements into practical design, and develop global strategies for deploying our cloud-based solutions across their enterprises. This role is available for qualified candidates in the United States and is primarily remote, with a preference for those in the Eastern or Central Time Zones. Candidates near an airport who can meet travel requirements may also apply, regardless of their work location.

Join Whoop as a Senior Risk & Compliance Analyst, where you will play a crucial role in developing robust risk management strategies and ensuring compliance across our operations. You will collaborate with cross-functional teams to identify potential risks and implement effective solutions. Your expertise will directly contribute to maintaining our commitment to integrity and excellence.

Who We AreAt CarGurus (NASDAQ: CARG), we empower people by simplifying their journey to car ownership. Our story began with a passionate team of developers dedicated to bringing trust and transparency to the automotive marketplace. Over the years, our innovative approach and rapid market growth have positioned us as the largest and fastest-growing automotive marketplace, maintaining profitability for over 15 years.What We DoAs the automotive industry evolves, so do we. We are transforming the entire car buying experience online, assisting our customers from selling their old vehicles to financing, purchasing, and delivering new ones. Each month, millions of consumers visit CarGurus.com, and approximately 30,000 dealerships leverage our solutions. Our employees thrive in a people-first culture that promotes kindness, collaboration, and innovation, and provides the tools necessary for career advancement. Join us as we disrupt a trillion-dollar industry with fresh, diverse perspectives!Role Overview:As the Manager of Security Governance, Risk, and Compliance (GRC) within our Information Security team, you will play a pivotal role in the evolution of our established GRC function. You will not only maintain our program but also enhance our capabilities to ensure that security acts as a catalyst for our business success, converting complex regulatory demands into a competitive edge.Your strategic leadership will focus on high-standard execution while emphasizing Revenue Enablement, ensuring our security posture alleviates friction in the enterprise sales cycle and strengthens our reputation as a trusted partner.How You’ll Make a Difference:Lead an established team to elevate our GRC maturity, developing and refining our Integrated Management System (IMS) across standards such as ISO 27001, 27017, 27018, and SOC 2 Type II.Modernize our risk reporting through quantitative risk management, moving beyond traditional qualitative assessments to deliver real-time, data-driven insights and financial risk forecasts grounded in FAIR principles.Act as a key contributor on our AI Governance Committee, facilitating the secure implementation of AI/LLM features within our products and overseeing AI integration governance across our internal SaaS ecosystem in alignment with ISO 42001.Position GRC as a driver of revenue by enhancing our compliance and risk functions, ensuring our security trust posture promotes global growth and instills confidence in our stakeholders.

About PrileniaPrilenia is an innovative biopharmaceutical company dedicated to delivering groundbreaking therapies for individuals impacted by severe neurodegenerative diseases. Our global team is passionate and committed to advancing medical science, particularly through our development of pridopidine, an oral investigational neuroprotective treatment targeting ALS and Huntington’s disease (HD). Collaborating with Ferrer, we are poised to initiate critical late-stage trials that may lead to global approval for ALS and HD by the first half of 2026. Role OverviewWe are on the lookout for a motivated Regional Clinical Trial Manager to join our expanding team. This pivotal role involves overseeing and managing the operational activities of global pivotal trials in neurodegeneration. The successful candidate will possess extensive clinical research experience, particularly in clinical project management, and will have a proven track record of successfully managing global pivotal clinical trials for biotech sponsors. Experience with rare diseases, particularly ALS or HD, is highly desirable. This position requires a self-starter who can work independently across multiple projects while effectively collaborating within a matrix global team environment. The Regional Clinical Trial Manager will report directly to the SVP, Head of Clinical Operations.

Join our dynamic team at AECOM as a Bridge Inspection Team Leader / Structural Engineer. In this pivotal role, you will oversee bridge inspections, ensuring compliance with safety regulations and structural integrity. Your expertise will guide our project teams in delivering high-quality engineering solutions while fostering collaboration and innovation.

The Clinical Safety Specialist will collaborate with the clinical safety team to oversee the implementation of InterSystems' Clinical Safety Management Framework, enhancing the development and execution of our innovative healthcare products.Key ResponsibilitiesDeliver clinical safety assurance services across all InterSystems products.Modify and enhance InterSystems’ Clinical Safety Management Framework and Plan for optimal application.Serve as the primary escalation point for clinical safety concerns.Prepare Safety Reports based on issues escalated by customers, implementation, and support teams.Conduct thorough clinical safety assessments to evaluate clinical risks and promote patient safety improvements.Collaborate effectively within a multi-disciplinary team, including regional editions, implementation, and support.Facilitate clinical safety training sessions for internal and external stakeholders.Engage in activities of the Clinical Safety Group.Develop and maintain clinical safety documentation for regions and projects.Provide expert clinical safety and risk assessment guidance on customer sites.Share insights and experiences with customers and the InterSystems team pertaining to clinical safety best practices.Be ready to assume the role of Clinical Safety Officer or act as a Clinical signatory for InterSystems as required.

Join dstaff as a Senior Tax Manager and take your career to the next level. In this pivotal role, you will lead tax compliance and planning initiatives while ensuring the organization adheres to all relevant regulations. Your expertise will guide strategic decisions and optimize tax efficiency across various business operations.

Join AbbVie as a Senior Clinical Research Associate in Boston, where you will play a pivotal role in advancing our clinical research initiatives. You will be responsible for overseeing clinical trials, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to drive project success.