Endpoint Clinical

Sr. Manager Quality Trust & Compliance (Privacy Compliance)

United States

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Life Sciences, Pharmaceuticals, eClinical TechnologyIndustries

Requirements

Candidates must possess a Bachelor's degree in Information Security, Data Governance, Computer Systems, Life Sciences, or a related field. A minimum of 7 years of experience in privacy, data protection, or compliance, ideally within the life sciences, healthcare, or SaaS technology sectors, is required. Demonstrated experience in conducting audits, performing privacy impact assessments, and establishing enterprise-wide privacy programs is essential. The role also requires the ability to thrive in cross-functional, fast-paced, global environments with strong stakeholder engagement. Prior experience as a Risk Protection Officer, DPO, or with DPO responsibilities is preferred. A deep understanding of GDPR, HIPAA, CCPA/CPRA, 21 CFR Part 11, and other global privacy regulations is necessary. Familiarity with clinical trial operations and regulatory technology solutions, as well as an understanding of cloud security and vendor risk related to privacy compliance, are preferred.

Responsibilities

The Sr. Manager Quality Trust & Compliance will lead and operationalize privacy programs across global eClinical technology landscapes, serving as a key liaison between Quality, Global Privacy Office, IT, and Product & Engineering teams. Responsibilities include partnering with Legal/Global Privacy Office and Quality, Trust & Compliance to operationalize privacy compliance frameworks, developing and maintaining privacy policies, standards, and procedures, and driving the adoption of privacy-by-design principles. The role involves planning, executing, and overseeing internal privacy audits, assessments, and control evaluations, conducting privacy impact assessments (PIAs), data protection impact assessments (DPIAs), and risk analyses. Additionally, the manager will support the Data Protection Officer (DPO) by managing communication with supervisory authorities and data subjects, maintaining records of data processing activities (RoPAs), and ensuring timely handling of privacy rights requests. The position also requires advising senior management on global privacy regulations, leading privacy program integration across various departments, guiding teams through regulatory readiness, and collaborating on incident response and breach notifications. Furthermore, the role includes developing and delivering training and awareness programs on privacy topics to foster a culture of compliance, ethics, and trust.

Skills

Privacy Compliance
Data Privacy
Data Protection
Privacy Audits
Risk Management
Privacy Impact Assessments (PIAs)
Data Protection Impact Assessments (DPIAs)
Privacy-by-Design
Policy Development
Compliance Frameworks
Quality Assurance
Global Regulatory Requirements

Endpoint Clinical

Provides interactive response technology for clinical trials

About Endpoint Clinical

Endpoint Clinical provides interactive response technology (IRT) systems designed for clinical trials. Their systems assist with various trial processes such as managing drug supplies, randomizing patients, and scheduling visits. These systems are user-friendly and cater to clients in the life sciences sector, including pharmaceutical and biotechnology companies. Endpoint Clinical differentiates itself by focusing on ease of use and integration with other clinical trial management systems, ensuring that clients can streamline their processes and maintain regulatory compliance. The company's goal is to enhance the efficiency and transparency of clinical trials, allowing sponsors to conduct their research more effectively.

San Francisco, CaliforniaHeadquarters
2009Year Founded
$1.7MTotal Funding
DEBTCompany Stage
Enterprise Software, HealthcareIndustries
201-500Employees

Benefits

Remote Work Options

Risks

Emerging IRT providers with cost-effective solutions threaten Endpoint Clinical's market share.
Rapid AI advancements may outpace Endpoint Clinical's current technology offerings.
Decentralized trials could reduce demand for traditional IRT systems, impacting Endpoint's model.

Differentiation

Endpoint Clinical offers user-friendly IRT systems for clinical trial management.
The company specializes in drug supply management, patient randomization, and visit scheduling.
Endpoint Clinical collaborates with THREAD and Berlinger for integrated clinical trial solutions.

Upsides

Increased adoption of DCTs boosts demand for flexible IRT systems like Endpoint Clinical's.
AI integration in clinical trials offers Endpoint opportunities for advanced analytics.
Personalized medicine trends require sophisticated IRT solutions, benefiting Endpoint Clinical.

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