Sr Corporate Counsel, Data Privacy

INC Research Inc Morrisville , NC 27560

Posted 3 months ago

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients' lives around the world.

JOB SUMMARY

Responsible for supporting the development, implementation and maintenance of the Company's Global Privacy and Data Protection program with the goal of ensuring compliance with all applicable laws and regulations globally, with a focus on the Americas region. The position will interact with departments and business units across the Company.

JOB RESPONSIBILITIES

Supporting the Global Privacy Officer:

  • Develop, implement and maintain the Company's Privacy and Data Protection policies, processes and procedures.

  • Monitor changes in Privacy and Data Protection laws and regulations globally to ensure Company adaptation and compliance, including required country registrations.

  • Provide legal advice regarding the implications of new privacy and data protection laws and regulations globally that impact the Company`s business.

  • Identify and implement data privacy best practices.

  • Provide strategic guidance to Departments/Business Units in the design and evaluation of Privacy and Data Protection related tools and projects (e.g., privacy-by-design).

  • Establish a mechanism to track access and retention of protected health information maintained by the Company.

  • Develop, implement and deliver Privacy and Data Protection communications and training.

  • Collaborate with Information Security to ensure alignment between Cyber Security and Privacy and Data Protection practices. Oversee conduct of data protection impact assessments and support such assessments.

  • Collaborate with the contracting functions on the drafting, review and negotiation of Privacy and Data Protection matters related to customer and third party contracts (e.g., data transfer agreements, privacy notices/policies).

  • In coordination with the Global Privacy Officer and Data Protection Officer, assist with regulatory authorities, including the FTC, OCR, Canada's OPC, and privacy regulators in Latin America, for matters relating to privacy and data protection.

  • Implement and oversee a process for receiving, documenting, tracking, investigating and acting on internal and external Privacy and Data Protection requests (e.g., changes to/deletion of information from systems) and complaints. Investigate complaints about breaches of applicable regulations. Maintain a log of incidents of remedial actions.

  • In collaboration with other Company departments (e.g., Information Security, Corporate Quality and Vendor Management), establish an internal and external Privacy and Data Protection monitoring and audit program.

  • Manage the collection, analysis and reporting of Privacy and Data Protection program data and metrics for continuous process improvement.

  • Participate in client meetings, customer audits and regulatory inspections for questions related to Privacy and Data Protection.

  • Participate in data security incident responses affecting the Company.

  • Coordinate cross-functionally to provide data privacy support and guidance with respect to the Company's records management program.

  • Support the development and delivery of data protection representative services to contracted customers.

  • Role may be assigned to manage Privacy and Data Protection professionals.

  • Perform other work-related duties as assigned. Minimal travel may be required (up to 25%).

QUALIFICATION REQUIREMENTS

  • Completion of law school with a J.D. or L.L.B. degree and admission to the bar and in good standing in at least one jurisdiction in the United States required.

  • 8 years of legal experience as a practicing attorney, with at least 3 of those years advising on global data protection/ privacy laws and requirements.

  • Experience as in-house counsel strongly preferred.

  • Experience with U.S. and international privacy program development and management preferred, with particular emphasis in the healthcare and clinical research environments.

  • Knowledge of US and international privacy and data protection laws, regulations and best practices required (e.g., HIPAA, CAN-SPAM, CCPA, TCPA, PIPEDA, CASL, Privacy Shield, and GDPR).

  • Innovative, forward-thinking and results-oriented with a passion to solve complex problems in a creative and pragmatic way and to translate laws and regulations into actionable policies and procedures that enable business objectives.

  • Demonstrated ability to influence and drive internal and external stakeholders to a decision in a matrixed corporate environment.

  • Ability to work independently, meet tight deadlines and work effectively in a multi-functional, international team environment.

  • Excellent interpersonal skills and work ethic. Strong communication and writing skills.

  • IAPP certification(s) (CIPP/E, CIPP/US, CIPM) preferred.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

#LI-CT1


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Sr Clinical Data Associate (Cda) Morrisville NC

INC Research Inc

Posted 3 days ago

VIEW JOBS 8/19/2019 12:00:00 AM 2019-11-17T00:00 JOB SUMMARY This position is responsible for leading other Clinical Data Associates (CDA) in all data management activities, providing support and may function as a backup for the Project Data Manager (PDM) on a study as required for global clinical trials. JOB RESPONSIBILITIES * Maintains awareness of the pertinent elements of contract and scope of work for assigned project(s) and communicates status updates to the Project Manager (PM) and/or Biometrics Project Manager (BPM) as necessary. * Reviews and adheres to the requirements of study-specific DMP for assigned project(s) and updates as required. * Creates and enters test data for User Acceptance Testing (UAT) * Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study and Targeted Source Data Verification (SDV) configuration and matrices. * Receives and enters lab normal ranges. * Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets. * Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections or other global rulings permitted in cases where queries are not required, per the DVS and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries and re-queries where appropriate. * For paper studies, takes receipt of, and reviews, Data Clarification Forms (DCFs) that have been answered by sites and where appropriate, edits the CRF database accordingly. * For paper studies, performs internal QC checks via listing output from database against CRFs and DCFs. Serves as QC Coordinator for paper studies. * For paper studies, ensures all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects. * For EDC studies, performs DM quality review and/or other internal QC checks as required per applicable Electronic Data Capture (EDC) systems. * Participates/Leads in internal meetings. * Attends in-process review meetings. * Participates in internal/external audits as required. * Files documentation in the Data Management Study File (DMSF). * Maintains proficiency in Data Management systems and processes through regular trainings (CDA Knowledge College) * Performs SAS mapping QC whereby discrepancies are noted on the SAS mapping test logs. * Oversees the work of other CDAs as required. This may involve on-the-job training, review of work, as well as ensuring the quality of work performed. * Ensures that data from external databases/datasets such as central and/or local laboratory data, electronic diary data, pharmacokinetic (PK) data, or Interactive Response Technology (IRT) are consistent with data in the clinical database. Uses the specified process to document and query any such discrepancies found with the appropriate party * Completes tasks within timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates to project team and management accurate estimates on time to complete tasks, availability to take on new assignments and resourcing conflicts. Minimizes rework by following study instructions, seeking understanding of assignments prior to performing task and anticipating the effect changes may have on data when issuing and resolving queries. * Performs Serious Adverse Event (SAE) reconciliations. * Liaises with other groups such as Clinical Programming (CP), Biostatistics and Clinical Operations. * Creates ad-hoc data cleaning reports used to determine if a validated listing is required including creation of the specification for the validated listing (updates DVS with the listing requirements). * Perform post-migration testing on screens, edit checks, matrices and role changes as required. * Participates in customer and third party meetings distributing relevant information in advance, ensures minutes are promptly and accurately distributed to internal team for review and subsequent edits are applied in order to maintain established currency for sponsor distribution. * Reviews database design specifications (including configuration, data structures, annotated CRFs). * Designs and/or reviews CRF/eCRF including eCRF visit structure co-coordinating with team members responsible for the associated database design. * Provides input into the Data Validation Specification (DVS) including creation of edit checks for assigned forms including any post-production updates to the DVS and listings under guidance. * BA/BS degree in the biological sciences or related disciplines in the natural science/health care field. * Experience with DM practices and relational database management software systems preferred. * Oracle Clinical, Rave, or Inform systems preferred. Knowledge of clinical data, and ICH/Good Clinical Practices. Knowledge of medical terminology preferred. * Proficiency in navigating MS Windows, as well as use of MS Word, Excel, and email applications. Excellent speed and accuracy of keyboard skills. * Work experience in clinical research, drug development, data management, or other healthcare environment preferred. * Familiarity with medical terminology * Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade * Good organizational, planning, and time management skills preferred. Ability to multitask under tight deadlines while providing attention to detail. Ability to be flexible and adapt to change. Ability to work independently as well as part of a multi-disciplinary team. * Ability to perform a leadership functions in DM including effective mentoring skills, and the ability to deal effectively with sponsors and internal customers. * Responsible for performing activities that are in compliance with applicable Corporate Business Practices, Standard Operating Procedures and Working Instructions and performing other duties as assigned by management. Minimal travel may be required (up to 25%). INC Research Inc Morrisville NC

Sr Corporate Counsel, Data Privacy

INC Research Inc