Document Anonymization Manager
Bengaluru, India
6d ago

Site Name : Bengaluru Luxor North Tower

Posted Date : Jul 20 2022

Is there any greater challenge than getting ahead of disease?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution.

  • Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022 : New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science;
  • and a new world-leading consumer healthcare company of loved and trusted brands.

  • With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together all with the clear ambition of delivering human health impact;
  • stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

    Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture.

  • A culture that is ambitious for patients so we deliver what matters better and faster; accountable for impact with clear ownership of goals and support to succeed;
  • and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey.

    Join our challenge to get Ahead Together.

    Rational e : -

    As part of the GSK Future Ready program, the R&D Bioethics, Risk Management and CMOs office was created with direct reporting into CMO to achieve appropriate external engagement, ensure highest standards of Medical governance and comply with regulations in multiple areas of intense focus and scrutiny such as Research practices, Data disclosure and Non-promotional engagement.

    Within the Clinical Transparency Team, the Document Anonymisation team provides a critical role in the preparation of anonymised clinical documents to meet GSK’s clinical document disclosure obligations.

    These include regulatory (e.g. EMA Policies 0070 and 0043, Health Canada, NIH), external data sharing and policy requirements.

    The Manager, Document Anonymisation is required to prepare clinical documents for anonymisation and to ensure that all personal and company confidential information is anonymised or removed in adherence with GSK written standards prior to disclosure.

    The location of the job is being changed, in line with the business strategy of the R&D Bioethics, Risk Management and CMOs team.

    Job Purpose

    The Manager, Document Anonymisation provides a critical role in the preparation of anonymised clinical documents to meet GSK’s clinical document disclosure obligations.

    These include regulatory (e.g. EMA Policies 0070 and 0043, Health Canada, NIH), external data sharing and policy requirements.

    The Manager, Document Anonymisation is required to prepare clinical documents for anonymisation and to ensure that all personal and company confidential information is anonymised or removed in adherence with GSK written standards prior to disclosure.

    The role is required to provide support to all therapy areas in GSK R&D who prepare anonymised documents. The job-holder is required to interact with a diverse group of global functions, including other groups within Medical Governance and Data Disclosure, study teams in clinical, Epi and Value Evidence Outcomes, document anonymisation vendor(s), off-shore service providers, publishing and regulatory teams.

    Key Responsibilities : -

    1. Manage the daily operations of anonymizing clinical documents. Establish priorities for anonymization and data verification and ensure the proper controls are in place and review the outputs of anonymization to ensure quality of information for external researchers.

    2. Have overall accountability of the document anonymization capability, driving development, competence, overall strategy both internally and externally.

    3. Maintain a strong relationship with internal business partners and act as a key contact supporting SHARE and Statistics and Programming, Medical and Regulatory Policy, Therapeutic areas and other relevant functions for both current and historical studies.

    4. Create a community of practice to establish greater cross communication between central, medical policy and statistics and programming groups.

    Contribute to industry and regulatory standards for data re-use and anonymization.

    5. Be part of the governance model for the processes / systems that impact delivery of Transparency commitments.

    6. Work closely with the Director Clinical Data Transparency and Director of Data Sharing; align GSK processes to impending disclosure regulations.

    Act as a subject matter expert on the regulatory requirements for document anonymization, including EMA Policy 070 and Health Canada

    7. Manage business relationships with external vendors to ensure simple and efficient models for anonymizing clinical documents, and for delivering quality, on time and in line with GSK expectations.

    8. Serve as the Business Capability Lead / Subject Matter Expert for the document anonymization capabilities, including system / technology, regulatory inspection / internal audit.

    Proactively devise process improvements based on feedback from clinical groups and governance bodies to ensure GSK meet our commitments.

    Proactively meet with teams authoring clinical documents and propose working practices to minimize the PI and CCI contained within clinical documents

    9. Ensure proper documentation and oversight of all business processes, standard procedures and work instructions related to document anonymization capability ensuring compliance with regulatory requirements

    10. Monitor new technologies and external trends to ensure GSK is leveraging the best of what is available.

    Knowledge / Education Required : -

    Minimum Level of Education Required - Master’s Degree

    Area of Specialization - Life sciences or Medical background or equivalent with expertise in a particular area of medicine or clinical science.

    Knowledge and awareness of statistics and programming, analysing clinical trial data, data anonymization and or de-identification.

    Why is it required - Poor protection of personal identifiable information and data disclosure will impact GSK’s decision-making ability, productivity and credibility if the trustworthiness of these data in processes such as data sharing and data re-use is questioned.

    GSK’s commitment to share data is an external commitment; data is often shared with scientific thought leaders and external scientific critics of the pharmaceutical industry sharing incorrect or inaccurate data could come with high reputational risks.

    Previous Experience Required : -

    Minimum Level of Job-Related Experience Required-

  • At least 6 years of experience in scientific writing, regulatory writing, publications writing or equivalent.
  • Experience in Pharmaceutical company environment and specifically in matrix organization
  • Experience in managing clinical trial (study, data, or system / technology) activities.
  • Good understanding of clinical trial lifecycle, clinical trial metadata i.e. information about the trials , clinical trial data i.
  • e. observed data collected as part of the trial , clinical documents.

    Why is this level of experience required -

    To understand and interpret regulations and implications for clinical trial transparency requirements and clinical development processes as well as disclosure systems and interfaces with GSK clinical trial tracking / management systems.

    Job-Related Experience sections above that are required for the job : -

  • Good understanding of R&D and the clinical development process to enable understanding of anonymization related activities, manage risks and, where required, develop novel solutions and processes.
  • Good overview and understanding of end to end study process and data flow; in-depth knowledge of patient data a recognized expert.
  • Ability to bridge the communications gap between scientific / medical and non-scientific organizations. Ability to communicate the importance of relevant technical or process solutions to business problems.
  • Provide personalized communications with reasons and rationale, context and relevance of the thinking. Describe anonymization in a way that can be understood by the Business.

  • Excellent verbal and written communication skills.
  • Ability to work with a high degree of independence.
  • Excellent attention to detail.
  • Good teamwork and interpersonal skills with demonstrated ability to interact effectively across boundaries with other global functions using influencing and relationship building skills.
  • Ability to effectively manage conflicting demands in a high pressure, constantly changing environment and still achieve timely delivery
  • Awareness of medical writing, publishing and regulatory processes and associated deliverables. Experience of reviewing clinical documents is an advantage.
  • Knowledge & Application : -

    o Knowledge of EMA-POL-0070, Data privacy, and guidelines / regulations governing anonymization of personal data.

    o Knowledge of GCP / ICH guidelines and regulations governing clinical trial disclosure (e.g. FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation)

    o Knowledge of PhRMA / EFPIA principles of clinical trial disclosure, and related best practices

    o Experience with Clinical Trial Disclosure software solution(s)

    o Advanced knowledge of International Committee for Harmonization (ICH) / Good Clinical Practice (GCP) regulations

    o In-depth knowledge and experience of guidelines / corporate policies / legal requirements governing public disclosure.

    o Demonstrated knowledge and understanding of structure and content of study reports and protocols.

    o Strong knowledge and skills in project management.

    Skills : -

    o Effective oral and written communication skills to influence, inform, or guide others

    o Excellent leadership skills, promoting, motivating and empowering of others in order to accomplish individual, team and organizational objectives

    o Ability to work with global teams in different geographies with a diverse set of perspectives in different regulatory contexts

    o Able to set and manage priorities in a global environment

    o Ability to analyze and interpret complex issues and propose innovative solutions

    o Ability to effectively respond to regulatory trends, internal audits, inspection activities including root cause analysis / Corrective Action / Preventive Action (CAPA) plans for any findings.

    o Experience working in a matrix environment.

    Application of Knowledge : -

    This role requires a thorough knowledge of de-identification and anonymization techniques that can be applied to individual patient data (IPD) in order to fulfil transparency, disclosure and research requests while safeguarding the privacy of individuals (e.

    g., participants and company staff). This role also requires domain knowledge (e.g., Clinical Statistics, Data Standards, Study Excellence and Capability Development, and Clinical Data Transparency) as well as strong communication, influencing, analysis and change management skills to scope, prioritises, plan and drive activities to deliver a clear, strategic vision of anonymization relating to clinical studies and disclosure for R&D.

    Problem Solving & Innovation : -

  • Proactively identify potential project problems / issues and develop and negotiate recommendations for resolution
  • Project and change management, and an understanding of policy requirements, external regulations and anonymisation standards.
  • Excellent interpersonal skills and an established broad network in order to engage both sponsors and key stakeholders, and to access in-depth expertise amongst staff within the GSK business and external to GSK.
  • This role will be operating in a complex working environment with multiple stakeholders, competing priorities and limited resources.
  • This will require the jobholder to demonstrate vision and drive a strategy that focuses on building anonymization capabilities using knowledge and judgment to ensure that optimal solutions are developed on time, with quality and within budget.

    Interaction : -

  • Interactions within the team Ensure adequate communication at the level of the team to ensure alignment and appropriate interaction between all functions of the teamsEnsure adequate integration of all types of disclosure requirements for the whole company
  • Interaction and influence within GSK at different levels of the organization : Project and Study Delivery teams (e.g. : Clinicians, Regulatory teams, Science writers )Risk Management, Quality, Compliance teamsIT and Technical support teams
  • Interactions outside of GSK Industry groups when driving influencing anonymization strategy.With service providers (outsourced activities)
  • Multi-Cultural Requirements : -

    This global role will work with stakeholders across therapy areas and IT groups at all levels. It must ensure the evolving demands of this extremely complex area are understood, agreed and acted upon with the appropriate level of urgency across all impacted divisions.

    The role will be truly global working with departments across RDCs, and cross-departments. Ability to work across cultures and time zones and build effective virtual teams is essential.

    Additionally, the corporate cultures of external contractors and providers must also be managed.

    GSK Policies are applicable worldwide and the role with have to interact with multiple culture and multiple mindset population to ensure common understanding and implementation of the standards.

    Impact : -

    Sharing Patient Level Data is a key component of Transparency and Building Trust, timely and consistent availability of patient level data per policy regardless of study outcomes is critical to the success of this initiative.

    The role plays a vital role in monitoring governance and compliance of SHARE and the delivery of appropriate data to external researchers.

    Without appropriate compliance and escalation, GSK is vulnerable to legal and reputation risk. The role holder must ensure that all studies in scope for sharing are anonymized to the most appropriate policies and regulatory standards.

    Major impact within the Clinical Trial Transparency group as it will have an impact on GSK’s external reputation.

    At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

  • LI-GSK
  • Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible.

    Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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