Manager Clinical Data Transparency, Clinical Registry - 2406199989W

Description

Manager Clinical Data Transparency, Clinical Registry

Location: High Wycombe, United Kingdom

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/

We have a new opportunity within our Integrated Data Analytics and Reporting (IDAR) team, Innovative Medicine, for a Manager Clinical Data Transparency, Clinical Registry located within commutable distance of our site in High Wycombe, UK.

The Manager, Clinical Data Transparency, serves as an individual contributor and emerging subject matter expert in Data Transparency (DT), working independently with minimal supervision. This role involves consulting on projects, programs, and processes that span multiple related areas to support the organisation’s overall DT strategy. The Manager applies in-depth DT knowledge to maintain and improve best-in-class policies, procedures, and plans for clinical registries, data and document anonymisation, data sharing, and plain language summaries.

Are you ready to join our team? Then please read further!

Principal Responsibilities:

• Acts as a top-level specialist to establish programs and new initiatives for the organisation to advance DT priorities.

• Manages projects, programs or processes for the DT area.

• Understands, communicates and ensures adherence to DT and data anonymisation policies.

• Governs DT capabilities and roadmap, including strategic priorities for DT.

• Reviews critical quality issues to drive root cause assessment and mitigation planning.

• Studies regulatory and industry trends in data transparency and anonymisation to integrate trends and best practices.

• Coaches and trains junior colleagues in techniques, processes and responsibilities.

• Integrates J&J Credo and Leadership Imperatives into team goals and decision-making.

Manager Clinical Data Transparency, Clinical Registry

• Is the owner of the overall integrity of the compliance management system for country specific clinical trial registries (including EU-PASS and the Pan-African CTR) and ensures consistent use by the clinical registry, vendor’s disclosure associates and business partners.

• Is subject matter expert on local clinical trial registries, and as such provides expertise in discussions and projects with internal and external business partners

• Is responsible for the country specific clinical trial registry process

• Writes, trains and maintains job aids for local clinical trial registries where needed in addition to the company SOPs.

• Ensures service level agreements between the clinical registry and countries and business partners are made

• Reports and analyses metrics on the country specific registry process

• Oversees vendors for outsourced activities

• Assigns the country portfolio to the CRG

• Assigns countries to clinical registry administrators

• Manages the process and deliverables through individual and team meetings and ensure consistency and continuation of process and policy

• May manage one of the other key disclosure processes

• In joint meetings with the other Clinical Registry Managers develops a good understanding of all registry activities and can provide guidance and backup in the team

Principal Relationships:

Internal: Align, collaborate, advise, and share best practices with other functions and teams in Therapeutic Areas, Global Development, Regulatory Affairs, Data Sciences, Legal, Global Privacy, Data Transparency and others as needed.

External: Interact and collaborate with vendors.

Act as J&J representative for defining process standards and sharing practices with industry counterparts and working groups, as required.

Qualifications

Education and Experience Requirements:

• A bachelor’s degree in a scientific, technology or healthcare discipline, or equivalent experience

• At least 5 years of relevant pharmaceutical/scientific experience in a related discipline; e.g. medical writing, data management, biostatistics, clinical programming, clinical trials operations is required!

• Excellent understanding of at least one of the following: regulatory clinical trial disclosure requirements, translation of scientific content for a lay audience, anonymisation of clinical data and documents, data sharing.

• Demonstrated written and verbal communications skills

• Demonstrated customer focus and solution-oriented experience

• Demonstrated interpersonal skills to build relationships with internal and external business partners

• Demonstrated leadership on cross-functional projects within a matrix organisation

• Demonstrated leadership in decision making and problem solving

Benefits:

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organization.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will be considered for employment without regard to any other characteristic protected by law.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform important job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-United Kingdom-England-High Wycombe

Organization Janssen Cilag Ltd. (7360)

Job Function Data Governance & Policy

Req ID: 2406199989W