Overview
Analyst II, Global Data Manager — High Wycombe, United Kingdom (Hybrid: 3 days per week onsite).
At Johnson & Johnson, we are seeking talent to join our Clinical Data Standards team. The Analyst II Data Manager provides oversight for data management activities across multiple trials of low to moderate complexity or a single high-complexity trial, making recommendations and executing critical data management tasks under guidance with increasing autonomy.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Learn more at https://www.jnj.com/innovative-medicine
You Will Be Responsible For
* Taking a leadership role with external suppliers, trial customers, and other internal/external partners to establish, align, and confirm data management expectations for assigned trial(s).
* Gathering and reviewing content and integration requirements for eCRF and other data collection tools.
* Establishing conventions and quality expectations for clinical data.
* Establishing expectations for dataset content and structure.
* Setting timelines and following up regularly to monitor the delivery of all data management milestones.
* Reviewing clinical data management documents (including submission packages) ensuring quality, scientific content, organization, clarity, accuracy, format, and consistency.
* Ensuring compliance with regulatory guidelines and the documentation matrix.
* Ensuring real-time inspection readiness of all DM deliverables and participating in regulatory agency and J&J internal audits as necessary.
* Planning and tracking content, format, quality, and timing of applicable data management deliverables; ensuring on-time delivery.
* Leading the assigned clinical working group(s) to ensure DM and TA trial needs and deliverables are achieved.
* Creating key functional plans (e.g., study Integrated Review Plan) with appropriate quality and scientific content.
* Identifying lessons learned, best practices, and frequently asked questions at the trial level.
* Participating in process, system, and tool improvement initiatives.
* Performing trial-level oversight controls and/or executing data management activities per applicable procedures, with DML direction.
Principal Relationships
* Reports to a people manager within Data Management.
* Functional contacts within IDAR and J&J Innovative Medicine include leaders across Data Management, Central Monitoring, Clinical Data Standards, Regulatory Medical Writing, and related support organizations.
* External contacts include external partners and suppliers, CRO management and vendor liaisons, industry peers, and working groups.
Qualifications/ Requirements
* Bachelor's degree (e.g., BS, BA) or equivalent professional experience; preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g., Masters, PhD).
* Minimum 2 years' experience in Pharmaceutical, CRO, Biotech, or related field.
* Experience in clinical drug development within the pharmaceutical industry or related field.
* Experience working with cross-functional stakeholders and teams.
* Strong written and verbal communications skills (in English).
Preferred
* Team leadership experience with oversight and delegation skills while contributing as an individual contributor.
* Clinical data management experience and knowledge of clinical trial protocols.
* Knowledge of current clinical drug development processes and international guidelines on data management of clinical trials.
* Knowledge of technology platforms and systems to capture/process data and understanding of data privacy rules related to clinical data exchange.
* Approx. 10% travel (domestic or international) may be required.
Benefits
We offer a competitive salary and extensive benefits package. Our health and well-being focus supports a flexible working environment with a commitment to work-life balance. Career development opportunities are available for those who want to grow within the organization.
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.
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