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Analyst II, Global Data Manager

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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https: //www.jnj.com/innovative-medicine

We are searching for the best talent for an Analyst II Data Manager in our Clinical Data Standards team, located in High Wycombe, United Kingdom (Hybrid: 3 days per week onsite). In this role, you will provide oversight and accountability for data management activities across multiple trials of low to moderate complexity or for a single high-complexity trial. The Analyst II Data Manager makes recommendations and influences decisions for specific trials or assignments while executing critical data management tasks and performing scientific data reviews. You will analyse data and make informed recommendations under the guidance of your manager or the Data Management Leader (DML). Your work will be received in broad terms, with oversight from the DML on an ongoing basis, and the amount of instruction will be limited, allowing for autonomy.

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 and/or clinical data management expectations to the business for assigned trial(s) to include but not limited to:
• Gathering and/or 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 package) ensuring appropriate 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 for the trial 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 deliverables are on time.
• Taking a leadership role with the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are achieved.
• Creating key functional plans (e.g., study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
• Identifying and communicating lessons learned, best practices, and frequently asked questions at the trial level.
• Identifying and 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 into people manager position within functional area (e.g., Data Management Leader).
• Functional contacts within IDAR include but not limited to: Leaders and/or leads in Data Management and Central Monitoring, Clinical and Statistical Programming, Clinical Data Standards, Regulatory Medical Writing, IDAR Therapeutic Area Lead, and system support organizations.
• Functional Contacts within J& J Innovative Medicine (as collaborator or peer) include but not limited to: Global Program Leaders, Global Trial Leaders, Biostatisticians, Clinical Teams, Procurement, Finance, Legal, Global Privacy, Regulatory, Strategic Partnerships, Human Resources and Project Coordinators.
• External contacts include but not limited to: 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 is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g., Masters, PhD).
• Minimum 5 years' experience in Pharmaceutical, CRO or Biotech industry or related field or industry!
• Experience in clinical drug development within the pharmaceutical industry or related industry.
• Experience working with cross functional stakeholders and teams.
• Strong written and verbal communications skills (in English).

Preferred

• Team leadership experience showcasing effective oversight and delegation skills to guide and support team members while contributing as an individual contributor.
• Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols.
• In-depth knowledge of current clinical drug development processes.
• In-depth knowledge of applicable international guidelines regarding data management of clinical trials.
• Knowledge of technology platforms and systems to capture and process data as well as understanding of data privacy rules in relation to clinical data exchange.
• Approx. < 10% travel (domestic or international) may be required

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 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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