Analyst II, Global Data Manager
- High Wycombe, Buckinghamshire
- Permanent
- Full-time
- 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.
- 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.
- 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 2 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).
- 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