Analyst II, Clinical Data Manager

at  Johnson Johnson

The Analyst II Data Manager is a professional individual contributor role at junior level that provides oversight and accountability and/or executes data management activities and/or performs scientific data review for more than one trial of low to moderate complexity or for one high complexity trial. The Analyst II Data Manager makes recommendations and influences decisions for specific trials or assignments. This position analyzes and provides input into decisions with direction from manager or Data Management Leader (DML). Work is received in broad terms. Work is reviewed on an ongoing basis with Data Management Leader and the amount of instruction is limited.

Principal Responsibilities:

• Take 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: o Gather and/or review content and integration requirements for eCRF and other data collection tools. o Establish conventions and quality expectations for clinical data. o Establish expectations for dataset content and structure. o Set timelines and follow-up regularly to monitor delivery of all data management milestones.
• Review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensure compliance with regulatory guidelines and the documentation matrix.
• Ensure real-time inspection readiness of all DM deliverables for the trial and participate in regulatory agency and J&J internal audits as necessary.
• Plan and track content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.
• Take a leadership role with the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are achieved.
• Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
• Identify and communicate lessons learned, best practices, and frequently asked q questions at the trial level.
• Identify and participate in process, system, and tool improvement initiatives

he Analyst II Data Manager is a professional individual contributor role at junior level that provides oversight and accountability and/or executes data management activities and/or performs scientific data review for more than one trial of low to moderate complexity or for one high comp lexity trial. The Analyst II Data Manager makes recommendations and influences decisions for specific trials or assignments. This position analyzes and provides input into decisions with direction from manager or Data Management Leader (DML). Work is recei ved in broad terms. Work is reviewed on an ongoing basis with Data Management Leader and the amount of instruction is limited. Principal Responsibilities: • Take 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: o Gather and/or review content and integration requirements for eCRF and other data collection tools. o Establish conventions and quality expectations for clinical data. o Establish expectations for dataset content and structure. o Set timelines and follow- up regularly to monitor delivery of all data management milestones.• Review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensure compliance with regulatory guidelines and the documentation matrix.• Ensure real- time inspection readiness of all DM deliverables for the trial and participate in regulatory agency and J&J internal audits as necessary.• Plan and track content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.• Take a leadership role with the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are achieved.• Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.• Identify and communicate lessons learned, best practices, and frequently asked questions at the trial level.• Identify and participate in process, system, and tool improvement initiatives.

QUALIFICATIONS

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.
Education and Experience Requirements:

Required

• 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.,

Master, PhD).

• Approx. 2 years of 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).

• Take 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: o Gather and/or review content and integration requirements for eCRF and other data collection tools. o Establish conventions and quality expectations for clinical data. o Establish expectations for dataset content and structure. o Set timelines and follow-up regularly to monitor delivery of all data management milestones.
• Review clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency. Ensure compliance with regulatory guidelines and the documentation matrix.
• Ensure real-time inspection readiness of all DM deliverables for the trial and participate in regulatory agency and J&J internal audits as necessary.
• Plan and track content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.
• Take a leadership role with the assigned clinical working group(s) to ensure that DM and TA trial needs and deliverables are achieved.
• Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.
• Identify and communicate lessons learned, best practices, and frequently asked q questions at the trial level.
• Identify and participate in process, system, and tool improvement initiative