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Job Function
Data Analytics & Computational Sciences
Job Sub Function
Clinical Data Management
Job Category
Professional
All Job Posting Locations:
Bangalore, Karnataka, India, Hyderabad, Andhra Pradesh, India, Mumbai, Maharashtra, India
Job Description
Integrated Data Analytics and Reporting (IDAR)
Analyst II Clinical Data Manager*
(*Title may vary based on Region or Country requirements)
Position Summary
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:
- Gather and/or review content and integration requirements for eCRF and other data
collection tools.
- Establish conventions and quality expectations for clinical data.
- Establish expectations for dataset content and structure.
- 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.
Clinical Data Manager Role-specific Responsibilities
- Perform (complex) scientific study data review and management of CDM, Study Responsible
Scientist (SRS, and Study Responsible Physician related queries in EDC system. Involvement
in other clinical data review activities (e.g., Coding, SAE reconciliation) is possible.
- Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and
deliverables are achieved.
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.
Required
Education and Experience 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.,
Master, PhD).
- Approx. 5+ 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).
Preferred
- Team leadership experience.
- 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.
Other
Approx. <10% travel (domestic or international) may be required.
