Job Description

Integrated Data Analytics and Reporting (IDAR)Senior Clinical Data Manager*(*Title may vary based on Region or Country requirements)Job Location - Mumbai/Hyderabad/Bangalore (Hybrid)Position Summary:The Senior Data Manager is a professional individual contributor role at experienced level that provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity trials. The Senior Data Manager makes recommendations and decisions that have an impact on processes, timing, and structure for trials and assignments with minimal direction from manager or Data Management Leader (DML). This position also makes recommendations for processes, timing, structure, and resources at a program level. Work is received in broad terms, reviewed during major deliverables, and the amount of instruction is limited. Work is reviewed with the Data Management Leaders, or the immediate manager as needed.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:

\xc3\x98 Gather and/or review content and integration requirements for eCRF and other data collection tools.\xc3\x98 Establish conventions and quality expectations for clinical data.\xc3\x98 Establish expectations for dataset content and structure.\xc3\x98 Set timelines and follow-up regularly to monitor delivery of all data management milestones.

• Ensure accurate review of related clinical data management documents as well as compliance with regulatory guidelines and documentation requirements.

• Ensure real-time inspection readiness of all DM deliverables for the trial; participate in Regulatory Agency and J&J internal audits as necessary.

• Lead the planning and tracking of content, format, quality, and timing of applicable data management deliverables. Ensure deliverables are on time.

• Take a leadership role to obtain and share best practices with internal partners. Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.

• Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency.

• Identify and participate in process, system, and tool improvement initiatives.

• Lead others in implementing process, system, and tool improvement initiatives.

This position may be specialized into the following roles based on business needs: Clinical Data Manager (CDM)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.

• Take a leadership role in collaborating 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. 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. 10 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry.

• Experience in clinical drug development within the pharmaceutical or related industry.

• Experience working with cross functional stakeholders and teams.

• Strong written and verbal communications skills (in English).

• Team leadership experience.

• Strong 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.

• Knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.).

• In-depth knowledge of project management and techniques and knowledge of team management principles.

• Experience in clinical data review or significant experience with clinical data review and knowledge of medical terminology

Other:

• Approx.

eQuest