Analyst Ii Global Data Manager

At Johnson Johnson we believe health is everything Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity Learn more at https www jnj com Job Function Data Analytics Computational Sciences Job Sub Function Clinical Data Management Job Category Professional All Job Posting Locations Bangalore Karnataka India 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 This position may be specialized into the following roles based on business needs Global Data Manager GDM Clinical Data Manager CDM Global Data Manager role-specific responsibilities Perform trial level oversight controls and or execute data management activities per applicable procedures with DML direction 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 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 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