Johnson & Johnson Careers
Sr. Manager, Data Management
Clinical Data Management
Requisition ID: 1805640431W
This is a senior management level role with professional DM and DM CRO experience and knowledge. This role is responsible for multiple low to high complexity trials and/or for one or more indications /compounds of low to
medium complexity. This position serves as the single point of contact of China DM in the clinical team for the R&D Company, taking responsibility for data management quality, on time, and within budget.
This position makes decisions with direction from China DM Head and/or from Data Management Therapeutic Area Head with regards to data quality, timelines, budget, processes and structure for trials in line with business needs and in support of Medical Affaires clinical studies. Provides input for R&D
Company business planning exercises.
As a role in project management, requires detailed and accurate project planning with regards to timelines and resources. Makes decisions and predicts accurately resource allocation within the project(s) and gives input around the choice of external service providers for data management activities to China DM Head and/or IDS Therapeutic Area Head. Ensures real-time inspection readiness for all China DM deliverables for clinical trials and relevant compounds. Works on regulatory agency inspections and J&J internal audits as necessary. Responsible and accountable for DM CRO budget, project timelines and quality of deliverables for clinical trials /projects / tasks assigned within the team. Oversees E2E processes and quality of deliverables from initiation to close out as well as project timeline, and budget for China MAF trials. Leads / performs local DM vendor assessment and oversight DM vendor performance in course of business events.
Performs a role in people management, provides guidelines and conducts daily supervision on employee’s performance. Delivers input and leads timely review for direct reports within the team. Manages recruitment for new hires as well as propose / instruct career development for direct reports. Mentors and coaches on trial level responsibilities and delegates tasks assignments to data managers in consensus with China DM head. In additional of manage 0 to 6 direct reports, may supervise another 0 to 12 extra indirect reports.
Practices as Subject matter expertise, become a master of relevant skills in assigned skills/systems/project. Identifies technique gaps and proactively seek solutions. Organizes and delivers trainings as well as verify training outcomes by collecting feedbacks and observations in daily practices. Hosts Q&A sections to follow up implementations of DM quality control improvements. Participates in process, system and tool improvement initiatives within China DM. Presents/trains at investigator and monitor meetings if assigned.
A. Education /Training background:
Bachelor/Master or above degree (preferred) in a scientific discipline or health related field.
In-depth knowledge of relevant regulatory guidelines, GCP and international guidelines regarding data management. Expert knowledge of the clinical drug development process in the pharmaceutical industry and expert knowledge of the protocol. Experience with and expert understanding of DM systems e.g. Medidata Rave, iMedidata, ClinTrial, InForm. Expert knowledge of current industry standards (CDISC, SDTM, CDASH...) , of technology platforms for data exchange. Expert understanding of the therapeutic area where project/trial responsibilities are.
In-depth knowledge of project management tools and processes are required.
Excellent communication skills and (in)direct line management experience and/or knowledge.
C. Job experience:
Requires >2 years of experience as a manager of data management and >8 years of experience in data management and in clinical drug development in the pharmaceutical industry. Experience working with customers, with team leadership and with outsourcing and contract oversight.
Strong sense of prioritization and of making timely adjustments. Diligent and serious, precise thinking, strong sense of responsibility and accountability. Results and performance driven, sense of urgency. Team spirit, strong work ethic, and good self-awareness. Analyzes, provides recommendations and makes decisions with direction from manager. Strong leadership capabilities
to work with CRO, colleagues direct reports and other stakeholders. Independently working with minimal instruction required.
Excellent written and verbal communication skills in Chinese and English. Confident in giving presentations and actively participating in meetings / conferences in both languages. Sharing best practices in soft skills and communication.
J&J (China) Investments Ltd (7046)
Clinical Data Management