Location
Bangalore | India
Job description
Job Description
Johnson & Johnson is currently recruiting a Manager, Clinical Data Management to be based out of Fort Washington, PA or Skillman, NJ.
Johnson & Johnson Consumer Inc., based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S Baby, BAND-AID, NEUTROGENA, TYLENOL, MOTRIN, and LISTERINE. Each one of our consumer businesses embraces innovative science to create products that anticipate consumer needs and create experiences that help them live healthy, vibrant lives.
Responsibilities will include, but are not limited to
- Plans and manages the design and implementation of Data Management tasks for complex human use research activities in order to successfully achieve strategic objectives
- Ensures all Data Management activities are conducted in accordance with high ethical and quality standards, all applicable GCP regulations and company procedures
- Coordinate with Data Management lead in the development of SOPs and other data management standards
- Collaborates with other functions such as Clinical and Biostatistics in evaluating and/or implementing opportunities to improve Data Management solutions
- Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects
- Responsible for end to end clinical data management activities and serves as a primary point of contact for internal and external study team members with minimal oversight from senior data management resources
- Provides strong quality and project oversight over third party vendor responsible for data management deliverables
- Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data)
- Enforces data standard conventions and quality expectations for clinical data per defined processes
- Contribute to the definition of data structure standards
- Authors, reviews/revises DM related study plans including Data Management Plan, Edit Check Specifications, eCRF Completion Guidelines and other study documents to ensure quality and standardization
- Chairs Data Quality Review meetings with cross functional study team members to ensure ongoing review of clinical study data accuracy, quality and completeness
- Represents DM on cross-functional project teams & submission teams
- Provides support to Health Authority inspections and audits
- Represents Data Management on cross-functional project teams
- Evaluates proposals from external service providers
- Supervises direct DM reports for planning and managing all relevant DM activities within the assigned therapeutic areas for timely and quality deliverables and within the budget
- Mentor junior professionals for skill set advancement
- FSP/CRO/Vendor Oversight
- May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)
Qualifications
- Bachelors degree in mathematics, Science or a related field required
- At least 8 years of clinical data management experience in healthcare related industry
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
- Sound knowledge of all applicable regulations including; CFR, GCP, ICH guidelines and industry standard practices regarding data management
- Proficiency with Clinical Data Management System required
- Strong project management; Exhibits expertise in metrics analysis and reporting methodologies
- Strong oral and written communication skills
- Communicate effectively with senior management and cross-functional teams
Job tags
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