Senior Global Data Manager - Mumbai/Bangalore/Hyderabad

Johnson & Johnson

Dec 23

Applications are closed

Job
Full-time
Expert Level
Data
Research & Development
Mumbai

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. 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.

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.
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.
Ensure trial level oversight controls and/or data management activities are performed per applicable procedures.

FAQs

What is the job title for this position?

The job title is Senior Global Data Manager, although it may vary based on region or country requirements.

What are the main responsibilities of the Senior Global Data Manager?

The main responsibilities include overseeing data management activities, performing scientific data reviews, leading collaboration with external suppliers and internal partners, ensuring compliance with regulatory guidelines, and participating in process improvement initiatives.

What type of experience is required for this position?

Required experience includes approximately 10 years in the Pharmaceutical, CRO, or Biotech industry, with a strong background in clinical drug development and data management.

What educational qualifications are necessary for this role?

A Bachelor's degree in Clinical Data Management, Health, Computer Sciences, or a related field is required, with advanced degrees preferred.

What key skills are important for the Senior Global Data Manager role?

Key skills include strong written and verbal communication, team leadership experience, in-depth knowledge of clinical data management processes, and familiarity with international guidelines on clinical trials.

What tools or systems knowledge is necessary for this position?

Knowledge of technology platforms for data capture and processing, data privacy rules, and current industry standards like CDISC, SDTM, and CDASH is necessary.

Who does the Senior Global Data Manager report to?

The Senior Global Data Manager reports into a people manager position within the functional area, such as a Data Management Leader.

Are there opportunities for process improvement in this role?

Yes, the Senior Global Data Manager will identify and participate in process, system, and tool improvement initiatives.

What are the principal relationships for this position?

Principal relationships include contacts within IDAR, J&J Innovative Medicine, external partners, CRO management, and industry peers.

Is team collaboration important in this role?

Yes, strong collaboration with cross-functional teams and stakeholders is crucial for success in this role.

Johnson & Johnson

Hospitals and Health Care

Science & Healthcare

Industry

10,001+

Employees

Mission & Purpose

Profound Change Requires Boldness. Johnson & Johnson is the largest and most diversified healthcare products company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world.