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

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for an Analyst II Global Data Manager at junior individual contributor to provide data management activities and/or perform scientific data review for more than one trial of low to moderate complexity or for one high complexity trial. The Analyst II Data Manager makes recommendations and influences decisions for specific trials or assignments. This position analyzes and provides input into decisions with direction from manager or Data Management Leader (DML). Work is received in broad terms. Work is reviewed on an ongoing basis with Data Management Leader and the amount of instruction is limited.

This position may be located within commutable distance of High Wycombe, United Kingdom; or Mumbai, India.

Are you ready to join our team? Then please read further!

You will be responsible for:

• 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 review content and integration requirements for eCRF and other data collection tools while establishing quality expectations and dataset standards, and set timelines to monitor the 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.

Qualifications / 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. 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 and 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.
• Approx. <10% travel (domestic or international) may be required. 0% travel (domestic or international) may be required

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United Kingdom - Requisition Number: R-008882

India - Requisition Number: R-009687

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Benefits:

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority, we have a flexible working environment as we value work-life balance. We offer career development opportunities for those who want to grow and be part of our organization.