Senior Data Manager

Johnson & Johnson•Raritan, NJ

28d•Hybrid

About The Position

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 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 The Senior Data Manager is a professional individual contributor role at experienced level that provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity trials. The Senior Data Manager makes recommendations and decisions that have an impact on processes, timing, and structure for trials and assignments with minimal direction from manager or Data Management Leader (DML). This position also makes recommendations for processes, timing, structure, and resources at a program level. Work is received in broad terms, reviewed during major deliverables, and the amount of instruction is limited. Work is reviewed with the Data Management Leaders, or the immediate manager as needed. We are searching for the best talent for a Senior Data Manager, to be located in Titusville, NJ or Raritan, NJ. This is a hybrid position and requires you to be onsite 3 days a week.

Requirements

Bachelor's degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Clinical Data Management, Health, or Computer Sciences.
Approximately 4 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.

Nice To Haves

Advanced degrees preferred (e.g., Master, PhD).

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.