Analyst II, Global Data Manager

Johnson & Johnson Innovative Medicine•Ambler, PA

2d•$92,000 - $148,350

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 Job Function: Data Analytics & Computational Sciences Job Sub Function: Clinical Data Management Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: 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 Analyst II, Global Data Manager to be located in Spring House, NJ or Raritan or Titusville, NJ. Purpose: The Analyst II Data Manager is a professional individual contributor role at junior level that provides oversight and accountability and/or executes data management activities and/or performs 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. You will be responsible for:

Requirements

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

Nice To Haves

Advanced degrees preferred (e.g., Master, PhD).
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.
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.
Approx. <10% travel (domestic or international) may be required.

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.
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.
Perform trial level oversight controls and/or execute data management activities per applicable procedures, with DML direction.

Benefits

Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits