Analyst II, Clinical Data Manager

Johnson & Johnson•Titusville, NJ

1d•Hybrid

About The Position

The Analyst II, Clinical Data Manager is a professional individual contributor role at the junior level that will provide oversight and accountability and/or execute 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. This individual will make recommendations and influence decisions for specific trials or assignments. Analyze and provide input into decisions with direction from manager or Data Management Leader (DML). The work is received in broad terms and is reviewed on an ongoing basis with the DML and the amount of instruction is limited.

Requirements

A minimum of a Bachelor's degree is required, preferably in Clinical Data Management, Life Sciences or Computer Sciences.
A minimum of 2 years of experience in the Pharmaceutical industry, Contract Research Organization (CRO), or related industry is required.
Experience in clinical drug development within the Pharmaceutical industry or related industry is required.
Experience working with cross-functional stakeholders and teams is required.
Must have excellent verbal and written communication skills.
Must have the ability to adapt to a rapidly changing organization and business environment.
The ability to collaborate with all levels of management across a matrix environment is required.

Nice To Haves

Advanced degree (Master’s, PharmD, PhD) preferred.
Clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols is preferred.
Knowledge of current clinical drug development processes is preferred.
Knowledge of applicable international guidelines regarding data management of clinical trials is preferred.
Knowledge of technology platforms and systems to capture and process data (e.g., Medidata Rave, Inform) is preferred.
Understanding of data privacy rules in relation to clinical data exchange is preferred.
Experience in the Oncology Therapeutic Area is preferred.
Team leadership experience is preferred.
Project management experience is preferred.

Responsibilities

Take on 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 Electronic Code of Federal Regulations (eCFR) 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) for 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 Johnson & Johnson 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 Therapeutic Area (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 (complex) scientific study data review and management of CDM, Study Responsible Scientist (SRS), and Study Responsible Physician (SRP) related queries in Electronic Data Capture (EDC) system. Involvement in other clinical data review activities (e.g., Coding, Serious Adverse Event (SAE) reconciliation) is possible.
Collaborate with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.

Benefits

medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
consolidated retirement plan (pension) and savings plan (401(k)).
long-term incentive program.
Vacation - 120 hours per calendar year
Sick time - 40 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
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours