Job Function: Data Analytics & Computational Sciences
Job Sub Function: Clinical Data Management
Job Category:Professional
All Job Posting Locations:Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:We are searching for the best talent for our Manager, Clinical Data Management position to be located in Spring House, PA; Horsham, PA; Raritan, NJ; or Titusville, NJ.Remote work options may be considered on a case-by-case basis and if approved by the Company.
Purpose: The Manager, Clinical Data Management works under minimal supervision and may lead portions of a program, project and/or process and provide training and guidance to staff. In this role, the Manager, Clinical Data Management provides direct subject matter expertise to establish operational plans and implement products, processes and standards that have some impact on business results. This position applies in depth knowledge and experience to address complex problems that require an understanding of one or multiple related disciplines.
This position reports to Data Acquisition Functional Leadership and represents Data Management in cross functional discussions, with the ability to influence key stakeholders and contribute to strategic discussions and decisions.
This position may also participate in continuous improvement initiatives and industry work groups. This position develops strong and productive working relationships with key stakeholders within IDAR and Global Development, in addition to broader partners, external suppliers and/or industry groups.
You will be responsible for:- Planning, executi, and completion of all data acquisition activities and deliverables within assigned scope ensuring quality, compliance standards, consistency, and efficiency.
- Ensuring timely and effective maintenance of functional planning systems.
- Independently and effectively managing issue escalations, adopting appropriate escalation pathways.
- Anticipation, early detection, prevention and management of risks and issues impacting deliverables and activities.
- Leading or contributing to the development and maintenance of departmental policies, procedures, training, and standards.
- Contributing to the development of functional vendor contracts and oversee of delivery in line with agreed milestones and scope of work, R&D business planning and budget estimates.
- Contributing to the enhancement of functional, technical and/or scientific capabilities within data management.
- Influencing the external industry and/or regulatory environment through active engagement in industry forums and working groups.
- Supporting data acquisition related aspects of regulatory agency inspections and internal audits. Ensure real time inspection readiness for all data acquisition deliverables.
Qualifications / Requirements:- Bachelor's degree (e.g., BS, BA) is required, preferably in Clinical Data Management, Health, or Computer Sciences. Advanced degrees preferred (e.g., Master, PhD).
- A minimum of 6 years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry is required.
- In-depth knowledge of data management practices (including tools and processes) is required.
- In-depth knowledge of regulatory guidelines (e.g., ICH-GCP) and standards (e.g., HL7 FHIR) is required.
- Advanced project and risk management skills with an established track record delivering successful outcomes is required.
- Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors is required.
- Excellent communication, leadership, influencing and decision-making skills is required.
- Excellent written and verbal communications skills is required.
- Innovative thinking to allow for optimal design and execution of clinical development strategies is preferred.
- Development and implementation of a business change/innovative way of working is preferred.
- Experience working with data from EHR/EMR, Digital Health technologies, Real-World Data, or similar, eDC systems, eDC integration tools, and general data capture platforms is preferred.
Required Skills:Preferred Skills:Advanced Analytics, Clinical Data Management, Clinical Trials Operations, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Innovation, Leverages Information, Process Improvements, Regulatory Affairs Management, Research Ethics, Technical Credibility
The anticipated base pay range for this position is :$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
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)).
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
