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Janssen Pharmaceuticals Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Summer Intern position within the Portfolio Delivery Operations Department within Global Development.  At this time the position will be considered remote, however, that may change depending on the COVID-19 Pandemic restrictions.  If so, the position will be working out of the Spring House, Pennsylvania office.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat, and cure disease inspire us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

The Portfolio Delivery Operations Team is focused on conducting clinical trials in various therapeutic areas of focus.  The Internship Program will provide undergraduate students with practical experience in the end-to-end delivery of global clinical trials, working with cross-functional teams, learning the global regulations, and exposure to all aspects and functions within the conduct of clinical trials.

POSITION COMPONENTS

In this role, you will:

• Support operational aspects of PDO clinical trials, both internally managed, outsourced trials, and the Biomarker team as needed, with variation across all phases of a trial (planning, start-up, execution, data analysis, reporting, and closure).
• Supporting the trial team, including the Global Program Leader (GPL), Trial Leader (GTL), Clinical Trial Manager (CTM), Site Manager (SM), or global Clinical Trial Associate (gCTA) as required.

Responsibilities may include:

• Tracking trial progress towards planned milestones, as well as related progress analysis and follow-up, tracking trial and country budgets and support invoice reconciliation, support protocol and country feasibility, site selection, and vendor set-up, performing trial-specific system set-up/access management, system data entry.
• Responsible for internal and external meeting planning, coordination, outcome documentation, and related follow-up, responsible for document management, and Biomarker Team tasks, as requested.

DELIVERABLES:

Adherence to applicable SOPs, Work Instructions, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc. is mandatory. Compliance with relevant training requirements is required.

Assignments may include the following:

• Assist in trial-specific document management, including finalization, distribution, and document revision management and archiving, with a strong focus on inspection readiness.
• Assist in ancillary supply management, including ordering, distribution, and tracking.
• Ensure the current trial status and tracking of trial-related information is always available in the clinical trial management system(s) (CTMS) and or tracking tools.
• Ensure trial-specific data are up-to-date, complete, and accurate during all phases of the trial in collaboration with CRO, Local Trial Managers, and Site Managers.
• Ensure trial delivery according to the agreed-upon timelines/milestones by conducting supportive trial coordination activities and tracking of trial timelines and deliverables.
• Responsible for review/management of Trial Master File (TMF) for completeness and timely provision of TMF content across all functions.
• Run dashboards & metrics reports.
• Coordinate and participate in internal and external trial-specific meetings, as necessary, and document outcomes, actions, and decisions. A follow-up to resolution when required.
• Support medication-related activities such as shipment tracking for non IWRS trials, coordination of relabeling, recall, product quality compliant, TMEQ, and TOR management, and follow-up
• Maintain key trial-specific information, including a trial contact list.
• Set-up of trial-specific training curriculum and follow up on timely training completion
• Conduct activities that support quality oversight and inspection readiness.
• Work with internal partners to assist in the management of activities such as country and site feasibility and obtaining country-specific clinical trial insurance.
• Work with internal partners, and external vendors including Contract Research
• Organization/Academic Research Organization for outsourced trials/activities.
• Assist with applicable system support, including tracking of vendor work orders and change orders, tracking, and analyzing the trial budget, including actual vs. plan trial budget spend, follow-up on variances, as needed.
• Provide an overview of data management metrics as needed, including the status of data entry/missing pages, source data verification progress, and query resolution.
• Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
• Conduct activities to support timely and successful database locks.
• Conduct activities to support trial planning, conduct, and close-out, as delegated by the SM, CTM, GTL, and/or GPL.
• May contribute to process improvement and/or non-project work.  If applicable, region-specific deliverables will be specified.

ADVANCED:

• Autonomy in the execution of global clinical trial assistance services (e.g. provide status analysis of metric reports).
• Depth of knowledge with global clinical trial assistance services.
• Provide coaching/mentoring to less experienced CTAs/interns, if applicable.
• Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document. Interfaces – Primary/Other:
• Primary interfaces: Provider Functional Manager, Point of Contact, Site Manager, Clinical Trial Team, Global Program Lead, Global Trial Lead, Clinical Trial Manager, Local Trial Manager, Study Responsible Physician, Global Data Manager, Trial Supply Manager, Regulatory Liaison, and Recruitment Specialist for assigned trials.
• Other Interfaces: Quality and Compliance Manager/Specialist, Training Manager.
• External Interfaces:
• Clinical Research Organizations, various vendors such as Central Laboratory, IWRS, ePRO, translator.

QUALIFICATIONS

• Must be currently in a Bachelor's degree program with a science/medicine/biomedical major.
• Excellent organization and project planning skills.
• Clear and concise written and verbal communication skills.
• Experience in developing presentations and presenting key information to stakeholders.
• Ability to perform activities in a timely and accurate manner.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

PRIMARY LOCATION

United States-Pennsylvania-Spring House-Welsh & McKean Roads

ORGANIZATION

Janssen Research & Development, LLC (6084)

JOB FUNCTION

General Administration

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