Job Description

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Trial Manager - Early Development and Clinical Pharmacology (Oncology). This position can be located remotely within the United States.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

The Trial Manager - Early Development and Clinical Pharmacology (ED&CP) will be responsible for the local management of a trial in one or more countries and to deliver quality data and trial documents/records that are compliant with assigned clinical protocol, codes of Good Clinical Practice (GCP), Healthcare Compliance Requirements (HCC), Standard Operating Procedures (SOPs) and local regulatory requirements. This individual will act as the primary point of contact at a country level for assigned studies. Perform the Local Trial Manager (LTM) tasks including operational oversight of assigned protocol(s) from start-up to database lock and closeout activities as described in Global Clinical Operations (GCO) procedural documents. Perform the Global Trial Leader (GTL) tasks as described in GCO procedural documents for ED&CP studies which follow the ED&CP hybrid oversight model. May perform GTL and Site Manager (SM) tasks as described in GCO procedural documents for ED&CP studies. Actively contribute to process improvement initiatives, and training and mentoring of SMs and Clinical Trial Assistants (CTAs).

Principal Responsibilities:

* Collaborate with the Functional Manager (FM) for performing study feasibility and site assessments, providing recommendation of suitable sites for selection to participate in the trial according to ED&CP decision tree. Ensure appropriate follow-up of pre-trial visit activities. Collaborate with the Global Program Leader (GPL), GTL, FM and other study team members to select final sites list.
* Contribute to the development of study management documents at a country level or initiates development of these documents for trials which follow ED&CP Hybrid Oversight Model.
* Lead and coordinate local trial team activities in compliance with GCO SOPs, other procedural documents and applicable regulations. Lead local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget, including, but not limited to, development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting (if applicable).
* Ensure that all Serious Adverse Events (SAE)/Product Quality Complaints (PQC)/ Suspected Unexpected Serious Adverse Reactions (SUSAR) are reported within reporting timelines and documented as appropriate.
* Maintain and update trial management systems. Use study tools and management reports/dashboards available to analyze trial progress.
* Monitor country and overall study progress (if applicable) and initiate corrective and preventive actions when the trial deviates from plans and communicate study progress and issues to GPL, GTL and study management teams (e.g. ensure appropriate documentation and follow-up related to protocol issue escalation).
* May submit requests for vendor services and may support vendor selection. Review and approve site and local vendor invoices as required.
* May assist Contract and Grant team for negotiation of trial site contracts and budget. Collaborate with Clinical Forecasting and Analytics for forecasts and management of GCO budget to ensure accurate finance reporting and trial delivered within budget. Adhere to finance reporting deliverables and timelines.
* Accountable for set-up and conduct of Investigator Meetings (either local or multi-country) if applicable and collaborate with SM for site initiation visits.
* Conduct trial team meetings and provide or facilitate SM training when needed and build key competencies (i.e. implementation of study amendment-and changes in study related processes).
* Review and approve Visit Reports submitted by SM within procedural timelines and identify issues and/or trends across a trial/project and escalate deviation/issues to the GTL and FM as needed. Support implementation of Analytical Risk-Based Monitoring (ARBM) model as applicable.
* Support SM in setting up action plan in case data entry timelines are not respected.
* Ensure coordination of study supplies at country level or study level as applicable and ensure that clinical drug supplies are appropriately handled, administered and stored in strict adherence with investigational product preparation and administration guidelines in collaboration with SMs, Pharmacy Investigational Product Specialist (PIPS) and Site Investigational Product Specialist (SIPS).
* Monitor sites recruitment and set up action plan in collaboration with SM in case of non-enrolling sites.
* Prepare master informed consent and country specific informed consent(s) in accordance with GCO procedural document/templates. Review and manage site specific informed consent forms in accordance with GCO SOPs, other procedural documents and applicable regulations.
* Organize Independent Ethics Committee (IEC)/Health Authority (HA) approvals, if applicable and ensure that the trial is in compliance with local regulatory requirements.
* Work with SM to ensure Corrective and Preventative Actions (CAPAs) are developed and implemented for audits and inspection or any quality related visits (e.g. On-Site Quality Monitoring Visit (OSQMV)).
* Comply with relevant training requirements.
* Act as expert for assigned protocols. Develop therapeutic area and early development knowledge to support roles and responsibilities. May represent GCO on cross-functional teams.
* Act as primary local contact in GCO for a trial. Establish and maintain excellent working relationships with external stakeholders, in particular investigators, trial coordinators, other site staff, key contacts in ED&CP and other internal stakeholders.
* Actively contribute to process improvements initiatives, and training and mentoring of SMs and CTAs.
* Conduct Accompanied Site Visits with SM as delegated by FM
* May assume additional responsibilities or special initiatives such as Champion or Subject Matter Expert.
* May also be responsible for GTL and SM tasks depending on the studies assigned.

Qualifications
* A minimum of an Associate's degree or completion of a Nursing Program (LPN) is required. A Bachelor's degree in Health, Science or Nursing (RN) is preferred.
* A minimum of 2 years of clinical research/clinical trial experience is required.
* Clinical research/clinical trial experience in Early Development and Clinical Pharmacology is preferred.
* Experience in a Phase 0, Phase I or Phase Ib trial setting is preferred.
* Experience in the Oncology Therapeutic Area is required.
* Strong knowledge of the drug development process, including Good Clinical Practices (GCPs) and FDA Code of Federal Regulations, is required.
* Project management experience is required.
* Site monitoring experience is preferred.
* Strong computer skills in appropriate software applications and related clinical systems required.
* Must have excellent oral and written communication skills.
* The ability to work at a fast pace within small exploratory international study teams in a fastchanging environment is required
* The ability to work on multiple trials in parallel in different disease areas required.
* Minimal business travel (meetings, training, etc.) is required.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location
United States-New Jersey-Raritan-920 US Highway 202
Other Locations
North America-United States
Organization
Janssen Research & Development, LLC (6084)
Job Function
R&D;
Requisition ID
2105900742W