Sr. Trial Manager, Early Development, Oncology

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Remote (US), 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

About Oncology

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.

Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results.

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 Sr. Trial Manager, Early Development, Oncology to be remote in the United States.

Purpose: The Sr Trial Manager Early Development is responsible for the local management of a trial in one or more countries acting as the primary point of contact at a country level for assigned studies and for delivering 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. The Sr. Trial Manager Early Development performs 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 GCO procedural documents. The Sr. Trial Manager Early Development may perform the Trial Delivery Leader (TDL) tasks as described in GCO procedural documents for Early Development and Clinical Pharmacology (ED&CP) studies which follow the ED&CP hybrid oversight model. The Sr. Trial Manager Early Development may perform the Site Manager (SM) tasks as described in GCO procedural documents for ED&CP studies. The Sr. Trial Manager Early Development actively contributes to process improvement initiatives, and training and mentoring of SMs and Clinical Trial Assistants (CTA).

You will be responsible for:

• •Besides the LTM tasks, a Sr. Trial Manager Early Development may also be responsible for TDM and and SM tasks depending on the studies assigned. For the TDM and SM tasks reference is made to the Job Description for the ED&CP TDL and SM and the GCO Procedural Documents.
• •Collaborates 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. Ensures appropriate follow-up of pre-trial visit activities. Collaborates with the Program Delivery Leader (PDL), TDL, FM, Site Strategy Lead (SSL), and other study team members to create the final list of sites.
• •Contributes 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.
• •Leads and coordinates local trial team(s) activities in compliance with GCO SOPs, other procedural documents and applicable regulations. Leads 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).
• •Ensures 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.
• •Maintains and updates trial management systems. Uses study tools and management reports/dashboards available to analyze trial progress.
• •Monitors country and overall study progress (if applicable) and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to PDL, TDL and study management teams (e.g., ensures appropriate documentation and follow-up related to protocol issue escalation).
• •May submit requests for vendor services and may support vendor selection. Reviews and approves site and local vendor invoices as required.
• •May assist Contract and Compliance Services (CCS) team for negotiation of trial site contracts and budget.
• •Responsible or collaborates with Clinical Forecasting & Analytics for forecasts and management of GCO budget to ensure accurate finance reporting and trial delivered within budget. Adheres to finance reporting deliverables and timelines.
• •Accountable for set-up and conduct of Investigator Meetings (either local or multi-country) if applicable and collaborates with SM for site initiation visits.
• •Conducts trial team meetings and provides or facilitates SM training when needed and builds key competencies (i.e., implementation of study amendment-and changes in study related processes).
• •Reviews and approves Visit Reports submitted by SM within procedural timelines; identifies issues and/or trends across a trial/project and escalates deviation/issues to the TDL and FM as needed. Supports implementation of ARBM (Analytical risk-based monitoring) model as applicable.
• •Supports SM in setting up action plan in case data entry timelines are not respected.
• •Ensures coordination of study supplies at country level or study level as applicable and ensures that clinical drug supplies are appropriately handled, administered and stored in strict adherence with investigational product preparation and administration guidelines in collaboration with SMs, Manager Pharmacy Investigational Product Specialist (PIPS), Manager Site Investigational Product Specialist (SIPS).
• •Monitors site recruitment and sets up an action plan in collaboration with SM in case of non-enrolling sites.
• •Prepares master informed consent and country specific informed consent(s) in accordance with GCO procedural document/templates. Reviews and manages site specific informed consent forms in accordance with GCO SOPs, other procedural documents and applicable regulations.
• •Organizes IEC/HA approvals, if applicable and ensures that the trial is in compliance with local regulatory requirements.
• •Works with SMs to ensure CAPAs are developed and implemented for audits and inspection or any quality related visits (e.g., On Site Quality Monitoring Visit (OSQMV))
• •Complies with relevant training requirements.
• •Acts as expert for assigned protocols. Develops therapeutic area and early