Trial Manager II - Early Development & Clinical Pharmacology (Immunology)
Janssen Research & Development, LLC, a member ofJohnson & Johnson's Family of Companies, is recruiting for a Trial Manager II - Early Development & Clinical Pharmacology (Immunology). 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, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
The Early Development & Clinical Pharmacology (ED&CP) Trial Manager II (TM II) is 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), Standard Operating Procedures (SOPs), Health Care Compliance requirements (HCC) and local regulatory requirements.
He/she acts as the primary point of contact at a country level for assigned studies. The TM II 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 TM II performs the GCDO Trial Leader (GTL) tasks as described in GCO procedural documents for ED&CP studies which follow the ED&CP hybrid oversight model. The TM II may perform the Site Manager (SM) tasks as described in GCO procedural documents for ED&CP studies. The TM II actively contributes to process improvement initiatives, training and mentoring of TMs, SMs and Clinical Trial Assistants (CTA). Compared to a Trial Manager, a TM II is often assigned to multi-center complex protocols and can work across Phase 0 - IIa studies in multiple therapeutic areas as needed to drive business needs.
- Besides the LTM tasks, a TM II may also be responsible for GTL and SM tasks depending on the studies assigned. For the GTL and SM tasks reference is made to the Job Description for the ED&CP GTL and SM and the GCO Procedural Documents
- Collaborates with the 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 GPL (GCDO Program Leader), GTL, country TMs (if applicable), FM and other study team members to select final sites list.
- 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 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 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 analyse 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 GPL, GTL 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 & Grant (C&Gs) for negotiation of trial site contracts and budget. Is 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 TM/SM training when needed and build 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 GTL 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, PIPS (Pharmacy Investigational Product Specialist) and SIPS (Site Investigational Product Specialist).
- Monitors sites 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 development knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.
- Acts as primary local or multi country contact in GCO for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, trial coordinators, other site staff, key contacts in Early Development and/or Clinical Pharmacology and other internal stakeholders.
- Actively contributes to process improvement initiatives, and training and mentoring of SMs, CTAs and other TMs
- Conducts accompanied site visits with SM as delegated by FM.
- Assumes additional responsibilities or special initiatives such as Champion or Subject Matter Expert.
- Represents functional area in process initiatives
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
- A minimum of an Associate's degree or completion of a Nursing Program (RN) is required. A Bachelor's degree in a Health or Science discipline is preferred(or equivalent experience is required.)
- A minimum 4 or more years of clinical trial management experience (in addition of site monitoring experience) is required.
- Previous experience in Early Development/Clinical Pharmacology trials, Phase I Commercial trials is preferred.
- Early development experience is preferred.
- Experience in mentoring/coaching and providing training to TM/SM/CTAs and Strong leadership skills with ability to lead initiatives/small team is preferred.
- Clinical research experience in Immunology is preferred.
- Solid understanding of the drug development process including ICH/GCP and local regulatory requirements is required.
- Flexible mindset and ability to work at a fast pace within small exploratory international study teams in a fast-changing environment is required
- Ability to work on multiple trials in parallel in different disease areas is required.
- Strong computer skills in appropriate software and related company clinical systems is required.
- Proficient in speaking and writing the country language and English is required
- Strong written and oral communication is required.
- Willingness and flexibility to travel is required, with occasional/regular overnight may apply.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
United States-New Jersey-Raritan
North America-United States
Janssen Research & Development, LLC. (6084)
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