Janssen-Cilag S.A. is recruiting for an IIS (Investigator Initiated Studies) and Collaborative Studies Trial Manager for their Global Development functions (GD) on the Medical Affairs Operations (MAO) unit, located in Madrid, Spain. The position is accountable for the operational oversight of assigned Investigator Initiated Studies (IISs)/ Collaborative Studies and responsible for local management of these studies in one or more countries from the beginning through close-out activities assuring that study progress, safety reporting, drug and financial management adheres to the contract and all applicable Policies, Standard Operating Procedures (SOPs), job aids and regulatory requirements.
This position collaborates externally with IIS Sponsor-Investigators or Study Partners, and internally with the Clinical Program Leader, Functional Manager, Global Development (GD) functions, Local Operating Company Medical Affairs personnel, Healthcare Compliance (HCC/HCBI), J&J Legal, pharmacovigilance and other areas, as appropriate. The Trial Manager (TM) may perform Global Trial Lead (GTL) tasks as described in Global Development procedural documents for IISs for which no GTL has been assigned.
ResponsibilitiesFull life-cycle responsibility for assigned IISs in accordance with all applicable regulations/guidelines and relevant Janssen Policies, SOPs and WI's.Acts as the central contact for designated project communications, correspondence and associated documentation for the assigned IISs/ Collaborative Studies.Maintains communication with Sponsor-Investigator and staff during all phases of the IIS regarding study progress, issue identification/resolution, contractual matters including payments and collection of required documents.Monitors study progress, initiates corrective and preventative actions when the trial deviates from plans, communicates study progress and issues in support of Medical Affairs/R&D Study Responsible Physician/Scientist (SRP/SRS).Ensures that contracts, budgets and payment schedules are prepared alongside with IIS contract requirements and HCC/HCBI considerations.As required, in consultation with appropriate representatives of the operating company, ensures required contract amendments are prepared.Ensures that required safety information (e.g. SAEs/AEs, PQCs) are reported and processed according to all applicable SOPs/WIs.Accountable for budget oversight and forecasting for assigned projects.Communicates budget discrepancies or payment delays with rationale to Operating Company representatives and the IIS TML.Accountable for drug management (e.g. projections, requests) for assigned IISs.For IISs not progressing to agreed contract timelines and/or budget ensures an action plan is implemented and regular status updates are provided to the Clinical Program Leader, Functional Manager, and Study Responsible Physician/Responsible Scientist.Maintains documentation of assigned IIS in TMF and performs periodic review to ensure accuracy and completeness.Maintain and updates applicable Janssen systems including, but not limited to, CTMS, TMS, SharePoint, etc. Uses study tools and management reports available to analyze study progress.Develops strong therapeutic knowledge to support roles and responsibilities.Establishes and maintains excellent working relationships with external partners, in particular investigators, study trial coordinators and other site staff, internal partners, including Medical Affairs and R&D Therapeutic Areas.Contributes to process improvement initiatives and training and mentoring or other IIS team members.QualificationsRequirementsAcademic requirements: 4-year University/Bachelor's degree or equivalent is required. A degree in health sciences, Nursing or related scientific field is preferred.Shown understanding of the drug development process including ICH/GCP and local regulatory requirements.Confirmed leadership skills are required.Flexible attitude and ability to work in a fast-paced environment.Capable of working on multiple IISs in parallel in different therapeutic areas is required.Requires clinical research operational knowledge, project planning/management and high oral skills.Should have experience with and be able to participate on global, regional, or local teams in a virtual environment.Ability to actively participate and contribute to the efficiency and cohesiveness of the team.Good analytical and problem-solving skills, actively seeking input from others.For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world.
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