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.
Responsibilities Full 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.
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