The position is accountable for the operational oversight of assigned Investigator Initiated Studies (IISs) and responsible for local management of IISs in one or more countries from start-up through close-out activities assuring that IIS study progress, safety reporting, drug and financial management adheres to the contract and all applicable Policies, SOPs, Work Instructions and regulatory requirements.
This position interfaces externally with IIS Sponsor-Investigators, and internally with the IIS Trial Manager Lead,Global Clinical Development Operations (GCDO) 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 Manager (GTM) tasks as described in Global Clinical Development Operations (GCDO) procedural documents for IISs for which no GTM has been assigned.
PRINCIPAL RESPONSIBILITIES: List major responsibilities and duties of the position. List most complex or difficult parts of job first. Describe scope of responsibilities.
Accountable for the operational oversight of assigned IISs at an operating company level from start-up (post ReCAP approval) through receipt of the final deliverable and close-out activities and that IISs are conducted in accordance with all applicable regulations/guidelines and applicable Janssen Policies, SOPs and WI’s
Acts as the central contact for designated project communications, correspondence and associated documentation for assigned IISs.
Maintains communication with the 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 and initiates corrective and preventative actions when the trial deviates from plans, communicates study progress and issues to IIS team members in support of Medical Affairs/R&D Study Responsible Physician/Study Responsible Scientist.
Ensures that contracts, budgets and payment schedules are prepared in accordance 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/NSAEs, PQCs) are reported and processed according to all applicable SOPs/WIs.
Accountable for budget oversight for assigned IISs including forecasting. Communicates budget discrepancies or payment delays with rationale to Operating Company representatives and the IIS Trial Manager Lead
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 IIS Trial Manager Lead and Study Responsible Physician/Study 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 working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff, internal stakeholders, including Medical Affairs and R&D Therapeutic Areas.
Complies with relevant training requirements.
Contributes to process improvement initiatives and training and mentoring or other IIS team members.
Participates in preparing for or conducting Health Authority inspections and internal audits.
EDUCATION AND EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.
4-year University/Bachelor’s degree or equivalent is required. A degree in health sciences, Nursing or related scientific field is preferred.
Related Experiences :
Minimum of 5 years clinical research operations experience in the pharmaceutical industry or CRO; however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility
Experience in managing investigator initiated studies and study types (interventional, non-interventional and/or registries) is preferred.
Specific therapeutic area experience may be required depending on the position. Should have a solid understanding of the drug development process including ICH/GCP and local regulatory requirements.
Solid leadership skills are required. Flexible mindset and ability to work in a fast-pace environment
Ability to work on multiple IISs in parallel in different therapeutic areas is required.
Proficient in speaking and writing the country language and English language. Good written and oral skills.
Requires clinical research operational knowledge, project planning/management and communication 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 productivity and cohesiveness of the team.
Good analytical skills and solution oriented, actively seeking input from others.
Willingness to travel occasionally with overnight stays depending on region.
Primary Location Netherlands-North Brabant-Tilburg Other Locations Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Netherlands-South Holland-Leiden Organization Janssen-Cilag Netherlands (8345) Job Function Clinical Trial Administration Requisition ID 1805627830W