J&J Family of Companies GLOBAL TRIAL MANAGER, INVESTIGATOR INITIATED STUDIES, EMEA (GIFTs) in Leiden, Netherlands

The Pharmaceutical sector of Johnson & Johnson is now looking for a Global Trial Manager:

At Janssen, part of Johnson & Johnson, Family of Companies, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.com for more information

GLOBAL TRIAL MANAGER, INVESTIGATOR INITIATED STUDIES, EMEA(GIFTs)

Location: Netherlands, Belgium, UK, France, Spain, Germany or Italy

Full time permanent contract

Role Overview

The Global Trial Manager is accountable for the operational oversight of assigned Investigator Initiated Studies (IISs) in the EMEA (Europe, Middle East and Africa) region following IIS processes 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 Clinical Program Leader, Global Clinical Development Operations (GCDO) functions, Local Operating Company and/or Regional Medical Affairs personnel, Healthcare Compliance (HCC/HCBI), J&J Legal, pharmacovigilance and other areas as appropriate and other areas as appropriate.

There is a preference for the GTM to be stationed in one of the following locations: Netherlands, Belgium, UK, France, Spain, Germany or Italy.

Key Responsibilities:

  • Accountable for the operational oversight of assigned IISs at an operating company level from start-up 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.

  • May provide operational input to protocol development, preparation of GCDO IIS proposal documents and the Request for Service (RFS) process.

  • 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 and ensuring if applicable vendors and affiliate budgets are delivered according to plan.

  • Communicates budget discrepancies or payment delays with rationale to Operating Company Representatives and Clinical Program Leader.

  • Accountable for drug management (e.g. projections, requests) for assigned IISs. May assist in bulk drug forecasts/ordering for IIS programs

  • 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 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 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.

Qualifications

  • 4-year University/Bachelor’s degree or equivalent is required. A degree in health sciences, Nursing or related scientific field is preferred

  • Minimum of 6 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 and/or manage global, regional, or local teams in a virtual environment.

  • Excellent decision‐making and strong financial management skills are essential to this position.

  • Effective leadership skills and proven ability to foster team productivity and cohesiveness.

  • 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.

We Offer:

  • A challenging and a very interesting job in one of the biggest global pharmaceutical companies

  • An opportunity to make an impact with your actions

  • An opportunity to help others develop further and improve in their daily tasks

  • Possibilities for own further development and growth

  • Many opportunities to participate on different projects and drive Janssen’s growth further

  • Motivating remuneration and many employee benefits

Primary Location

Netherlands-South Holland-Leiden

Other Locations

Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-France, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-Spain, Europe/Middle East/Africa-Italy

Organization

Janssen Biologics (7266)

Job Function

Clinical Trial Coordination

Requisition ID

1700180581W