In Global Development Medical Affairs Operations (GD MAO) in EMEA region we are currently looking for 3:
Global Trial Leaders
Focusing on 3 different Therapeutic Areas:
Oncology & Hematology,
Infectious Diseases & Vaccines.
All these 3 positions can be based in any location in Europe, with preference of co-location at one of the headquarter offices in Belgium or G5 countries.
The position is accountable for end-to-end operational management of clinical trials assigned by the Global Program Leader or Global Operations Head within a Therapeutic Area, within agreed timelines and budget, in alignment with all the applicable SOPs and regulatory requirements. This position serves as single point of end-to-end accountability for assigned trials and leads the Study Management Team (SMT) by interfacing with the correspondent Clinical Teams, Global Operations Support CoE Teams (GOS), other Global Development (GD) functions, Global Clinical Operations (GCO) colleagues, Study Sites (if applicable), and Medical Affairs.
Considered the leader of the SMT. Main focus is on trial management supervision, planning and coordination. As part of the End to End Process (E2E) includes trial set-up, execution, analysis and reporting (includes trial closure) and post-study activities. Measures study progress against agreed upon timelines to milestones.
Ensure accurate budget management for assigned trials. This includes ensuring vendors and affiliate budgets are tracking according to plan. Ensure budget updates are made to account for scope changes.
Ensure enrollment commitments meet the projected enrollment across the regions at the clinical trial level, monitors patient recruitment at the trial level, and ensure timely and accurate documentation and communication of study progress and issue escalation to appropriate team members. Responsible to proactively build risk mitigation plans.
Ensure compliance with Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.
Ensure that the SMT operate in a constant state of inspection-readiness by maintaining complete, accurate and timely data and essential documents in appropriate systems (e.g. CTMS and VTMF) according to expectations (metrics) and archiving retention requirements. Work with Quality Management (QM) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
In coordination with the Global Program Leader and Study Responsible Physician (SRP), the GTL is responsible to ensure appropriate trial-specific training to the GCO, applicable vendors, Janssen functional groups and to the site study staff. Work with GCO staff in the set-up and coordination of Investigator Meetings, if applicable.
Ensure deliverables are carried out according to the trial plan. Provides updates to all SMT and appropriate Clinical Team members on the deliverable status. Ensure required reports are generated and available for real time tracking of trial status according to trial plan.
Strong interaction with the Medical Affairs, Operating Companies, Integrated Data Analytics & Reporting (IDAR), Quantitative Sciences (QS), Clinical Supplies, Quality Management (QM) and external vendor groups.
Bachelor’s degree or equivalent required, preferably in Life Sciences (e.g. Biology, Chemistry, Biochemistry, Nursing, Pharmacy, Physiology).
Minimum of 8 years clinical trial 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.
Requires clinical research operational knowledge, strong project planning/management expertise and effective communication skills. Should be flexible and able to manage regional teams in a virtual and highly matrixed environment. Experience in coordinating global teams in a virtual environment for a minimum of 2 years is an additional asset.
Strong working knowledge of ICH-GCP and local laws and regulations.
Consistent track record in successfully managing trials and leading country teams from start-up to database lock.
Excellent decision-making and strong financial management skills are essential to this position.
Specific therapeutic area experience may be required depending on the position.
Effective leadership skills and proven ability to foster team productivity and cohesiveness.
Computer literacy is also required.
Belgium-Antwerp-Beerse- Other Locations
France-Île-de-France-Paris, Italy-Lombardia-Milan, Germany-North Rhine Westphalia-Rhein-Kreis Neuss, Spain-Community of Madrid-Madrid, United Kingdom-England-London, Netherlands-South Holland-Leiden Organization
Janssen Pharmaceutica N.V. (7555) Job Function
R&D Requisition ID
Open Positions from Johnson & Johnson Family of Companies