At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Clinical Development & Research – Non-MD
Job Category:
People Leader
All Job Posting Locations:
Diegem, Flemish Brabant, Belgium
Job Description:
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for an Associate Director Clinical Operations to be based in Diegem, Belgium.
Purpose:
The Associate Director Clinical Operations will be responsible for the operational management within the EMEA Clinical Research Department of J&J MedTech Electrophysiology by leading a team of clinical research professionals to ensure clinical processes are conducted compliant, optimized, consistent and efficient within the Clinical Department while fostering strong, productive relationships with colleagues across the organization.
TASKS AND RESPONSIBILITIES :
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Is responsible for the operational structure, processes and activities within the clinical research department.
• Is responsible for clinical process optimalization and coordination in collaboration/partnership with clinical affairs and cross-functional teams to ensure consistency and efficiency among processes and execution (ex. contracting, training, safety, submission, audit, ...)
• Maintains knowledge and oversight of existing clinical processes and identifies areas for improvement. Initiates improvement initiatives, with collaborative relationships of applicable cross-functional partners and ensures implementation across applicable clinical studies.
• Ensures clinical processes are conducted consistently; identifies variances and implements corrective actions if needed. Performs training of the clinical research team on (updated) clinical processes.
• Implements continuous improvement and innovation by adopting new tools, techniques and best in class industry practices.
• Serves as a subject matter expert in clinical processes and project management of clinical study development and execution.
• Fosters strong relationships with external stakeholders to shape and influence relevant procedures and policies.
• Performs a continuous impact assessment and implementation of EU MDR or other applicable directives or guidelines related to clinical studies and related processes (i.e., Eudamed Clinical Module, safety reporting, study reporting requirements, etc.) and ensures appropriate implementation in clinical research processes and clinical study deliverables
• Ensures submission deliverables, processes and study documentation are up to date with latest SOPs, regulatory processes/guidelines, EC/CA findings, etc.
• Maintains an up-to-date overview of all clinical studies with high-level milestones, and ensures crossfunctional teams (data science, quality team, contracting, finance) are timely informed of significant updates.
• Responsible for a consistent and timely creation of study budget actuals and forecasts for all clinical studies, in collaboration with cross-functional teams (data science, contracting) and finance, ensuring adherence to business plans.
• Responsible for management and mentoring of the Clinical Research Process Manager / clinical finance coordinator.
• Manages and mentors the clinical study administration and other clinical resources (if applicable) assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency.
• Responsible for providing performance feedback for direct reports as well as coaching and assistance in their development.
• Builds and maintains strong relationships with internal and external stakeholders, including clinical team members, data science team, contracting group, business compliance and finance team.
• Manages work independently. Independently solves problems arising during job execution and will seek guidance for more complex problems as needed.
• Functions as a reliable, trusted resource of accurate, up-to-date process knowledge as requested by key stakeholders.
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.
EDUCATION :
• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
EXPERIENCE :
• A minimum of 8 years related scientific/ technical experience, including leadership/ management role within Clinical Research.
• Significant previous experience in clinical project leadership across multiple studies/ programs is required.
• Experience working well with cross-functional teams is required.
• Experience with budget planning, tracking and control is preferred.
• Relevant industry certifications are preferred (i.e., GCP, ISO 14155, MDR,…).
• Clinical/medical background is a plus.
• A minimum of 1-2 year people management related experience is a plus.
• Medical device experience is highly preferred.
SIKLLS :
• Proven track record in delivering clinical programs within clinical/ surgical research setting, on time, within budget and in compliance with SOPs and regulations.
• Strong presentation skills.
• Strong written and oral English communication skills.
• Strong leadership and team management skills
• Planning and organization
• Problem-Solving
• Comprehensive understanding of clinical trial regulations across multiple regions.
• Demonstrates competencies in the following area:
o Ability to lead teams to deliver critical milestones, including complex projects
o Strong project management skills
o Strong people management skills
o Effective management of project budget processes (preferred)
o Ability to influence, shape and lead without direct reporting authority
o Change agent in team development and progression
Required Skills:
Clinical Operations, Medical Devices
Preferred Skills:
Communication, Leadership
