Job Description - Clinical Research Manager, Galway, Ireland. (2406215405W)
Clinical Research Manager, Galway, IrelandJohnson & Johnson is currently seeking a Clinical Research Manager, Galway, Ireland. 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/.
Duties & ResponsibilitiesServes as a Clinical Research Manager within the Clinical R&D Department to complete and lead company-sponsored clinical trials, ensuring compliance with timelines and study achievements.Has oversight of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.Handles and coordinates ordering, tracking, and accountability of investigational products and trial materials.Ensures applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed.Is responsible for team's interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel.May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.In EMEA, responsible for Regulatory Affairs related tasks associated with clinical trials and evidence generation.Contribute to the development and delivery of appropriate Global EGS (Evidence Generation Strategies)/ EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management.Ensures input and strong alignment from key regional Clinical R&D leads and other strategically important countries/ regions in the development of the EGS/ EDS.Leads in study design to develop appropriate clinical trials to meet the clinical evidence needs.May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.Leads in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, Abstracts, Manuscripts, Clinical Evaluation Reports, etc.Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments.Plans, tracks and leads assigned project budgets to ensure adherence to business plans.Contributes in clinical scientific discussions with regulatory agencies/advised bodies to drive support of the clinical and regulatory strategy.Serves as the clinical representative on a New Product Development team.May be responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports.Conducts review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.Is responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices.Leads and mentors resources assigned to designated clinical trials to provide quality deliverables while maintaining efficiency.Is responsible for providing performance feedback to direct reports (if applicable) as well as mentor and assistance in their development.Is responsible for communicating business-related issues or opportunities to the next management level.Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.Should develop a strong understanding of the pipeline, product portfolio and business needs.Manages work independently and independently solves problems arising during clinical trial execution.May perform other duties assigned as needed.QualificationsEducationMinimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.ExperienceA 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 required.Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, 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.Required Knowledge, Skills, Abilities, Certifications/Licenses and AffiliationsDetailed understanding of clinical research science and processes along with a broad and extensive understanding of product development processes.Ability to provide scientifically strategic and scientific clinical research input across New Product Development and Life-Cycle Management projects.Strong presentation and technical writing skills.Strong written and oral English communication skills.Comprehensive understanding of clinical trial regulations across multiple regions.Ability to lead teams to deliver critical milestones.Strong project management skills with ability to prioritise multiple projects.Strong people leadership skills.Change agent in team development and progression.Primary LocationEurope/Middle East/Africa-Ireland-Galway-Galway
OrganizationJob FunctionClinical Development & Research & Non-MD
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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