Clinical Research Manager (Clinical R&D)
This Clinical Research Manager will be responsible for clinical trial management within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
DUTIES & RESPONSIBILITIES
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones
• 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;
• Manages and oversees 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;
• Is responsible for clinical data review to prepare data for statistical analyses and publications;
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
• 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, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), ensuring cross-functional alignment;
• 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 (deliver on time, within budget and in compliance with regulations and SOPs);
• Plans, tracks and manages assigned project budgets to ensure adherence to business plans;
• Contributes in clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc. including during sponsor regulatory inspections;
• Serves as the clinical representative on a New Product Development team;
• Is 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 and that all resources needed to do so are available and in good condition;
• Manages and mentors resources assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency;
• Is responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development;
• May perform other duties assigned as needed;
• Is responsible for communicating business related issues or opportunities to next management level. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• 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. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed.
EXPERIENCE AND EDUCATION
• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
• 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 required.
• Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• 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 & AFFILIATIONS
Functional and Technical Competencies:
• Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
• Ability to provide scientifically strategic and scientific clinical research input across New Product Development and Life-Cycle Management projects, including complex and/ or transformational projects;Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
• Strong presentation and technical writing skills;
• Strong written and oral English communication skills;
• Comprehensive understanding of clinical trial regulations across multiple regions;
• Demonstrates competencies in the following area are required:
o Ability to lead teams to deliver critical milestones, including complex projects
o Strong project management skills with ability to handle multiple projects
o Strong people management skills
o Change agent in team development and progression
Strong leadership required in alignment with J&J Leadership Imperatives:
• Connect – Develop strong collaborative relationships with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/ EDS. Create strong and productive partnership with resource providers and vendors.
• Shape – Make recommendations for and actively participate and lead in departmental process improvement activities. Through efficient use of resources, shape the way clinical trial management is conducted and resources are utilized.
• Lead – Continually develop expertise to provide strategic and scientific clinical research capability. Ensure appropriate escalation of compliance issues.
• Deliver – Ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned.
RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
• Reports to Clinical Research Associate Director or Clinical Research Director
• Functions that this position is responsible for (direct/ indirect management):
o Clinical Study Administrator
o Clinical Research Specialist
o Senior Clinical Research Specialist
o Clinical Research Leader
• Expected to build collaborative relationships with key internal partners and stakeholders. Ref. duties and responsibilities section.
LOCATION & TRAVEL REQUIREMENTS
• Primary location for this position is Diegem.
• Ability to travel approximately 20-25% depending on the phase of the program.
• Interaction with physicians and research staff at centers selected for involvement in clinical research