Clinical Research Manager
Il y a 3 mois
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;
- 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;
- 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, 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;
- 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.
- May perform other duties assigned as needed;
**Qualifications**:
EXPERIENCE AND EDUCATION:
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 previou
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