Johnson & Johnson
Clinical Research Leader
Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.
We are currently recruiting a Clinical Research Leader to join our contingent workforce. You will be working in the Biosense Webster Team of J&J Medical in Diegem, Belgium. This will be an initial contract opportunity, starting June 2022 until December 31, 2022 with high possibility of extension.
This is a 50/50 on site (Diegem) and off site (home working) position.
- This Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
- Under minimal supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines.
- Execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones
- Oversees/executes 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
- May serve as the primary contact for clinical trial sites (e.g. site management)
- Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports)
- Ensures applicable trial registration (e.g. on www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed
- Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials
- Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel
- Interfaces, collaborates and oversees Clinical Research Associates (CRAs)
- Oversees and supports the development and execution of Investigator agreements and trial payments
- 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
- May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), 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), contributing to cross-functional alignment
- May provide on-site procedural protocol compliance and data collection support to the clinical trial sites
- 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)
- Supports planning, track and manage assigned project budgets to ensure adherence to business plans
- Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy
- May serve as the clinical representative on a New Product Development team
- May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals
- Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
- May act as Clinical Safety Coordinator
- BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.
- Previous experience in clinical research or equivalent is required.
- Experience working well with cross-functional teams is required.
- Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
- Clinical/medical background is a plus.
- Medical device experience is highly preferred.
- Good understanding of clinical research science and processes along with an 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 (NPD) and Life-Cycle Management (LCM) 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 written and oral English communication skills
- Advanced project management skills with ability to handle multiple projects
- Ability to lead small study teams to deliver critical milestones, as may be assigned.
If you meet our requirements and are interested in hearing more about our Clinical Research Leader role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!