Clinical Research Leader

Responsibilities

• Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones
• Oversight/execution 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
• Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal supervision
• Ensure applicable trial registration from study initiation through posting of results and support publications as needed; (e.g. on www.clinicaltrials.gov)
• Management/oversight of ordering, tracking, and accountability of investigational products and trial materials
• Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel
• Oversee the development and execution of Investigator agreements and trial payments
• Ensure clinical data review to prepare data for statistical analyses and publications
• If applicable, 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 evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects
• If applicable, as part of a clinical trial, may provide on-site procedural protocol compliance and data collection support to the center
• Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated
• Deliver 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)
• Communicate business related issues or opportunities to next management level
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
• Perform other duties assigned as needed

Requirements

• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
• 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 a plus
• Experience managing projects a plus
• Clinical/medical device experience highly preferred

Functional and Technical Competencies

• 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
• 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