Clinical Research Leader

Clinical Research Leader

Summary:

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.

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
• May serve as the primary contact for clinical trial sites (e.g. site management)
• 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
• Responsible for 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
• May 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
• 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)
• Responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
• Track and manage assigned project budgets to ensure adherence to business plans
• Support clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy
• Develop a strong understanding of the pipeline, product portfolio and business needs
• May serve 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
• May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
• Perform other duties assigned as needed
• Generally manages work with limited supervision, dependent on project complexity Independent decision-making for simple and more advanced situations but require minimal guidance for complex situations

Education:

Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required

Experience:

• 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
• 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
• 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 presentation and technical writing skills