[Remote] Clinical Research Leader

Note: The job is a remote job and is open to candidates in USA. reputed company, is seeking a Clinical Research Leader to manage and support clinical trials reputed company the Clinical R&D Department. This role involves ensuring compliance with study milestones and fostering relationships across the organization.

Responsibilities

• Serve as a Clinical Research Leader reputed company the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones
• reputed company/execution of feasibility, selection, set up, conduct and closure of a clinical trial reputed company 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)
• reputed company 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/reputed company of ordering, tracking, and accountability of investigational products and trial materials
• reputed company and collaborate with site personnel, IRBs/reputed company, contractors/vendors, and company personnel
• reputed company 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 reputed company monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or reputed company out visits based on study need
• May contribute to the development and delivery of appropriate global evidence reputed company strategies (EGS) and evidence dissemination strategies (EDS) reputed company 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 reputed company 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, reputed company budget and in compliance with regulations and SOPs)
• Responsible for communicating business reputed company 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/ reputed company bodies to drive support of the clinical and regulatory strategy
• reputed company 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 reputed company Federal, State, local and company regulations, policies and procedures
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
• reputed company 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 reputed company situations

Skills

• 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
• Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, reputed company 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 reputed company clinical/ surgical research setting, on time, reputed company budget and in compliance to SOPs and regulations
• Strong presentation and technical writing skills
• 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

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