Clinical Research Leader

Responsibilities

• Serve as a Clinical Research Lead to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Biosense Webster.
• Oversight/execution of feasibility, selection, set up, conduct and closure of the trial within the allocated countries, in accordance with ICH-GCP, applicable legislation and Company Standard Operating Procedures.
• Serves as the main 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 direction.
• Ensure trial registration from study initiation through posting of results and support publications as needed.
• Management/oversight of ordering, tracking, and accountability of investigational products and trial materials.
• Communicate and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
• Lead all aspects of development and execution of Investigator agreements and trial payments.
• Leads 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 provide on-site procedural protocol compliance and data collection support to the center.
• Contribute to the assessment of the literature and to the interpretations and disseminations of all evidence generated.
• Responsible for clinical projects, through partnership with the study core team leading to delivery of clinical project commitments.
• Supervise and manage assigned project budgets to ensure adherence to business plans.
• Support clinical scientific discussions with regulatory agencies to drive support of the clinical and regulatory strategy.
• Serve as the clinical representative on the Product Development team.

Qualifications

• Minimum of a bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required
• Masters degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
• PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 3 years clinical research experience is required
• Experience with project/team leadership is required
• Relevant industry certifications are preferred (examples may include; CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
• Medical device experience highly preferred
• CRO experience and site management and clinical site monitoring are assets
• Experience delivering presentations and writing clinical reports is preferred