Senior Site Manager

Summary:

The Senior Clinical Research Specialist will be responsible for 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 Senior Clinical Research Specialist within the Clinical R&D Department to support
• execution of 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
• Contribute towards development of clinical trial documents (e.g. study protocol, informed
• consents, CRF, monitoring plan, study manual, investigator brochure, annual reports,….)
• Ensure registration on www.clinicaltrials.gov 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
• 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
• 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
• Contribute to the critical assessment of the literature and to the interpretations and
• disseminations of all evidence generated
• Contribute to 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
• Support project/study budget activities as assigned
• Develop a strong understanding of the pipeline, product portfolio and business needs

Education:

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

Experience:

• Experience in clinical research is required.
• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background a plus.
• Medical device experience highly preferred.