Sr. Clinical Research Specialist (Medical Device)

Sr. Clinical Research Specialist (Medical Device)

Travel - 20 %

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.

Duties & 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, for the 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)

• 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 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

• 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

• 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

• Responsible for ensuring personal and company compliance with all Federal, State, local and

company regulations, policies and procedures

Experience:

• BS with at least 2-4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience

preferred.

• Previous experience in clinical research or equivalent 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.

Education:

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