The primary responsibilities of this role, Clinical Research Manager, are to:
Manage and oversee the operational execution of Over The Counter (OTC) Sun Care and Foot Care studies in humans, such as the guidance and management of internal and external CRAs; Manage and oversee the activities of CROs and other operational contractors and third parties involved in the conduct of OTC Consumer Health studies, ensuring that all applicable guidelines are followed (i.e. ICH Guidelines, GCP and SOPs); Select and qualify study sites, conduct pre-study visits, study initiations, carry out interim monitoring visits with the timely completion of reports and oversee these activities; Develop or contribute to protocol development as necessary; Manage timelines and budgets of the assigned studies.
Who you are
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, We seeks an incumbent who possesses the following:
Bachelor’s degree in Life Sciences, Health Sciences or other related field, or professional Nursing/Medical qualification; Minimum of five (5) to six (6) years’ experience in Clinical Biomedical Development; Excellent written, verbal, interpersonal, and organizational skills; Working knowledge in tracking clinical study costs against determined budget; Knowledge of, and adherence to, ICH/GCP Guidelines as well as appropriate guidelines for clinical monitoring; Broad knowledge and cross functional understanding of clinical trial methodology and logistics; Demonstrated team player with the ability to also work independently to accomplish objectives within timelines established by the Clinical Trial Manager and/or Project Teams; Ability to work in a matrix organization.
Two (2) to three (3) years’ experience managing clinical studies operations.