Clinical Study Manager - OTC/Consumer Health
Your tasks and responsibilities
1. Operational expert for the preparation, set-up and conduct of efficacy, safety, claims and consumer research testing (which includes organoleptic testing, consumer insight tests, scan and consumer panels in which a subject is physically exposed to a BCH product or active product ingredient) from involvement in development of study protocol to final study report. As such, the Clinical Study Manager contributes to the Study Concept development with regard to its operational aspects.
Who you are
3. Oversees and manages the process of, and partners with CROs on the conduct of studies which also includes development and processing of all relevant study documentation including Subject Information and Consent Forms, Case Report Form (CRF), subject reported outcome questionnaires, Monitoring as well as Data Management Plans, Audit Checks, and Statistical Analysis Plans.
4. Oversees administrative activities, maintenance of study documentation including preparation and collection of competent authority and IRB/EC review and approvals.
5. Perform study initiation, interim monitoring visits with the timely completion of reports. Closing down or oversee closing down of study sites on completion of the trial including archiving study documentation and correspondence This includes as needed oversight of activities conducted by internal and external CRAs and/or CROs as they are involved in study conduct.
6. Ensure timely availability of study supplies, subject recruitment and smooth conduct of subsequent operations, including data flow.
7. Account for and reconcile all used and unused trial supplies.
8. Supports the preparation of study budgets and timelines, and oversees and manages the same, which includes processing of invoices from external vendors in YOurDocs and tracking of these against the approved study budgets.
WHO YOU ARE
• Education: Bachelor's or related degree in Life Sciences, Health Sciences or related field, or a professional nursing or medical qualification.
• Experience: Minimum of 3-4 years' experience in clinical biomedical development, with 2-3 years' experience in the field of monitoring as a CRA, preferably with experience of multi-national clinical studies. Experience as clinical study project manager is preferred.
Excellent written and verbal English communication skills, interpersonal and organizational skills are must.
Good knowledge in in tracking clinical study costs against the budget. Knowledge of, and adherence to ICH/GCP Guidelines, and as well as appropriate guidelines for clinical monitoring are a requirement. Knowledge and cross-functional understanding of clinical trial methodology and logistics.
• Competencies: Team player with ability to work independently to accomplish objectives within timelines established by the Clinical Development Lead and /or Project Teams, and the ability to work in a matrix organization.
Functional Area: [sap_fa_16]
Entry Level: 5