Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Clinical Study Manager
The role is responsible and accountable for managing and overseeing the planning, preparation, conduct and reporting of all types of Efficacy, Safety, Real-World Data, Claims and Consumer Research Studies (e.g. Organoleptic Testing, Consumer Insight Tests, Scan Panels, Consumer Panels etc.) in humans in ASEAN and China in which a subject is physically exposed to a Bayer Consumer Health (BCH) product or active product ingredient from protocol development, obtaining third party proposals and third party contracting to final study report available.
YOUR TASKS AND RESPONSIBILITIES:
- This function works closely with other functions within Medical & Clinical. As the operational study responsible and accountable the incumbent supports the preparation of study budgets and timelines, is responsible for the preparation and execution of Clinical Trial Application to competent authorities and ECs/IRBs, and provides support to all concerned internal functions e.g. Medical to prepare for and to gain the necessary governance approvals.
- Operational expert for the preparation, set-up and conduct of efficacy, safety, Real-World Data studies, 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 regarding its operational aspects.
- Third party and study site identification, qualification and contracting. This includes the responsibility and accountability to ensure that all applicable guidance’s including are followed in all aspects of the studies., however not limited to ICH Guidelines, GCP and SOPs
- 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), survey- and subject reported outcome questionnaires, Monitoring as well as Data Management Plans, Audit Checks, and Statistical Analysis Plans.
- Oversees administrative activities, maintenance of study documentation including preparation and collection of competent authority and IRB/EC review and approvals.
- Perform study initiation, interim monitoring visits with the timely completion of reports. Closing 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.
- Ensure timely availability of study supplies, subject recruitment and smooth conduct of subsequent operations, including data flow.
- Account for and reconcile all used and unused trial supplies.
- Supports the preparation of study budgets and timelines, and oversees and manages the same, which includes processing of invoices from external vendors in the applicable system (e.g. YOurDocs) and tracking of these against the approved study budgets.
WHO YOU ARE:
- Bachelor’s or related degree in Life Sciences, Health Sciences or related field, or a professional nursing or medical qualification.
- 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 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.
- Team player with ability to work independently to accomplish objectives within timelines established by the Project Teams, and the ability to work in a matrix organization
Location: Kuala Lumpur
Reference Code: 299651
Functional Area: Clinical Development & Operations