Nature and Scope
Seasoned Drug Development Expert, skilled in managing teams and programs toward the approval of new pharmaceuticals agents / indications.
Essential Duties and Responsibilities
- Functional/line management of in-house clinical study team.
- Manage the investigative sites by discussing and resolving protocol, budget, enrollment and staffing issues.
- Ensure that project status information is collected and distributed to the relevant members of the American Regent team.
- Direct and interact with the Clinical Research Associates (CRAs) and Project Coordinator to ensure that the project is properly monitored, and data is accurate and collected uniformly between the various investigative sites.
- Direct/manage outside vendors including consultants and CRO’s with respect to the clinical trials.
- Assist in the preparation and review of protocols, case report form design, clinical study reports, and other study information.
- Prepare and review SOP’s and ensure that procedures are appropriately and consistently applied to all study activities.
- Responsible for the successful completion and regulatory rigor of all clinical studies.
- Responsible for the timely completion of all clinical studies. · Responsible for adequate training of clinical staff.
- Ensures that clinical trial safety is appropriately forwarded to the Pharmacovigilance Group for processing.
THIS IS A REMOTE POSITION
- Investigator payments.
- Study tracking (i.e. CTMS, excel spreadsheet, MS Project proficiency).
- Study files (i.e. eTMF proficiency). · Development, tracking and ongoing maintenance of clinical study budgets.
- Oversee subject recruitment and enrollment for each assigned clinical study.
Education Requirements and Qualifications:
- Bachelors’ degree required preferred degree in the Biological / Health Sciences.
- Minimum 5 years Pharmaceutical industry experience required.
- Minimum 5 years having held the position of Clinical Project Manager in a pharmaceutical company, managing phase 2 & 3 clinical trials required. Experience in clinical development as a Clinical Research Associate a plus.
- Extensive expertise of ICH-GCP and a thorough comprehension of the drug development process.
- Clinical trial regulations, such as those of the US FDA, EMEA, DCGI, and others, are well-understood. Ability to travel
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact John Rossini, Talent Acquisition Director at 631-690-7201 or email at HRTalentAcquisition@americanregent.com