Seasoned Drug Development Expert, skilled in managing teams and programs toward the approval of new pharmaceuticals agents / indications.
Essential duties and Responsibilities
• 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 Luitpold 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 outside vendors including consultants and CRO’s with respect to the clinical trials
• Prepare and review protocols, 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
• All other tasks, activities and responsibilities as deemed necessary by the Head of Clinical Research and Development.
• Ensures that clinical trial safety is appropriately forwarded to the Pharmacovigilance Group for processing.
• Investigator Payments
• Study tracking
• Study Files
• Position based in the Norristown, PA office.
• Reports to the Head of Clinical Research and Development.
• Overnight travel required.
• Bachelors’ degree required preferred degree in the Biological / Health Sciences. Minimum 5 years Pharmaceutical industry
experience required. Experience in clinical development as a Clinical Research Associate a plus.
• Ability to travel without supervision. Ability to multi-task and successfully handle multiple priorities simultaneously.
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.