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| Job #02220 |
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| About our client |
| Our client is a leading global healthcare supplier and the world’s largest manufacturer of Over-the-Counter (OTC) pharmaceutical and nutritional products for the store-brand market. The company also develops, manufactures, and markets generic prescription (Rx) drugs, Active Pharmaceutical Ingredients (API), and consumer products. |
| Position |
Location |
| Senior Project Manager |
New York |
| Salary |
Reports to |
| Highly competitive package, commensurate with experience |
Clinical Operations Director |
| Responsibilities |
- Organize and manage high-level complex clinical trials
- Oversee/manage study budgets for specified programs
- Facilitate development and execution of clinical trials and confidentiality agreements
- Review statistical analysis plans & data management plans
- Organize and review clinical study reports
- Facilitate/participate FDA correspondence and meetings
- Mentor and provide guidance to other Project Managers within the department
- Develop clinical FDA submission strategies
- Negotiate protocol designs with FDA
- Liaise with CROs and clinical sites to monitor study progress
- Develop strategic clinical trial protocols (increased volume)
- Implement project related decisions and facilitate new development systems
- Liaise between internal departments and external partners
- Organize and attend project team and other necessary management meetings
- Generate internal/external correspondence and compose study documents
- Compile and review monthly progress reports
- Ensure timely progression of project and compliance with rules and regulations
- Organize and participate in Investigator meetings
- Coordinate and facilitate meetings, document QC, teleconferences, clinical supply needs, etc.
- Organize start-up activities, support regulatory submission, and maintain project files.
- Generate and manage pharmacovigilance plans/reports (SAE reporting)
- Facilitate site selection and maintain site evaluations
- Incorporate protocol specific requirement for labeling and packaging of study drugs
- Assist in the compilation of monthly progress reports from CROs
- Review incoming monitoring and enrollment reports
- Audit and periodically co-monitor CROs and investigative sites
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| Requirements |
- Bachelor's or advanced degree in a scientific discipline
- Certification and/or membership in professional associations (ACRP, DIA, SOCRA, etc.)
- 5 -7 years of project management experience in clinical research
- Minimum 2 years of experience as a Clinical Research Associate
- Hands-on experience in working with a pharmaceutical company (dermatology preferred)
- Ability to work independently as well as a team
- Knowledge of MS Office suite
- In-depth knowledge of Federal and Clinical Guidelines/Regulations
- Strong organizational and detail-orientation skills
- Ability to travel – about 15-25%
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