If you are a Clinical Study Manager with experience, please read on!
The Clinical Study Manager is responsible for the operational management and oversight of all aspects of a clinical study. This may include managing single-center or multi-center clinical studies. The CSM will work closely with the VP of Medical Affairs, clinical study Medical Monitor, Compliance, Regulatory/QA, etc, as applicable, as well as other cross-functional team members/clinical CRO and staff to ensure successful completion of all clinical activities/project deliverables within the required time frame and budget.
Top Reasons to Work with Us
- Well Established Leader - Multiple Industry Awards
- Excellent Compensation Package (110- 135k Base + BONUS)
- Challenging work- Great Team and Leadership
- Vacation/PTO- Generous Benefits (Medical, Dental, Life, Flex Benefits)
What You Will Be Doing
-Planning, executing, and managing clinical projects and service laboratories.
-Protocol development and/or review to assure compliance with regulatory requirements and alignment with study objectives.
-Monitoring clinical trial conduct at external site(s).
-Coordinating with medical facilities and clinical research organizations to support sample acquisition activities for R&D and service laboratory projects.
-Initiate, coordinate, and take responsibility for developing supporting documents (such as informed consent, case report forms, etc) related to study conduct, including source documentation, monitoring and study guidelines, and training materials to assure compliance with regulatory requirements and alignment with study objectives.
-Conduct remote data monitoring and on-site visits (training, monitoring, close-out) in accordance with Federal regulations, ICH Good Clinical Practices guidelines and standard operating procedures.
-Establish professional rapport and frequent communication with clinical study site personnel.
-Generation of study reports.
What You Need for this Position
-Degree in health-related science (M.S. , PHD. B.S.) and/or nursing degree (RN), and/or pharmacy degree
-At least 5 years of clinical operations work experience or related industry experience and a working knowledge of GCP/ICH guidelines and medical device/in vitro diagnostic clinical development process.
- Experience in immunology preferred.
-Lesser duration of clinical operations work may be acceptable depending on the candidate.
-Management of international clinical studies is a plus
So, if you are a Clinical Study Manager with experience, please apply today!
Applicants must be authorized to work in the U.S.
Email me to apply for this position