The Sr. Clinical Study Manager (Sr. CSM) organizes and facilitates the overall planning, coordination, tracking and general performance of clinical studies that support the Clinical Development Plan. The Sr. CSM is responsible for ensuring clinical study quality/consistency of performance and in conjunction with the Clinical Leader and all other Team members is responsible for overall timeline adherence and performance against plan of the clinical study. A critical component of the position is the peer management and/or support of and coordination with contract research organization personnel (CROs), consultants, contractors, and other Purdue colleagues to ensure adequate resource volume and quality is maintained on the studies for which the Sr. CSM is responsible. At times, business travel will be necessary.
BS/BA in a health-care or science related field with a minimum of 7+ years of related experience in a pharma or CRO company.
Required Experience & Technical Requirements
Has demonstrated knowledge of, and competence in, application of FDA/GCP/ICH guidelines.
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
- Has demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials.
- Has demonstrated the knowledge and ability to effectively manage a clinical trial with minimal supervision.
- Has demonstrated the ability to lead cross functional teams; excellent organization, negotiation and team motivation skills are essential.
- Must possess the ability to multi-task and effectively prioritize in order to ensure clinical trial goals.Brief Description/Overview:
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com. No hard copy resumes will be considered.
Purdue Pharma L.P. - 2 years ago