Sr. Clinical Study Manager (50555673) Stamford, Connecticut
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. PRINCIPAL ACCOUNTABILITIES: The incumbent requires superior written and verbal communication skills, peer management skills and must have a well-defined, effective system for multi-tasking. There are numerous high-level deliverables for which the Sr. CSM is accountable to the study team. Incumbent will conduct the following (or manage the CRO) with minimal supervision in accordance with ICH/GCP/FDA guidelines, Purdue policies/SOPs/WPDs, and protocol specifications: In general, deliverables can be grouped in the following general categories: • Review protocols and advise regarding logistics involved in the conduct of the protocol. • ICF development and review. • Detailed timeline set up and management • Oversee and/or participate in all aspects of study set up through study closure (e.g. Site Selection, Site Start-up and management activities, Monitoring Plan and monitoring, Recruitment Plans and recruitment, CRF retrieval, and study/site close-out activities) • CRO / Vendor training and management (Key communication point for out-sourced studies) • CRA and site training and management (e.g. Investigator Meeting planning/implementation, CRA management and co-monitoring to evaluate protocol-specific monitoring practices). • Create/Manage Study Documentation including confirmation that required documents are archived and available. • Drug safety process set up and follow-through • Audit responses, in coordination with the appropriate team members • Study tracking including the creation/maintenance and review of study status reports (and reporting trends to Project Team) • Lead prospective development of contingency planning for clinical trials execution • Manage budget utilization per study (and potentially per product). • Oversee drug supply requirements and accountability pre-study through completion. • May serve as a Product/Project Team member for complex and/or large projects, acting with a high degree of independence and autonomy. • May be responsible for managing multiple large/complex studies. • May be responsible for mentoring other CSMs or study team members.
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
Technical Requirements Has demonstrated knowledge of, and competence in, application of FDA/GCP/ICH guidelines. • 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.