Responsibilities: Currently, one of our top clients is in search of an exceptional Sr. Clinical Study Manager in Irving, Texas. The Senior Clinical Study Manager is responsible for the oversight of assigned clinical studies and associated activities ensuring that studies are executed, conducted and completed, in accordance with corporate goals and objectives, applicable regulations and Standard Operating Procedures (SOPs). The Senior Clinical Study Manager functions with moderate supervision, collaborating with inter and intra company resources to ensure quality performance and that project timelines and needs are being met.
Specific accountabilities:
Evaluate and oversee the activities required to execute, conduct and complete large sized studies, managing to established timelines and corporate budgets
Function as primary liaison for site personnel and internal company personnel in regards to study related topics and/or questions
Negotiate site study budgets and contracts
Collaborate with cross functional team members (e.g., pre-clinical, manufacturing, data management, safety surveillance, biostatistics, and quality assurance)
Manage study start-up activities by developing the protocol, case report forms (CRFs) and study related material including the Informed Consent (IC)
Develop, implement and ensure adherence to the monitoring plan for assigned studies
Kforce (Nasdaq:KFRC) is a professional staffing and solutions firm providing flexible and permanent staffing solutions in the skill areas of technology, finance & accounting, clinical research and healthcare. Backed by approximately our associates and consultants on assignment, Kforce is committed to 'Great People = Great Results' for our valued clients and candidates. Kforce operates with 65 offices located throughout the United States and two offices in the Philippines.
Job Ref#: 2312~NRC~1141613P1~99
Due to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria.
Requirements:
College degree in life/physical sciences or nursing
7+ years of clinical research experience
Previous study management or project management experience at a sponsor or CRO
Ability to assess the inherent risks of a situation, their potential impact on a project and based on this information, independently make timely decisions
Working knowledge and experience with Word, PowerPoint and Excel
Ability to travel minimum of 30%
Strong GCP and regulatory knowledge including FDA and ICH regulations
CareerBuilder - 14 months ago
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