CLINICAL STUDY SPECIALIST

Currently, one of our clients in Collegeville, PA is seeking a Clinical Support Specialist to join their team immediately for an exciting 6 month assignment!Candidate will provide operational support to all clinical studies conducted in NA for delivery of assigned studies or programs on time and within budget through both internal and external sourcing strategies. Responsible for accuracy of database systems. Contribute to compilation of study feasibility. Serve as an operational 'single point of contact'. Collaborate with CDMA and other key matrix partners. Adhere to the CO model, partner and interface with TA and Clinical Operations teams to ensure milestones and timelines are met for a study/project. Adhering to the CO model, oversee tracking in study/project spends and matrix with budget coordinators. Manage study/project budgets ensuring payments/invoices maintained by CSS/CSC staff are submitted meeting SM agreed budget calendar timelines. Manage study/project budgets ensuring standardized spreadsheets are updated meeting SM agreed budget timelines. With direction from Sr. Clinical staff, develop DRAFT overall study and per patient/site budgets utilizing the Time.
REQUIREMENTS
Experience:2 years or more of formal post-high school. 5 years of experience in clinical development experience or equivalent work experience. Proven ability to work effectively within interdisciplinary teams. Advanced computer proficiency in a variety of Clinical Study databases and software applications. In-depth knowledge of study processes and procedures including related functional areas and FDA regulations. Ability to work on complex or multiple project assignments. Demonstrate ability to manage projects and assignments with minimal supervision. Exhibit customer service orientation and interpersonal skills.