Clinical Research Project Manager

Responsibilities

• Monitor study metrics and site performance using standard study management tools.
• Oversee the individual study progress over duration of each project.
• Direct liaison between sponsors/investigators and the research coordinator or Vice President.
• Contribute to the development and implementation of SOPs, project-specific procedures, and technical guidance documents, patient acquisition plans, etc.
• Direct establishment of clinical and analytical study related protocols and documents, as well as research/clinical data analysis.
• Manage the orders, sample deliveries and supplies required for each study.
• Interface with investigational sites, clinical consultants, and labs.
• Management of research data sites and renewal terms related with each study and CTU functions.
• Direct all aspects of research data generation and analysis including external site clinical studies and internal analytical studies.
• Drive internal communication, including timelines, budget, progress, and project needs for clinical trials to product teams and senior management.
• Interface with ORA, IRB, WMC and other pharmaceutical/hospital research offices

Qualifications

• Education requirement: Bachelor's degree in biology, mathematics, computer science, natural sciences or related areas.
• Licenses or certifications: CITI Technical/Computer Skills
• Ability to use a combination of validated Electronic Data Capture (EDC) systems and/or other internal or commercial software tools and proven ability to learn and apply new software quickly as projects require.
• Familiarity with REDCap preferred.
• Strong IT skills, including excellent knowledge of various software programs and packages including MS Word, Excel, Access.
• Minimum of two years of related professional experience.
• Ability to multi-task and meet established deadlines.
• Ability to work effectively both as part of a project team and independently is essential.
• Excellent oral and written English communication skills.
• Proven experience using data management systems, tools and processes to support multi-site, multimode research studies.
• Ability to effectively apply knowledge and skills in a highly organized fashion while adhering to required guidelines, SOPs and client expectations.
• Good organizational and analytical/problem-solving skills with strong attention to detail.
• Ability to work productively with minimal supervision.
• Ability to attain, maintain and apply a working knowledge of GCPs and applicable SOPs.
• Strong customer focus and excellent interpersonal skills.

Pay

Minimum Salary USD $56,000.00/Yr. Maximum Salary USD $70,000.00/Yr.