Clinical Research Project Manager

The candidate will report to the Vice President of Research. Incumbent will manage all aspects of ongoingresearch studies. Attention to detail, self-starter, well organized as well as good communication skills. Applicant must adhere to Patient confidentially. The individual will be responsible for the oversight of studies conducted out of the clinical trials unit, and as such, will be responsible for contracts, oversee the research coordinators and study progress reports, orders, and other tasks as needed.

• 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.
• Establish research data and work flow plans.
• 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.

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.

Prior experience: Minimum of two years of related professional experience.

Skills:

• 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.

To qualify, applicants must be legally authorized to work in the United States and should not require now, or in the future, sponsorship for employment visa status.