Job Title: Project Manager, Summit Clinical Research

Reports To: Director of Operations

FLSA Status: Exempt

Overall responsibility

The Project Manager will be responsible for the operational management and oversight of clinical investigator sites of SUMMIT. The PM will ensure successful completion of all clinical activities under the responsibility of SUMMIT investigator sites within the required timelines. The PM will be the primary contact for the client (Sponsor and CRO by delegation), and the SUMMIT Investigator Sites, and will be responsible for key study performance information, including start up metrics, enrollment, data collection timelines and quality.

The PM will work in close collaboration with the Executive Management team of SUMMIT

Key tasks:

• Support sites for start-up activities, and contribute to preparation of documentation, including but not restricted to:
• Agreements and budgets
• Preparation of clinical documentation necessary for IRB submission
• Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
• Oversee performance of sites
• Ensure sites are carrying out the study in compliance with study protocol and in accordance with statement of work
• Ensure appropriate tracking and reporting of progress of study including site activation and patient enrollment, from initial planning to end of study
• Identify areas of concern to escalate to SUMMIT management, contribute to action plan to resolve issues, and ensure implementation of action plans
• Support sites to ensure recruitment objectives are met
• Perform regular reporting (meetings and TC) with clients and CROs on SUMMIT activities, in accordance with Statement of work
• Develop and maintain trial specific tools to support patient enrollment metrics
• May follow-up the budget related to the assigned clinical study

Requirements:

• Bachelor’s degree (Minimum)
• At least 5 years clinical research experience, (clinical trial management in pharma, biotech, or CRO setting), with significant experience in clinical trial planning and execution
• Strong knowledge and understanding of ICH Guidelines, FDA regulations, and GCPs
• Strong project management skills (synthesis, organization, excellent reporting skills)
• Capable of developing precise, accurate written and verbal communications to provide management with status updates, and escalating risks as appropriate
• Must be able to identify and take appropriate initiatives to fulfil the requirements of the role, and possess the ability to maintain a high level of productivity with minimal supervision
• Must be able to work in a fast pace environment
• Excellent communication skills, written and verbal
• Strong computer skills (efficiency in word, excel and power point)

Supervisory Responsibilities:

All Summit personnel report to the Chief Medical Office, directly or indirectly.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Language Ability:

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Math Ability:

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills:

To perform this job successfully, an individual should have knowledge of Microsoft Office, Microsoft Excel, Explorer, Google Chrome, Mozilla Firefox, web-based enterprise solutions, and project management software.

Specialized Training:

• CITI training certification
• GCP training certification
• IATA training certification

Certificates and Licenses:

Valid driver’s license and personal auto insurance

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand, walk, sit, use hands, reach with hands and arms, and talk or hear. The employee is occasionally required to stoop, kneel, crouch or crawl, and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, ability to adjust focus, and ability to see color.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is rarely exposed to blood borne pathogens.

The noise level in the work environment is usually moderate.