Overall responsibility

The Project Management Manager (PM Mgr) will be responsible for operational planning, scheduling, and managing of deliverables associated with sponsor protocols. The PM Mgr will work with sponsor requirements utilizing the project-specific Statement of Work, protocols and other data to identify requirements for planning, budgeting, estimating enrollment requirements and forecasting. The PM Mgr will be responsible for the operational management and oversight of clinical investigator sites of SUMMIT. The PM Mgr will monitor site performance, developing a standard method for the multi-site management system and ensure the management system is deployed to Summit site partners. The PM Mgr will ensure successful completion of all clinical activities under the responsibility of SUMMIT investigator sites within the required timelines. The PM Mgr will be the primary contact for the client (Sponsor and CRO by delegation), 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 Mgr will be responsible for directly managing performance and metrics of PM staff.

The PM Mgr 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
• Assist with the development and implementation of company-wide processes and procedures to include training and management of PM staff

Requirements:

• Bachelor’s degree (Minimum)
• At least 5 years of project management with clinical research experience, (clinical trial management in pharma, biotech, or CRO setting), with significant experience in clinical trial planning and execution
• Strong ability to plan, develop, and manage multiple projects
• Strong knowledge and understanding of ICH Guidelines, FDA regulations, and GCPs
• Strong project management skills (synthesis, organization, excellent reporting skills)
• Excellent written and verbal communication. Capable of developing precise, accurate written and verbal communications to provide management with status updates, and escalating risks as appropriate
• Ability to effectively work with multiple organizations in a professional manner
• Ability to manage and supervise others
• 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
• Strong computer skills (expert efficiency in Microsoft Office products e.g. Word, Excel Outlook and Power point)

The requirements listed above 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.

Supervisory Responsibilities:

The PM Manager will be responsible for the management and oversight of the Project Management Team.

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:

• GCP 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.