Clinical Research Project Manager, Evergreen (Remote)

JOB SUMMARY

The Project Manager works collaboratively with key stakeholders to review study requirements and response assessment criteria to assure execution of  study start-up.  In addition, this role will conduct key analysis and project management, along with close-out activities according to the Customers’ and Elligo’s’ contractual agreements. 

RESPONSIBILITIES

The Project Manager is responsible for managing definitive project plans and establishing and assuring the execution of project reporting schedules.  Additionally, this role works to establish and assure the execution of project reporting schedules and assure that all stakeholders receive all project updates per the established schedule.  Another vital role that this position will be responsible for is assuring that the appropriate project information is communicated to the project teams, sites and company/sponsor representative(s).

Key Responsibilities

Performs Project Analysis and Management by:

• Identifying critical project success factors for tracking, analysis and reporting
• Determining resources required for project completion and communicating needs to appropriate departmental managers
• Ensuring projects are executed in accordance with Good Clinical Practice (GCP), relevant Standard Operating Procedures (SOPs) and regulatory requirements
• Collaborating with department leaders to ensure administration of appropriate training of those involved with the project 
• Coordinating activities and deliverables of all study team members
• Developing contingency planning and risk mitigation strategies to ensure successful project delivery
• Overseeing study documentation and ensuring project records remain inspection ready
• Maintaining current study information in databases and systems as required
• Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, along with pass-through cost management
• Demonstrating of a thorough understanding of the project contract and totals needed for monthly revenue reporting

Provides Project Team Leadership by:

• Leading by example with professional and collaborative conduct
• Developing and delivering team project training
• Establishing team performance metrics, expectations and guidelines
• Analyzing team performance for consistency/quality within established project guidelines
• Serving in the capacity of line manager for project team members as needed
• Collaborating with the departmental managers for team coaching/mentoring

Manages customer relationships by:

• Effectively communicating project specific reports to external stakeholders in accordance with strategic objectives of the organization
• Hosting regular project review meetings with customer(s) to share key findings and current performance
• Acting as a liaison between customer(s) and Elligo’s Research Operations team
• Initiating and maintaining collaboration with the appropriate individual(s) and/or department(s) within the client’s organization
• Building positive customer relationships with the goal of acquiring net new awarded projects

QUALIFICATIONS AND EDUCATION REQUIREMENTS 

• BS/BA in Life Science or related discipline
• 5+ years project management or equivalent experience
• Experience with clinical trial management systems
• Proven expertise executing project plans, timelines and budgets
• Ability to travel as needed

Preferred

• Previous project management experience in a clinical research setting preferred
• Previous GCP training and certification and knowledge of ICH guidelines and other applicable regulatory requirements preferred

Key Skills and Abilities

• Demonstrated ability to work collaboratively with cross functional departments/groups 
• Ability to independently and collaboratively create and manage project management plans related to the job requirements
• Exceptional management, leadership, judgement and organizational skills
• Effective verbal and written skills 
• Strong interpersonal skills with attention to detail 
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems
• Strong organization/prioritization skills for the management of multiple concurrent projects and tasks
• Willingness to embrace new technologies
• Recognized meticulousness related to detailed tasks, such as the management of reports, processes and project management

WORKING CONDITIONS

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

WORKING SCHEDULE

Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand.

TRAVEL REQUIREMENTS

Regular local and regional travel as required for this position (less than 25%)

Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.