[Hiring] Senior Project Manager @Evolution Research Group

Role Description

The Senior Project Manager is an advanced leader in clinical program management in the clinical research industry, managing, executing, and reporting on clinical study operations. This position provides leadership by building and motivating team members and supports members of the multidisciplinary project team, both internally and externally. When challenges arise, superior problem-solving skills are utilized to navigate solutions, ensuring transparent communication with all stakeholders.

Responsibilities encompass the overall management of a project including:

• Budgeting
• Timeline adherence
• Internal and external communications
• Project deliverables

Acts as the liaison between the sponsor, team members, and sites while managing projects to ensure quality service. This position will be part of the Clinical Operations Team, responsible for planning, executing, managing, and closing projects associated with the company clinical study plans.

Qualifications

• Bachelor degree or equivalent education/degree in life science/healthcare is required
• 8 years of working within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program
• CRO experience is highly desirable
• Experience qualifying & managing external vendors
• Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies
• Experience writing, reviewing, and editing protocols and clinical study reports
• Working knowledge of the FDA submission process

Requirements

• Leads the execution of clinical research projects or programs and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities
• Lead project through its full cycle by assessing requirements including scope, budget, and resource stipulations
• Act as primary liaison between the Company and the sponsor to ensure project launch, conduct, and closeout according to the sponsor and the Company's contractual agreement
• Communicate efficiently among multiple stakeholders: sponsors, cross-functional teams, project vendors, and site staff
• Effectively communicate project progress to stakeholders, generate periodic updates, and prepare formal presentations for required forums
• Coordinates with clinical, marketing, and operations management to identify goals and scope of clinical study projects
• Ensures operational and regulatory integrity of assigned studies and participates in FDA or other regulatory authority inspections, as needed
• Ensures the appropriate development of all documents including but not limited to: study plans, informed consent forms, case report form instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies
• Anticipates and identifies project risks, timeline changes, and analyzes the scope, cost, and resource impact and communicates accordingly
• Develops, manages, and tracks project budget(s) within an established financial framework
• Implements tools, techniques, and processes to enable informed decision making by the project teams, management, and project sponsor as appropriate
• Participates in the review of clinical data for analysis
• Trains, mentors, and coaches junior staff by providing timely and accurate feedback regarding performance on project activities and deliverables
• Ensures all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs)
• Drives a culture of project management excellence in the organization and supports continuous improvement of project delivery practices
• Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations
• Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research
• Attend off-site meetings and conferences, as needed

Company Description