Senior Clinical Project Manager

Role Description

The Senior Project Manager position is responsible for taking a leadership role in facilitating the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, assessment of resource needs and utilization, and risk identification/mitigation. This position ensures that ongoing projects have existing project plans as required by the established Standard Operating Procedures (SOPs) and ensures that project progress status is properly tracked and reported, and issues are promptly identified and resolved.

• Define project scope and estimate budgets.
• Plan, direct, and lead project activities.
• Manage resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities.
• Report project progress status to Everest internal management and clients.
• Assist in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP).

Qualifications

• Bachelor of Science or Master of Science in life sciences or health-related field.
• Over 10 years of experience in clinical research and development within a pharmaceutical, biotechnology, or Clinical Research Organization (CRO) setting.
• Minimum of 7 years of clinical pharmaceutical industry experience including demonstrated skills and competency in clinical project management tasks.
• Oncology experience is required.
• Knowledge of clinical research process inclusive of Phase I trials through regulatory submission.
• Previous experience as a clinical trial monitor with experience in initiating, monitoring, and closing out clinical trials is desirable.
• Knowledge and understanding of ICH guidelines, FDA, Health Canada, and EMA regulations.
• Demonstrated understanding of cross-functional processes including site selection, study start-up, clinical operations, statistics and statistical programming, data management, subject randomization and drug supply management (IWRS), data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing.
• Demonstrated leadership abilities, including setting goals for others and driving to achieve them in accordance with allocated resources, timelines, and budgets.
• Solid financial acumen including the ability to define scope and estimate budgets, and plan and manage projects.
• Excellent interpersonal and oral and written communication skills.
• Strong ability in problem-solving including conflict resolution.

Requirements

• Manage projects from initiation through closure for full scope regional and global projects.
• Facilitate project planning, identification of tasks and deliverables, and assessment of resource needs and utilization.
• Perform project progress tracking using project planning and tracking methods, tools, and software.
• Prepare project status reports and maintain accurate and current details.
• Conduct project progress status meetings with individual project teams periodically.
• Function as a meeting facilitator for meetings involving various internal and external participants.
• Act as the project management lead interfacing with clients to drive project delivery, communication, problem solving, and issue management.
• Coordinate activities between Everest and trial Sponsors, and with various supporting groups or vendors when necessary.
• Proactively track and manage project tasks against timelines and budgets.
• Communicate project action items and key decisions through timely minutes and follow-up documentation.
• When required, perform clinical trial planning, management, and site oversight from the initiation of a trial to its closure.
• Generate new sales leads by developing trust-based relationships with client counterparts.
• Be available to travel, up to 20%, including international travel.

Benefits

• Medical, dental, and vision coverage.
• Life & AD&D insurance.
• Short- and long-term disability.
• Tuition reimbursement.
• Fitness reimbursement.
• Employee assistance program (EAP).
• 401(k) retirement plan.
• Generous paid time off and sick leave.
• Opportunity to earn a performance-based bonus.