Clinical Project Manager II

The Clinical Project Manager II is responsible for overseeing the on-time and on-budget delivery of clinical studies, ensuring the highest quality standards. They lead a multifunctional study management team and are accountable for planning, executing, and closing out clinical trials in compliance with SOPs, GCP/ICH guidelines, and regulations. The Clinical Project Manager II serves as the main point of contact for client study teams and is responsible for effective communication of study progress, issue resolution, and resource and financial management. They also play a key role in project analysis, management, leadership, and business development.

• Develop study plan outlining planning, execution, and closeout milestones
• Develop study management plan in conjunction with the Director, Clinical Operations, and sponsor representative(s)
• Lead multi-disciplinary Study Management Team
• Manage clinical studies to ensure appropriate resourcing and timely and high-quality delivery
• Assist in screening, selection, and management of vendors
• Develop and monitor study metrics to assess study progress
• Act as the primary point of contact between Science 37 and sponsor project team
• Develop recruitment and retention strategic plan
• Identify critical project success factors for tracking, analysis, and reporting
• Monitor and track study status, timelines, and budget expenditures
• Ensure timely data entry and resolution of data issues
• Coordinate assignment of needed resources for study conduct and completion
• Identify out-of-scope work and report scope change process
• Review study budget, expense reports, and financial records
• Ensure study activities are properly tracked and entered into the company's software tool
• Analyze data and information to drive critical decision-making
• Develop, oversee, and deliver team training
• Collaborate with internal and external team members to develop study documents and manuals
• Establish and communicate team performance expectations and guidelines
• Manage performance of external service providers
• Participate in development and review of departmental SOPs and guidelines
• Support the development of project proposals
• Understand customer needs and influence decision-making
• Demonstrate expertise in study management
• Adapt to a rapidly changing work environment and manage competing priorities
• Have extensive knowledge of clinical research and the drug development process
• Possess medical and scientific knowledge
• Have global experience

• Bachelor's degree or equivalent applicable experience required
• Advanced degree or equivalent clinical research experience preferred
• 5+ years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience required
• 3 years of Project Management experience in Clinical Research
• Medical and scientific knowledge preferred
• Global experience preferred
• Expertise in study management - Demonstrates ability to successfully manage people and multiple clinical studies. Proactive problem-solving abilities and follow-through.
• Knowledge of field organizational strategies - Ability to adapt to a rapidly changing work environment, managing competing priorities. Successful decentralized team management and situational responsive decision-making.
• Extensive knowledge of clinical research - Understands the drug development process, clinical research industry, and the relevant environments.

• On-time and on-budget delivery of clinical studies
• Highest quality standards
• Broad therapeutic knowledge
• Leading the multifunctional study management team
• Planning, solutioning, recruiting, executing, and close-out of clinical studies
• Compliance with corporate and project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, and other applicable regulations
• Single point of contact to client study teams
• Delivery of project objectives on-time and on-budget
• Effective and timely internal and external communication of study progress, issues, and plans for resolution
• Efficient resourcing and financial management of studies
• Development of study plan and study management plan
• Monitoring and tracking study status, timelines, and budget expenditures
• Timely data entry and resolution of data issues
• Assignment of needed resources for study conduct and completion
• Review of study budget and financial records
• Analysis of data and information to drive critical decision-making
• Development, oversight, and delivery of team training
• Collaboration with internal and external cross-functional team members
• Performance evaluation input for project team members and service providers
• Participation in development and review of departmental SOPs and continuous process improvements programs
• Support in the development of project proposals
• Understanding of customer needs and influencing decision-making
• In-depth knowledge of pharmaceutical/biotech-sponsored clinical study management
• Project management experience in clinical research
• Medical and scientific knowledge
• Global experience
• Expertise in study management
• Knowledge of field organizational strategies
• Extensive knowledge of clinical research
• Team management and collaborative capabilities
• Interpersonal savvy
• Strong motivational and influence skills
• Strong communication and presentation skills
• Computer skills
• Financial skills
• Practices professionalism and integrity in all actions
• Leadership capabilities
• Ability to travel up to 20%
• Ability to communicate in English (both verbal and written)