Clinical Project Manager I

The Clinical Project Manager I is responsible for overseeing the operational aspects of clinical trials, ensuring adherence to SOPs, GCP/ICH guidelines, and regulatory requirements. They lead a multifunctional study management team and serve as the primary point of contact for client study teams. The role involves end-to-end execution of clinical trials, effective communication of study progress, and efficient resourcing and financial management. The Clinical Project Manager I also plays a key role in project analysis and management, leadership development, and supporting business development efforts. Qualifications include a bachelor's degree, in-depth knowledge of clinical study management, and expertise in study management and clinical research.

• Develop study plan outlining planning, execution, and closeout milestones
• Develop a study management plan in conjunction with the Director, Clinical Operations, and sponsor representative(s) outlining target KPIs, risk assessment, and contingency planning
• Lead multi-disciplinary Study Management Team
• End-to-end management of clinical studies to ensure appropriate resourcing and timely and high-quality delivery by all functional areas
• Assist in screening, selection, and management vendors in accordance with contractual timelines, sponsor specifications, quality, budget, and GCP
• Develop and monitor study metrics to continuously assess study progress
• Act as the primary point of contact between Science 37 and sponsor project team
• In collaboration with the study management team and Marketing, develop a robust recruitment and retention data-driven strategic plan including risk assessment and contingency planning
• Identify critical project success factors for tracking, analysis, and reporting including impact and probability of project risks
• Monitor and track study status, timelines, and budget expenditures; identify opportunities and recommend implementation plan for efficiency measures
• Accountable for overall study budget, ensuring that all invoices are paid, issues are addressed, and revenues are booked in a timely manner
• Ensure timely data entry, query resolution, and prompt resolution of data issues
• Coordinate assignment of needed resources for study conduct and completion with functional area leaders; ensure appropriate staffing to accomplish project goals within budget
• Identify out-of-scope work and report the scope change process to leadership
• Responsible for review of study budget, expense reports, and financial records (invoicing/units/expenses) in conjunction with appropriate project team members
• Ensure that study activities are properly tracked and entered into the company's time tracking/project management/resource planning software tool in a timely manner
• Ability to analyze data and information to derive conclusions and drive critical decision-making
• Accountable for development, oversight, and delivery of team training for specific projects
• Apply expertise in day-to-day Clinical Operations activities, collaborate with internal and external cross-functional team members to develop study documents and manuals, including protocols, ICFs, manuals, presentation decks, risk plans, etc.
• Determine needed project processes and train study teams; maintain study team knowledge and application of project processes
• Establish and communicate team performance expectations and guidelines
• Manage performance of external service providers as required
• Provide performance evaluation input for Science 37 project team members and service providers
• Participate in the development and review of departmental SOPs, guidelines, intradepartmental procedures, and other continuous process improvement programs, as assigned
• Support the development of project proposals by participating as Subject Matter Expert (SME) in internal and external meetings; represent Science 37 in sponsor and vendor relationships as required
• Understand customer needs and appropriately influence decision-making
• Bachelor's degree or equivalent applicable experience required; advanced degree or equivalent clinical research experience preferred
• Minimum of 2 years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience required
• Medical and scientific knowledge 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 in which it operates.

• Bachelor's degree or equivalent applicable experience required
• Advanced degree or equivalent clinical research experience preferred
• Minimum of 2 years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience required
• Medical and scientific knowledge 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 in which it operates.

• On-time and on-budget delivery of clinical studies
• 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
• 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, query resolution, and resolution of data issues
• Assignment of needed resources for study conduct and completion
• Review of study budget, expense reports, 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
• Support in the development of project proposals
• Understanding of customer needs and influencing decision-making
• Bachelor's degree or equivalent applicable experience required
• Minimum of 2 years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience
• Medical and scientific knowledge preferred
• 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)