Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. Backed by venture investors such as Glynn Capital, Google Ventures, Redmile Group, dRx Capital and Lux Capital, we are revolutionizing the clinical trial industry one patient at a time.
The Clinical Study Leader (CSL) is a member of Clinical Operations department accountable for on-time and on-budget delivery of clinical study(ies) at the highest quality standards.
The Clinical Study Leader will lead the multifunctional study management team within a matrix environment. The study management team is collectively responsible for planning, solutioning, recruitment, execution, and close out of clinical studies, within the scope of the client agreement. In doing so, the Clinical Study Leader is responsible for the cross-functional team’s compliance with corporate and project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines and other applicable federal (FDA) and state regulations.
The Clinical Study Leader is the principal liaison with the client study teams and is responsible for end-to-end execution of clinical trials to ensure effective and timely internal and external communication of project progress, issues, and plans for resolution of those issues. The Clinical Study Leader is also responsible for efficient resourcing and financial management of studies under his/her supervision. In this capacity the Clinical Study Leader will have line management responsibilities.
Duties include but are not limited to:
Project Guidelines and Communication:
- Develop project plan outlining planning, execution, and closeout milestones.
- Develop a project management plan in conjunction with the Director of 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 project metrics to continuously assess study progress.
- Act as the primary point of contact between Science 37 and sponsor project team.
- In collaboration with study management team, develop a robust recruitment plan including risk assessment and contingency planning.
Project Analysis and Management
- Identify critical project success factors for tracking, analysis and reporting including impact and probability of project risks.
- Monitor project status, timelines, and budget expenditures; identifies opportunities and recommend implementation plan for efficiency measures.
- Coordinate assignment of needed resources for project conduct and completion with functional area leaders; ensure appropriate staffing to accomplish project goals within budget.
- Identify out-of-scope work and reports the scope change process to leadership.
- Responsible for review of project budget, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members.
- Manage clinical research coordinators and their activities on each project.
- Ensure that study activities (personal and those of the Clinical Research Coordinators) are properly tracked and entered into the company’s time tracking/project management/resource planning software tool in a timely manner.
- Accountable for development, oversight and delivery of team training for specific projects.
- Determines needed project processes and trains project teams; maintains project team knowledge and application of project processes.
- Establish and communicate team performance expectations and guidelines.
- Mentor and assist in coaching/training Clinical Research Coordinators.
- Conduct performance reviews, calibration sessions and feedback discussions for clinical research coordinators. Perform competency assessments across his/her team and implements and monitors development plans with direct reports.
- Manage performance of external service providers as required.
- Provide performance evaluation input for Science37 project team members and service providers.
- Participate in development and review of departmental Standard Operating Procedures (SOPs), guidelines, intradepartmental procedures, and other continuous process improvements programs, as assigned.
- Support the development of project proposals by participating as Subject Matter Expert (SME) in internal and external meetings. Represent Science37 in sponsor and vendor relationships as required.
- Bachelor’s degree required. Advanced degree or equivalent clinical research experience preferred.
- 8+ years of pharmaceutical-sponsored clinical trials project management experience or equivalent applicable experience.
- Medical and scientific knowledge preferred.
Skills and Competencies
- Expertise in project management - Demonstrated ability to successfully manage people and projects. Proactive problem-solving abilities and follow-through.
- Knowledge of field organizational strategies - Ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making.
- Extensive knowledge of clinical research - Understands the drug development process. Knowledgeable about the critical elements for success in clinical trials, with a history of participation in and contribution to these activities. Ability to review protocols and assess the risks of programs and projects.
- Team management and collaborative capabilities - Demonstrated experience in building and guiding organizational teams. Commitment to collaboration, within and across departments. Leverages each team member’s unique background and perspective to achieve team goals while providing clear direction and accountabilities.
- Interpersonal Savvy – Understands interpersonal and group dynamics and reacts in an effective and tactful manner. Has a range of interpersonal skills and approaches with ability to select a best-fit approach.
- Strong motivational and influence skills – Ability to motivate, influence and guide team members and direct reports; gains commitments from others.
- Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, project team member and internal Science37 relationships. Ability to conduct effective presentations.
- Computer skills - Working knowledge of MS Office suite and Google applications. Able to generate business correspondence, create forms and generate reports as required. Willingness to gain expertise in the use of propriety software.
- Practices professionalism and integrity in all actions - Demonstrated commitment to teamwork, cooperation, self-control, and flexibility in all areas of work.
- Leadership – Communicates and exhibits leadership behavior consistent with the company-wide keystone focus. Ability to have difficult/crucial conversations.
- Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.
- Ability to communicate in English (both verbal and written).
The incumbent reports to the (Senior) Director of Clinical Operations, who will assign projects and provide general direction and guidance. Incumbent is expected to perform duties and responsibilities with minimal supervision.
- Clinical Research Coordinators
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Enjoy healthy catered lunches, snacks and beverages, and top-notch equipment such as the latest Macbook Pro, 4k monitors, and adjustable standing desks. Submit your resume to apply!