Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. We are seeking a razor-sharp Director of Clinical Operations eager to make an impact within a mission-driven organization changing the world through clinical research. As part of the Science 37 team, you will be responsible for the successful execution of clinical trials in terms of financial management and operational oversight. You will also provide direction within the Clinical Operations department while simultaneously mentoring a growing team of project managers and clinical research coordinators at Science 37. Essentially, the ideal candidate will have the skills and understanding of how a research site functions, as well as knowledge of the use of mobile technology to enhance clinic operations, study participant flow, and study participant experience. Interested? Keep reading!
The Director of Clinical Operations is responsible for the operational oversight of clinical research trials conducted by Science 37. In addition, the Director of Clinical Operations is a member of department’s leadership team, responsible for strategic direction and functional management of
Clinical Operations. This leader will provide direction within the Clinical Operations department while mentoring and developing Metasite Study Leaders and Clinical Research Coordinators at Science 37. This individual will have the skills and understanding of how clinical research is conducted from the sponsor, site, and CRO perspectives. In addition, the Director of Clinical Operations is knowledgeable in the use of mobile technology to enhance operational conduct of clinical studies for study participant and study sponsors. The Director will engage and evaluate performance to assure that Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), regulatory guidelines, and all best practices are followed rigorously and uniformly. The Director will work internally across functions and departments with Science 37 study staff and management, as well as externally with study sponsors and vendors. The Director of Clinical Operation will oversee Metasite study leaders and be responsible for all clinical and operational aspects of each trial including allocating of resources to each project. Furthermore, the Director will be responsible for the financial management of the department, the allocation of financial and human resources to assure that clinical research studies are
executed on time and on budget. This individual represents clinical operations in opportunity assessment teams and is the point of contact for budget/proposal development for budget and solutioning teams.
Duties include but are not limited to:
Project Guidelines and Communication:
- Oversees the proper conduct of clinical studies at Science 37 in accordance with SOPs and GCPs.
- Develops clear and measurable project management plan in conjunction with Science37 executive team members and sponsor representative(s).
- Serves as subject matter expert internally and with externally.
- Establishes and maintains contacts at various management levels regarding clinical operations department or specific projects.
- Oversees clinical projects including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality and GCP.
- Defines and oversees timelines, milestones and scope of work limitations.
- Establishes and oversees project metrics and project report schedules.
- Serves on early opportunity assessment teams representing clinical operations.
- Contributes to continuous process improvement across the departments.
- Identifies bottlenecks and work with Science 37 departments to address issues.
Project Analysis and Management
- Identifies critical project success factors for tracking, analysis and reporting including probability and impact of potential project risks.
- Helps to develop, manage, and oversee adherence to project budget and contracts and assists in the identification and development of scope change documents.
- Oversees and responsible for project status, timelines, and budget expenditures; identifies potential problems and initiates solutions.
- Initiates scope change process.
- Approves project grants, expense reports and financial records (invoicing/units/expenses).
- Supports Metasite Study Leaders in assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget.
- Develops budget and expense review strategy; creates scope definition documents and creates proactive cost containment strategies; regularly reviews budget/expenses; communicates all of these with Metasite Study leaders.
- Ensures contracting processes are completed in accordance with project timelines and cost parameters.
- Ensures compliance of vendors with study protocols, Good Clinical Practices, worldwide regulatory requirements, SOPs and company policies, quality standards and guidelines.
- Serves as subject matter expert in quality audits (from internal functions and external regulatory bodies), as well as in regulatory inspections.
- 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.
- Active member of Clinical Operations Leadership Team
- Accountable for development, oversight and delivery of Clinical Operations personnel training in key areas.
- Mentors and/or assists in coaching/training clinical operations personnel at all levels, including Metasite Study Leaders, Clinical Research Coordinators and/or other study-associated personnel.
- Conducts performance reviews, calibration sessions and feedback discussions. Performs competency assessments across his/her team and implements and monitors development plans with direct reports.
- Determines needed program processes and assists in development of training programs for Clinical Operations personnel.
- Establishes and communicates team performance expectations and guidelines.
- Manages performance of all service providers, delegating appropriate and challenging assignments to encourage growth, development and responsibility.
- Participates in development and review of departmental Standard Operating Procedures (SOPs), guidelines, and intradepartmental procedures and other continuous process improvements programs, as assigned.
- Collaborates with senior members of the organization, and Directors of Business Development in the development and presentation of Science37 capabilities and proposal defenses.
- Bachelor’s degree required. Advanced degree or equivalent clinical operations experience preferred.
- 10+ years of pharmaceutical-sponsored clinical operations experience (or equivalent) and/or clinical research background in a supervisory role.
- Medical and scientific knowledge required.
Skills and Competencies
- Expertise in clinical operations - Demonstrated ability to successfully manage people/projects, think critically, problem solve proactively, and be able to follow-through until delivery.
- Knowledge of field organizational strategies - Proven ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making.
- Expert knowledge of clinical research – Expertise in the drug development process and the critical elements for success in clinical trials, with previous participation in and contribution to these activities. Ability to review and assist in the development of protocols, programs, and assess the risks and requirements of a project.
- 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.
- 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 relationships with sponsor, project team member and internal Science37 study staff and management. 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 ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
- Leadership – Communicates and exhibits leadership behavior consistent with the company-wide keystone focus. Ability to have difficult/crucial conversations. Understands interpersonal and group dynamics and has a range of interpersonal skills and approached with ability to select a best fit-approach.
- 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 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.
- Metasite Study Leaders
- Clinical Research Coordinators (as needed)
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Enjoy daily 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!