Sr. Project Manager, Special Ops
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 seeking a razor-sharp Sr. Project Manager eager to make an impact within a mission-driven organization. The Senior Project Manager in Special Operations is responsible for the operational oversight of internal R&D and clinical research studies conducted by the Special Operations department, in support of Science 37 research programs. This individual will have specific skills in developing and writing scientific protocols, in initiating IRB-approved clinical research studies, and in the overall management of projects involving investigators, study participants and Science 37 staff. The Senior Project Manager will have strong working knowledge of all Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), regulatory guidelines, and best practices under which clinical research studies are conducted. The Senior Project Manager should be comfortable working with various stakeholders, including Executive and Management teams, Study Sponsors, third-party Vendors, Clinical Operations staff, and cross-functional department leaders within the Company. The individual will be adept at utilizing and allocating resources, developing and implementing budgets required to meet project goals, and allocating financial resources to ensure that clinical research studies are successfully executed. The candidate should have strong interpersonal skills, and be able to lead teams, and provide mentorship to junior Project Managers and Study Coordinators as necessary.
Project Guidelines and Communication
- Develop clear and measurable project management plans in conjunction with Special Operations leadership and management teams.
- Define timelines, milestones and scope-of-work limitations to project staff.
- Provide oversight of projects including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality and GCP.
- Serve as Science 37 liaison to interface with external representatives (sponsors, vendors, etc.) at various management levels concerning projects and operations.
Project Analysis and Management
- Identify critical project success factors for tracking, analysis and reporting, including probability and impact of potential project risks.
- Manage adherence to project budgets and contracts, and assist in the identification and development of scope change documents.
- Monitor project status, budget expenditures, milestones, and timelines, and implement corrective courses of action when necessary.
- Coordinate assignment of needed resources for project execution and completion with functional area leaders, and ensure appropriate staffing to accomplish project goals within budget.
- Develop budget and expense review strategies, and create scope definition documents to communicate and review with project team.
- Identify out-of-scope work and initiate the scope change process with sponsor representatives.
- Ensure the site contract and budget negotiation process is completed in accordance with project timelines and cost parameters.
- Supervise, mentor, and train Special Operations personnel at all levels, including project managers, study coordinators and/or other study-associated personnel.
- Ensure compliance of direct reports and vendors with study protocols, Good Clinical Practices, worldwide regulatory requirements, SOPs, company policies, and quality standards and guidelines.
- Responsible for development, oversight and delivery of Special Operations procedures, study operations, and workflows.
- Implement necessary program processes, and train and orient team personnel on these procedures.
- Represent Special Operations department in Company leadership meetings, as required.
- Establish and communicate team performance expectations and guidelines.
- Manage performance of all service providers, to ensure successful completion of clinical studies.
- Delegate appropriate assignments to internal team members, to encourage growth, development and responsibility.
- Participate in development and review of departmental Standard Operating Procedures (SOPs), guidelines, and intradepartmental procedures and other continuous process improvements programs, as assigned.
- Conducts performance reviews, calibration sessions and feedback discussions for direct reports.
- Performs competency assessments across his/her team, and implements and monitors development plans with direct
- Mentors and/or assists in coaching and training departmental team
- Bachelor’s degree required; advanced degree preferred or equivalent clinical operations experience.
- 5+ years of pharmaceutical-sponsored clinical operations experience (or equivalent applicable experience), and/or 5+ years clinical research background in a supervisory role.
- Medical and scientific knowledge required.
- Familiarity with medical writing and statistics preferred.
- Strong interpersonal skills - Demonstrated ability to successfully manage people and projects. Natural leader and team player
- Knowledge of field organizational strategies - Demonstrated ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making
- Extensive knowledge of clinical research - Understanding of the drug development process. Knowledgeable about the critical elements for success in clinical trials, and active contributions to these activities. Ability to review protocols, programs, projects, and study designs
- Strong communication and presentation skills - Strong written and verbal communication skills. Ability to establish and maintain positive relationships with Sponsors, Vendors, internal project team members and all other stakeholders. Ability to conduct effective presentations
- Computer skills - Working knowledge of MS Office suite and Google applications. Ability to generate business correspondence, create forms and generate reports as required. Willingness to gain expertise in the use of propriety software
- Professionalism and integrity in all actions - Demonstrated capabilities in fostering concepts of teamwork, cooperation, self-control, and flexibility to achieve goals
- 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).
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!