Senior Clinical Project Manager
Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients’ homes. By leveraging the latest innovations in mobile technology, cloud services, telemedicine, and mass-engagement channels like Facebook and Google, we are breaking down traditional geographic barriers to patient trial participation while shortening the time needed to bring new treatments to market.
We value employee well-being and aim 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.
The Senior Project Manager fulfills the requirements of managing clinical trials (related to Diabetes, Psychiatry and Neurology) to ensure timely delivery of required project objectives and timelines within the scope of the client agreements for assigned projects and the project budget. In doing so, the Senior Project Manager 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 Senior Project Manager is responsible for the execution of clinical trials from end-to-end and may be the principal liaison with the client to ensure effective and timely communication of project progress, issues and plans for resolution of those issues.
Duties include but are not limited to:
Project Guidelines and Communication:
- Assists in developing clear and measurable project management plan in conjunction with the Vice President of Strategic Operations, Director of Clinical Operations, and sponsor representative(s).
- Management (within the country or regional geography) of clinical projects including deliverables from all functional areas and vendors in accordance with contractual timelines, sponsor specifications, quality and GCP.
- Adheres to defined timelines, milestones and scope of work limitations; communicates it to project staff.
- Adheres to established and defined project metrics and project report schedules with client representatives. Provides at least monthly project updates.
- May act as the primary liaison between the project team and the sponsor/customers and service providers.
Project Analysis and Management
- Assists in identifying critical project success factors for tracking, analysis and reporting including probability and impact of potential project risks; reports it to leadership.
- Monitors project status, timelines, and budget expenditures; identifies problems and recommends solutions.
- Coordinates assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget.
- Identifies out-of-scope work and reports the scope change process to leadership.
- Responsible for review of project grants, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members.
- 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.
- Establishes and communicates team performance expectations and guidelines.
- Mentors and/or assists in coaching/training junior project managers and clinical research coordinators.
- Conducts performance reviews, calibration sessions and feedback discussions. Performs competency assessments across his/her team, and implements and monitors development plans with direct reports.
- Manages performance of external service providers as required.
- Provides performance evaluation input for Science37 project team members and service providers.
- Participates in development and review of departmental Standard Operating Procedures (SOPs), guidelines, intradepartmental procedures, and other continuous process improvements programs, as assigned.
- Supports the development of project proposals by participating as requested. Represents 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.
- Experience in the following therapeutic areas preferred/a plus: Diabetes, Neurology and Psychiatry.
- Expertise in project management – Demonstrated ability to successfully manage people/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 proprietary software.
- Practices professionalism and integrity in all actions – Demonstrated commitment to teamwork, cooperation, self-control, and flexibility in all areas of work.