POSITION OVERVIEW
The Site Operations Manager I is a member of the Clinical Operations department accountable for on-time and on-budget delivery of clinical studies using the highest quality standards.
The Site Operations Manager I will have a broad therapeutic knowledge leading the multifunctional study management team within a matrix environment. The study management team is collectively responsible for planning, solutioning, recruiting, executing, and close-out of clinical studies, within the scope of the client agreement. In doing so, the Site Operations Manager I will oversee all operational aspects of clinical trials according to and in 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, to achieve established goals within timelines and budget.
The Site Operations Manager I is the single point of contact to client study teams working with internal and external stakeholders. This individual is accountable for the delivery of the project objectives on-time and on-budget and is responsible for end-to-end execution of clinical trials to ensure effective and timely internal and external communication of study progress, issues, and plans for resolution. The Site Operations Manager I is also responsible for efficient resourcing and financial management of studies under their supervision.
DUTIES AND RESPONSIBILITIES
Duties include but are not limited to:
Project Guidelines and Communication:
- Develops a project management plan in conjunction with the appropriate cross-functional teams, outlining planning, execution, and closeout milestones in addition to communication and contingency plans
- Leads 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. Ability to identify and organize resources and services needed to accomplish tasks, sets objectives, plans for contingencies, and manages time effectively.
- Develops and monitors study metrics to continuously assess study progress
- Acts as the primary point of contact between Science 37 and sponsor project team, and independently leads internal and external project team meetings
Project Analysis and Management
- Identifies critical project success factors for tracking, analysis and reporting including impact and probability of project risks
- Monitors and tracks study status, timelines, and budget expenditures; identifies opportunities and recommends implementation plan for efficiency measures
- Ensures timely data entry, query resolution and prompt resolution of data issues
- Coordinates assignment of needed resources for study 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
- Assists with the development of a budget/ contract change order as appropriate in conjunction with the Director, Clinical Operations, and the business development teams.
- Responsible for review of study budget, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate project team members
- Ensures 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
- Assists and supports study audit preparations
Leadership
- Accountable for development, oversight and delivery of team training for specific projects
- Applies expertise in day-to-day Clinical Operations activities, collaborates with internal and external cross-functional team members to develop study documents and manuals, including ICFs, manuals, presentation decks, risk plans, etc.
- Determines needed project processes and trains study teams; maintains study team knowledge and application of project processes
- Establishes and communicates team performance expectations and guidelines
- Manages performance of external service providers as required
- Provides performance evaluation input for Science 37 project team members and service providers
Business Development
- Understands customer needs and appropriately influences decision-making.
QUALIFICATIONS & SKILLS
Qualifications
- 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
Skills/Competencies
- Knowledge in study management - Demonstrates ability to successfully manage 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. 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. Confidently interacts with key internal and external stakeholders including department heads, senior management, PIs, vendors and consultants. Has a range of interpersonal skills, handles constructive criticism and learns from it, and approaches with the ability to select a best-fit approach. Has a good understanding of other company functions and their inter-relationship to achieve project deliverables.
- Strong motivational and influence skills – Ability to motivate, influence and guide team members; gains commitments from others
- Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, study 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.
- Financial Skills - Manages and tracks multiple study budgets with a good understanding of study financials
- Practices professionalism and integrity in all actions - Demonstrates 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.
Capabilities
- Ability to travel up to 20%, as needed, for project team meetings, client presentations and other professional meetings/conferences
- Ability to communicate in English (both verbal and written)
Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed.
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