Clinical Project Manager I

POSITION OVERVIEW 

The Clinical Project 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 Clinical Project 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 Clinical Project 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 Harmonization (ICH) guidelines and other applicable federal (FDA) and state  regulations, to achieve established goals within timelines and budget.  

The Clinical Project 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 Clinical Project 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: 

1. Project Guidelines and Communication: 
   1. Develops study plan outlining planning, execution, and closeout milestones 
   2. Develops a study management plan in conjunction with the Director, Clinical Operations, and sponsor  representative(s) outlining target KPIs, risk assessment, and contingency planning 
   3. Leads multi-disciplinary Study Management Team 
   4. 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. 
   5. Assists in screening, selection, and management vendors in accordance with contractual timelines,  sponsor specifications, quality, budget, and GCP 
   6. Develops and monitors study metrics to continuously assess study progress 
   7. Acts as the primary point of contact between Science 37 and sponsor project team 
   8. In collaboration with the study management team, and Marketing, develops a robust recruitment and  retention data-driven strategic plan including risk assessment and contingency planning, at the start of  the study and monitors throughout its duration and to close-down.  
2. Project Analysis and Management 
   1. Identifies critical project success factors for tracking, analysis and reporting including impact and  probability of project risks 
   2. Monitors and tracks study status, timelines, and budget expenditures; identifies opportunities and  recommends implementation plan for efficiency measures 
   3. Accountable for overall study budget, ensuring that all invoices are paid, issues are addressed, and  revenues are booked in timely manner. 
   4. Ensures timely data entry, query resolution and prompt resolution of data issues
   5. Coordinates assignment of needed resources for study conduct and completion with functional area  leaders; ensures appropriate staffing to accomplish project goals within budget
   6. Identifies out-of-scope work and reports the scope change process to leadership
   7. Responsible for review of study budget, expense reports and financial records (invoicing/units/expenses)  in conjunction with appropriate project team members
   8. 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
   9. Ability to analyze data and information to derive conclusions and drive critical decision-making 
3. Leadership 
   1. Accountable for development, oversight and delivery of team training for specific projects 2. 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 protocols, ICFs, manuals,  presentation decks, risk plans, etc. 
   2. Determines needed project processes and trains study teams; maintains study team knowledge and  application of project processes 
   3. Establishes and communicates team performance expectations and guidelines 
   4. Manages performance of external service providers as required 
   5. Provides performance evaluation input for Science 37 project team members and service providers 7.
   6. Participates in development and review of departmental SOPs, guidelines, intradepartmental procedures,  and other continuous process improvements programs, as assigned 
4. Business Development 
   1. Supports the development of project proposals by participating as Subject Matter Expert (SME) in internal  and external meetings. Represents Science 37 in sponsor and vendor relationships as required. 2. Understands customer needs and appropriately influences decision-making. 

QUALIFICATIONS & SKILLS 

Qualifications  

The following qualifications are preferred/or equivalent applicable experience: 

1. Bachelor’s degree or equivalent applicable experience required. Advanced degree or equivalent clinical  research experience preferred. 
2. Minimum of 2 years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience required
3. Medical and scientific knowledge preferred 

Skills/Competencies 

1. Expertise in study management - Demonstrates ability to successfully manage people and multiple clinical  studies. Proactive problem-solving abilities and follow-through. 
2. 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. 
3. 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. 
4. 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. 
5. 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. 
6. Strong motivational and influence skills – Ability to motivate, influence and guide team members; gains  commitments from others 
7. 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. 
8. 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.  
9. Financial Skills - Manages and tracks multiple study budgets with a good understanding of study financials 10. Practices professionalism and integrity in all actions - Demonstrates commitment to teamwork,  cooperation, self-control, and flexibility in all areas of work. 
10. Leadership – Communicates and exhibits leadership behavior consistent with the company-wide keystone  focus. Ability to have difficult/crucial conversations.  

Capabilities  

1. Ability to travel up to 20%, as needed, for project team meetings, client presentations and other  professional meetings/conferences 
2. Ability to communicate in English (both verbal and written) 

REPORTING 

The incumbent reports to Director, Clinical Operations, who will assign projects and provide general direction and  guidance. Incumbent is expected to perform duties and responsibilities with minimal supervision. 

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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