This is a fully Remote and Work From Home (WFH) opportunity within the US
Science 37 is accelerating the research and development of breakthrough biomedical treatments by bringing clinical trials to patients' homes. The Science 37 Operating System (OS) enables universal access to patients and providers, leading to faster enrollment, greater retention, and a more representative patient population. To help us achieve our goal, we are seeking a Provider Enablement Manager eager to make an impact within a mission-driven organization.
The Provider Enablement Manager is a member of the Clinical Operations team responsible for completing onboarding and operationalizing the provider network physicians and staff to facilitate patient enrollment to carryout Decentralized Clinical Trials (DCT) as an integral part of the Science 37 Operating System.
The Provider Enablement Manager 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 Provider Enablement Manager 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.
The Provider Enablement Manager is the bridging point of contact supporting GHP Directors and study teams. The primary role of this position is the onboarding of multiple projects with external provider network participants. This individual is accountable for the communication of the project objectives and is responsible for rapid initiation of the decentralized clinical trial to ensure effective and timely enrollment of provider network patients. The Provider Enablement Manager will assist in efforts to improve study progress, issues, and plans for resolution, in the trials in other phases and ongoing in the same physician provider area. The Provider Enablement Manager is the major influencer for efficient studies start-up under their supervision. In this capacity the Provider Enablement Manager will not have line management responsibilities ensuring that the entire focus of the efforts will be on each provider and project underway to create the most expedited schedule.
DUTIES & RESPONSIBILITIES
Duties include but are not limited to:
- Serves as Provider Enablement Manager regionally or globally for project(s) or programs or service line. Lead Provider Enablement team in all activities during start-up phase. Monitor team efficiency, quality and adherence to project timelines, budget, SOPs and WPs
- Develops, with the input of regulatory and contracts, a study specific Provider Enablement plan
- Communicates overall provider activation status to internal teams
- Directs the process for the selection of providers. Attends project meetings with cross functional department leads to provide strategy for identifying potential providers
- Works with sponsors and internal team members to establish regulatory requirements and contracts necessary for start-up
- Provides work instructions to team members in preparation of regulatory submissions, where applicable
- Establishes processes for the collection and initial review of regulatory packets and site contracts for providers
- Facilitates communication with the clinical team during provider start up, closely monitoring to ensure provider activation timelines are met
- Works with leadership team to design, develop, and update Standard Operating Procedures and WP’s for all provider enablement functions
- Maintains and manages provider enablement data tracking entries in database, and reviews for completeness and accuracy
- Reviews and provides feedback to management on provider performance metrics
- Escalates issues and reports progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps
- Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research
- Facilitates process improvement efforts both within the department and in cooperation with other departments
- Enablement Processes, Procedures, Communication:
- Establishes a post PNA kick-off meeting with Provider, GHP Director and Project Manager (optional). Communicates the study plan outlining, execution, and closeout milestones. Sets expectations for study processes and procedures to Provider
- Utilizes the study support plan provided by the Project Manager. Outlines target KPIs, risk assessment, and contingency planning, as available
- Plays a major initial role working with the GHP Director and Project Managers by assisting in screening and selection of vendors in accordance with contractual timelines, sponsor specifications, quality, budget, and GCP
- Develops and monitors study enablement metrics to continuously assess the ongoing enablement study timelines. Proactively recommends process improvements that can be adopted by the Senior Director, GHP and the GHP Directors
- Using the Project Manager’s plan, facilitates or serves to Communicate to Providers the robust recruitment and retention data-driven strategic plan, including risk assessment and contingency planning, at the start of the study and then monitor throughout its duration and to close-down
- Project Enablement and Provider Influencing
- Accountable for PSSV completion, oversight, and delivery of Provider Network “kick off." Completes Provider team training for specific study needs and projects
- Manages the third-party Vendor requirements at time of project initiation. Study by study basis
- Ensures timely data entry, query resolution and prompt resolution of data issues. Provider Network connection to S37
- Coordinates assignment of needed resources for study conduct and completion with functional area leaders
- Interacts with Clinical Research Coordinators (internal and external) and serve to establish shared working processes, as required, on each study
- Enablement tasks may be required to complete. Practice equipment Calibration records, PSSV completion, Regulatory document updates (GCP, Licenses, CV updates)
- Collaborates with internal and external cross-functional team members to develop study enablement improvements after each enablement process completion
- Works with GHP Director to establish and communicate Provider performance expectations and guidelines
- Leads or assists with training during the enablement phase with both internal and external Clinical Research Coordinators
- 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 SOPs, guidelines, intradepartmental procedures, and other continuous process improvements programs, as assigned
QUALIFICATIONS & SKILLS
- Bachelor’s degree required. Advanced degree or equivalent clinical research experience preferred
- 5+ years of in-depth knowledge of pharmaceutical/biotech-sponsored clinical study management experience or equivalent applicable experience
- Medical and scientific knowledge preferred
- Expertise in study management - Demonstrates ability to successfully influence people and involvement in 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 “Sub-investigator”’ relational management and situational responsive decision-making
- High 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
- 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 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, 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 propriety software
- Financial Skills - Manages and tracks multiple study budgets with a good understanding of study financials
- Practices professionalism and integrity in all actions - Demonstrated 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
- 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)
Benefits of Working in Science 37
Our success depends on the knowledge, capabilities, and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At Science 37, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay but also a wide range of variable pay and recognition programs. In addition, our best-in-class employee benefits, supportive policies, and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
The incumbent reports to Senior 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.
Submit your resume to apply!