About the Job
Diligent Pharma is a technology growth-company serving an international marketplace in the critical Pharmaceutical/Biotech sector. Diligent operates a Software-as-a-Service platform which enables Sponsors and implementors of clinical trials to rapidly identify, evaluate and qualify clinical service providers. Our ability to leverage vendor qualification information across multiple sponsors brings efficiency to the quality/risk management process for all parties and significantly speeds the delivery of capability assessments. We have launched and proven a new model for vendor qualification that is transforming the industry’s de facto wasteful approach.
The Director of Provider Qualification Services is responsible for managing the engagement of Providers and the associated completion of Auditor led Vendor Qualification Assessments (VQA’s) and in-study Vendor Audits (VA). This role works closely with the other members of the Operations team including the Director of Provider Services to provide excellent proactive customer service for the Provider side of the Diligent Qualification Platform (DQP). The day-to-day job responsibilities include, but are not limited to:
- New Provider On-Boarding
- Introduce the Diligent Business Model and the DQP to Providers to ultimately influence the Providers to sign the Provider Agreement and joint the DQP. This is in partnership with the Director of Provider Services.
- Establish On-Boarding/Training Meetings with newly contracted Client/Providers in partnership with the Director of Provider Services.
- Establish clear understanding of the DQP business process and model with new Client/Providers. Shape Client/Provider expectations to follow DQP processes.
- Provider Qualification Management
- Establish shared Teams folders to store key documents related to our engagement with the Provider are created and maintained with key documents.
- Facilitate Auditor Selection by reviewing Auditor CV’s to ensure appropriate background to evaluate the services for each requested Provider VQA.
- Facilitate VQA and VA Report editing with Internal and Sponsor Feedback and ultimately ensure VQA and VA Reports are finalized with Provider Corrective Action & Preventive Action (CAPA) commitments.
- Process Approved VQA Reports by uploading to Teams folder and ensure they are Anonymized for Upload to the DQP.
- Request CAPA updates from Providers once requests for access to Existing VQA Reports are received from Client/Sponsors.
- Track and Monitor performance metrics for each VQA and VA processes to optimize cycle times and lead continuous improvement efforts.
- Define Provider Engagement periodic touchpoints to strengthen long term relationships.
- Provider Agreement Process Management
- Ensure the terms of the Provider Agreement (PA) are well understood by the Providers and work to optimize the contract language over time based on Provider feedback.
- Develop PA status reporting that provides on-going status of Provider Agreement.
- Optimize and simplify the process for obtaining Provider Agreement approval and improve the PA acceptance rate.
- Provider Request Management
- Establish Provider rapport to proactively encourage timely completion of Diligent Requests.
- Provide oversight over Provider requests with internal Diligent Operations team members and expedite requests as necessary.
- Track delivery of RFI requests from Provider to Client/Sponsors through to closure and ensure proper documentation and metrics are completed
- Provider Metrics & Dashboard
- Develop Provider Metrics Strategy for Diligent Operations with input from select Providers and internal Diligent Operations Team.
- Define Performance Metrics and data collection plan with roadmap for future metrics automation on the DQP
- Develop and report on Provider metrics to Operations Team and Lead Team.
- Review metrics to ensure work is managed to meet Providers & Sponsors expectations and identify process improvement opportunities
- Provide Strategic and Operational Input into DQP Development Roadmap
- Provide continuous feedback to Head of Product Development on DQP feature improvement ideas.
- Participate in DQP Strategy discussions to refine our Roadmap and Vision for our product offering
- Bring forward proposals to the Diligent Lead Team on opportunities to strengthen the DQP, our Business Model and ultimately our Profitability.
- Lead Process Improvement Projects
- Provide leadership to establish scope for select improvement projects
- Gain Diligent Lead Team (DLT) support for improvement projects
- Assemble project team with appropriate SME’s
- Evaluate and propose improvement solutions to the DLT
- Develop implementation plan for approved solutions
- Marketing & Sales Support
- Participate in select Sales calls with potential customers to represent the Diligent Operations Team
- Provide subject matter expertise on our services to potential customers
- Answer technical questions regarding the DQP and our operational processes
- Provide External Engagement to Market the Diligent Solution to potential future customers via Webinars, Conference Presentations, Prospective Client Presentations, etc...
- Customer Support for Providers
- Document Provider DQP Issues and identify trends that should influence future DQP enhancements.
- Ensure Provider Users on DQP functionality are retrained (if necessary)
- Serve as backup to other Diligent Operations Team roles when required due to absences, vacations, extended leaves or vacancies.
- Other duties as assigned.
Skills & Experience Required
- Bachelor’s Degree
- At least 10 Years of progressive experience in Pharma/Biotech Clinical Research or vendor support of Clinical Research
- Experience in leading complex Process Improvement Projects
- Understanding of Vendor Qualification process and regulatory requirements
- Strong interpersonal & relationship management skills
- Strong problem solving & analytical skills with high attention to detail
- Strong written & verbal communication skills
- Strong capability utilizing Microsoft Word, Excel and PowerPoint
This role is full-time and remote. Our offices are headquartered in Philadelphia, PA. We offer competitive salaries and benefits in a flexible virtual work environment.