Project Specialist / Sr. Project Specialist
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as Analgesia, CNS, Rare Diseases, Dermatology, Oncology, and Pediatric research.
We’re looking for a talented and energetic Project Specialist / Senior Project Specialist to join our team! This is an excellent and exciting opportunity to develop Project Management skills, and successfully grow within Project Management.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
As a Project Specialist / Senior Project Specialist for Premier Research, you’ll have the opportunity to collect and analyze data from various sources including systems, tools, and communication with functional leads to provide comprehensive updates, trend analysis, and conclusions to the Project Manager which is critical to ensure high quality, on budget, on time, delivery of the project according to the scope of work and within accordance with ICH, GCP, and Standard Operating Procedures (SOPs). For this role, you’ll need to possess an advanced understanding of study operations, financial management, and project management terminology/methodology, is highly analytical, and demonstrates effective communication skills internally and externally.
What you’ll be doing:
- Overall Project Delivery: direct overall Project Delivery through management and coordination of efforts assigned to entire project team, (including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety). This includes collecting and analyzing data from operational study leaders in order to develop, maintain, and update Premier Research Key Performance tools; evaluating completed metric data to recommend process improvements and mitigation strategies to the Project Manager; assist in identifying resources needed for assigned studies per the respective Scope of Work (SOW); managing the initial start-up activities including setting up project systems, SOP indexes, and study team lists.
- Study Deliverable Tracking: Collect information as it pertains to functional department deliverables and milestones through clear communication with the functional leads and use of various study databases. Identifies when study metrics are at risk.
- Communications: initiate team communications and documentation internally and externally. Act as backup in the absence of a Project Manager to address internal team member issues and to be the main point of contact for the customer. Maintain internal and external project team contact list. Provide competent support for efficient project team meetings, both internal and external, including scheduling and leading; preparation and distribution of meeting minutes; and maintenance of action item logs including managing direct follow-up on action items to ensure appropriate resolution.
- Timeline Management: lead in ensuring project delivery is within all contracted timelines.
- Financial Management: lead in in ensuring adherence to project budget and scope of work in order to realize project profitability. This includes:
- Ensuring project tasks codes are appropriately established and communicating proper billcodes to be utilized by the project team.
- Coordinating regular meeting with Project Financial Analyst (PFA) to accurately project revenue for assigned study per the revenue workbook and review overall financial health of the study. Managing the timely approval and tracking of pass-through invoice in accordance with the executed Clinical Trial Agreements. Actively alerting PFA when contractual timelines are met to trigger agreed milestone payments; coordinating vendor management, including tracking and managing supplies, invoices and budget; identifying, tracking, and forecasting out-of-scope services, and preparing and maintaining Change Orders. Accurately forecasting future revenue recognition.
- Risk Management: Manage risks for all aspects of the project (budget, timeline, quality, etc.) by identifying potential risks, their triggers, proposing mitigation strategies to the PM, and ensuring the risk is avoided or mitigated.
- Audit Readiness and Trial Master File: ensure all assigned projects are audit ready; i.e., project tasks are completed in accordance with project plans and SOPs and are filed to TMF; initiate TMF development and ensure the TMF is accurate, complete, and audit ready as all times.
You’ll need this to be considered:
- Undergraduate degree in a clinical, biological, scientific, or health-related field and 3 years relevant clinical research experience, including Project management support experience within CRO or pharmaceutical / biotech industries
- Strong understanding of the drug/device development process, the lifecycle of a clinical trial, and has a basic understanding of the functional groups assigned to clinical trials; Proven experience to manage project finances by participating in revenue recognition, revenue projections, completing investigator/vendor payments, and generating invoices for sponsors
- Working knowledge and understanding of document control, project management terminology, ICH/GCP, and FDA Guidance Documents
- Strong computer skills in MS Office required, including Excel, Power Point, Outlook and MS Project
- Strong planning, tracking and time-management skills with the ability to act proactively to coordinate multiple tasks to meet deadlines while focusing on quality standards; strong ability to analyze data and trends as well as potential risks
- Accountable, dependable and strong commitment; ability to act independently to support the study team during team member absences, transitions, and overall
- Is customer service focused in approach to work, both internally and externally with strong verbal and written communication skills; approaches challenges creatively
- Maintains a positive, results orientated work environment