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, medical device and diagnostics, and pediatric research.
We’re looking for a talented and energetic Project Specialist to join our team!
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!
The Project Specialist (PS) possesses a basic understanding of study operations, project management terminology, is analytical, and demonstrates effective communication skills.
This role collects and analyzes data from various sources including systems, tools, and communication with functional leads to provide comprehensive updates, trend analysis, and conclusions to the Project Manager (PM) to assist in ensuring 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).
As a PS you'll be accountable for:
- Assisting in overall Project Delivery through coordination of efforts assigned to entire project team, (including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety). Facilitates overall study team tracking, timeline adherence, finance accountability, team communication, and study documentation (TMF) as appropriate.
- Collecting information as it pertains to functional department deliverables and milestones through clear communication with the functional leads and use of various study databases. Assists in the identification of risks to the milestones and deliverables.
- Initiating team communications and documentation internally and externally. Maintaining internal and external project team contact list.
- Ensuring project delivery is within all contracted timelines.
- Adhering to project budget and scope of work in order to realize project profitability.
- Ensuring assigned projects are audit ready; i.e., project tasks are completed in accordance with project plans and SOPs and are filed to TMF, as appropriate.
As a PS you'll need this background to be considered:
- Undergraduate degree in a clinical, biological, scientific, or health-related field and 1-2 years relevant clinical research experience or equivalent combination of education, training and experience
- Project management support experience within CRO or pharmaceutical industry preferred
- Familiarity with ICH/GCP regulations
- Working knowledge of FDA Guidance Documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
- Basic knowledge of project management terminology and guidelines
- Strong computer skills in MS Office required