1. Project Specialist \/ Senior Project Specialist
P

Project Specialist \/ Senior Project Specialist

Premier Research

Project Specialist \/ Senior Project Specialist

Premier Research

  • Warszawa, mazowieckie
  • Stała
  • Pełny etat
  • 5 dni temu

Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We're looking for an exceptional Project Specialist / Senior Project Specialist to join our team in Warsaw, Poland and to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.

At Premier Research, we are science-minded and heart-centered. Join us.

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.

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 Sr. PS you'll be accountable for:
  • Directing overall Project Delivery through management and coordination of efforts assigned to entire project team (including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety). Facilitating 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. Identifying risks to the milestones and deliverables.
  • Initiating team communications and documentation internally and externally. May be identified as the 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. Maintaining internal and external project team contact list.
  • Take the lead in ensuring project delivery is within all contracted timelines.
  • Take the lead in ensuring adherence to project budget and scope of work in order to realize project profitability.
  • Managing 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.
  • 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.
Requirements:
  • For Project Specialist: 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
  • For Sr. Project Specialist: Undergraduate degree in a clinical, biological, scientific, or health-related field and 3+ years relevant clinical research experience or equivalent combination of education, training and 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/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
  • 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

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