Associate Project Manager - Remote

Project Management United States


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 Associate Project Manager (APM) 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.

The Associate Project Manager (APM), Project Planning and Management (PPM) possesses an advanced understanding of study operations, financial management, and project management terminology/methodology, is highly analytical, and demonstrates effective communication skills internally and externally. The APM is responsible for the day-to-day operations and managing the internal cross-functional team. The APM has a shared responsibility with the Project Manager or Project Director for overall delivery of full service projects and may be solely responsible for projects which are limited in size or scope.

ROLE RESPONSIBILITIES:

  • Manages and provides oversight of the cross functional team (including Regulatory, Clinical Operations, Biometrics, and Medical Affairs/Safety) to ensure milestone achievement and overall project delivery. 
  • Exercises judgement within defined standard operating procedures (SOPs) and ICH/GCP best practices and applies these procedure/best practices to the overall management of the clinical trial.
  • Driving accountability and accuracy of data and metrics reflected in Premier Research systems and tools. Evaluates completed metric data to recommend process improvements and mitigation strategies and raises these to the Functional Leads and Oversight Director as necessary. 
  • Drives the quality of project deliverables through addressing the quality issues with the appropriate team members.    
  • Ensuring key stakeholders are informed of key project metrics on an ongoing basis.
  • Acts as the liaison between Premier Research and the customer for their study(ies) to which they are assigned.   
  • Responsible for high touch customer service and acting as the single point of contact for the project team.
  • Applies overall knowledge of the clinical trial lifecycle and scope of work to effectively drive adherence to the study timelines. 
  • Partners with the Global Resourcing team to ensure adequate resourcing is available to meet project deliverables and milestones. 
  • Leads project team meetings, both internal and external, and other meetings as applicable.   
  • Manages the project budget and scope of work in order to realize project profitability. 
  • Develops, maintains, and updates financial tools to track project budgets.  Ensures project tasks codes are appropriately established in time & expense system and communicates proper billing codes to be utilized by the project team.  Coordinates regular meeting with Project Financial Analyst (PFA) to accurately project revenue for assigned study and review overall financial health of the study.  Identifies, tracks, and forecasts out of scope services, and prepares and maintain Change Orders. Accurately forecasts future revenue recognition.
  • Manages the timely approval of pass-through invoice in accordance with the executed Clinical Trial Agreements. Actively alerts PFA when contractual timelines are met to trigger agreed milestone payments.  Maintains oversight of vendor management responsibilities, including tracking and managing supplies, invoices and budget. Maintains awareness of the tracking and forecasting of out of scope services, and Change Order preparation and approval.
  • Drives the identification and management of risks for all aspects of the project (budget, timeline, quality, etc.) through partnering with the functional leads.  Applies mitigation strategies or contingency plans when triggers are detected.
  • Drives accountability of cross-functional team to ensure accurate project documentation is filed within the TMF.  Ensures that the TMF is accurate, complete, and audit ready at all times.  Responsible for the management of SOP deviations and initiates and resolves Corrective and Preventative Action plans (CAPAs), as appropriate.
  • Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training. 
  • Acquires additional information and skills to enhance job performance, maintain an up-to-date knowledge of Premier Research systems, services, policies and procedures
  • Participates in corporate initiatives and actions that ensure the continued success of the company
  • Ensures accurate and up to date personal training record
  • Responsible for training junior staff at the study level

REQUIREMENTS:

  • Bachelor’s degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific, or health-related field with 5-8 years of clinical research experience.  Within the 5-8 years’ experience, 3-5 years of direct project management support experience with CRO
  • Master’s degree, or international equivalent from an accredited institution, preferably in a clinical, biological, scientific or health-related field, with 3-6 years of clinical research experience.  Out of the 3-6 years’ experience, 1-3 years direct project management support experience with CRO
  • Budget/finance experience on a project level
  • Experience in all phases of a clinical study life cycle
  • Highly confident and effective presenter
  • Working    knowledge    of FDA    guidance documents/EU Directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
  • Intermediate knowledge of project management terminology and guidelines
  • Proficient in MS office suite required