Senior Clinical Project Manager

3 weeks ago

Seattle, United States BrainChild Bio Full time

The Senior Clinical Project Manager role at Brainchild Bio will lead the comprehensive execution of clinical trials, overseeing both scientific and operational aspects. In addition, this role will prioritize patient safety and data integrity while ensuring strict compliance with regulatory guidelines, company protocols, and timelines. As Brainchild Bio seek to improve in all aspects of clinical development, this role will actively contribute to building and refining operational processes for continual improvement.


Key Responsibilities:

  • Planning: Develop study plan(s) including key milestones, budget, and timelines for clinical trials in line with company goals.   
  • Oversight: Oversee performance of the cross-functional clinical team (which may include internal resources, CROs, third party vendors, and contractors) to ensure effective and compliant execution of the study protocol, identifying and escalating issues to leadership when appropriate.  
  • Execution:  Coordinate and direct execution of clinical trial activities from site initiation, subject recruitment, through database lock and study close-out, for example: 
  • Serve as the primary point of contact for trial specific issues and deliverables.  
  • Manage critical study documents, such as Protocol, Investigator’s Brochure, Informed Consent, operational plans, subject recruitment materials.  
  • Participate in the development and testing of clinical systems (e.g., electronic data capture). 
  • Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting.  
  • Ensure internal and external systems are updated in a timely manner (e.g., metrics tracking, clinicaltrials.gov). 
  • Collaborate with applicable functions (at CRO or internally) to ensure robust plans for routine monitoring and study level data review, including trend evaluation, are in plan and followed.   
  • Develop and utilize tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points. 
  • Communicate trial status, issues, and mitigations to stakeholders. 
  • Ensure subject safety and welfare, data integrity, and trial compliance at all times.  
  • Infrastructure Development:  Support the build of BrainChild Bio’s clinical infrastructure including development of relevant Policies, Standard Operating Procedures, templates, and tools.  
  • Maintain and share up-to-date knowledge of relevant industry guidelines and regulations.


Key Behaviours and Skills:

  • Effective Communication: Ability to translate complex issues into plain language. Must be able to be an effective storyteller and able to bridge gaps, lead change, and influence others.  
  • Positive Leadership & Collaboration: Comfortable leading teams and peer’s through challenges. Must be a team player and open to learning new techniques and growing your skillset from others. 
  • Organization: Systematic organization, coordination, and ability to focus on detail are essential to ensure clinical trials are conducted in accordance with the highest Good Clinical Practice standards and requirements.   
  • Problem Solving: Ability to critically assess complex technical and/or interpersonal situations, recommend and implement solutions.   
  • Agility: Ability to effectively multi-task, manage time, and adapt in a fast-paced and evolving, highly regulated environment. 


Qualifications:

  • Bachelor’s degree in a scientific discipline is required
  • Minimum of 8 years of clinical development experience in the biotech/pharmaceutical industry
  • Expert knowledge of Good Clinical Practice (GCP), Code of Federal Regulations (CFR), and International Council for Harmonisation (ICH) 
  • Experience with project management tools related to forecasting and tracking cost, schedule, and performance  
  • Experience with all aspects of trial and site startup and vendor management
  • Experience in rare disease, pediatric, and/or complex clinical trials preferred
  • Ability to deal with multiple priorities with aggressive timelines
  • Strong oral and written communication skills
  • Ability to find creative solutions to issues impacting timelines and budgets


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