Clinical Project Manager

Employer
Alto Neuroscience, Inc.
Location
94022, Los Altos
Posted
May 03, 2021
Ref
1779913
Required Education
Bachelors Degree
Position Type
Full time

The Project Manager is responsible for the overall management and coordination of operational activities involved in the planning, conduct and completion of clinical trials including the management of deliverables, adherence to budget, and ongoing risk mitigation. The PM leads cross-functional project teams (clinical monitoring, data management, biostatistics, medical writing, safety, regulatory affairs, and clinical QA) to ensure the project is completed on time, within budget, and with high quality.

 

Essential Duties and Responsibilities

Responsibilities include but are not limited to:

General:

  • Drive the planning, formation and execution of timelines, while identifying and tracking the team's critical path
  • Facilitate the project team kick-off meeting by identifying key stakeholders and resources
  • Execute and control project activities, including scope, schedule, budget and risk associated with each assigned project. Report performance to senior management
  • Establish communication plans for information distribution to team members
  • Manage project/program meetings
  • Conduct project/program reviews at significant milestones or gates to evaluate successes as compared to baseline estimates
  • Integrate understanding of constraints across and within projects and recommend alternatives
  • Identify and track key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)

Clinical:

  • Assist the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents
  • Assist with IND/CTA submission preparation
  • Create and/or oversee the development of plans and execution of those plans related to site monitoring, safety management, data management and biostatistics
  • Identify, evaluate, and select external vendors as needed (central lab, CROs, consultants/contractors).
  • Assist in development of contracts for, and perform ongoing management of, vendors to ensure deliverables and performance adhere to contract
  • Oversee development of CRFs, clinical and safety databases, and shell Tables, Figures and Listings
  • Oversee the identification, selection and proper initiation of sites
  • Oversee development of CRFs, clinical and safety databases, and shell Tables, Figures and Listings
  • Plan, coordinate and conduct investigator meetings
  • Plan, coordinate and conduct Data Safety Monitoring Board (DSMB) meetings
  • With the Medical Monitor, assess trends in data including adverse events and protocol violations, etc.
  • Oversee timely database freeze and database lock. Participate in data review meeting.
  • Maintain the Trial Master File for each project and oversee the archival process
  • Ensure adherence to SOPs, Good Clinical Practice and FDA/ICH regulations

Education and Experience

  • BS in scientific discipline or pharmacy, RN, or BSN degree or equivalent experience
  • Minimum 4-5 years of clinical trial management experience including some experience with all functional areas involved in clinical trials
  • Ability to travel approximately 20-40% travel based on study demands
  • Excellent working knowledge of GCP/ICH Guidelines
  • Effective written communication skills and computer skills are required

 

Specialized Skills

The PM must possess the ability to work closely with all disciplines within a small company, displaying innovative thinking, a strong sense of responsibility and accountability, and integrity.



Please DO NOT email your resume to us as we only accept applications through our website.