Project Manager

Job Description

Job Summary:

• This role is a member of the Clinical Trial Accelerator Unit (CTAU) taking broad responsibility for accelerating Study Start Up activities, harmonizing processes and providing start-up expertise to studies and programs to which they are assigned, to ensure study teams meet and exceed the Final Protocol to First Patient In timelines and ensure all sites in the study are activated on time.
• This role is predominantly an oversight role and works in close collaboration with the Clinical Trial Lead (CTL) who has overall accountability for the study.

Responsibilities:

• The Study Start Up Project Manager (SSU PM) is responsible for ensuring that Study Start Up and site activation deliverables are achieved in a timely and efficient manner, compliant with client SOPs and procedural documents, applicable local regulations and international guidelines such as ICH and GCP.
• Tasks vary from study to study but include building out a MS Project plan for all activities and holding the team accountable for task driven progress, maintaining the Quantitative Science and Development Operations (QSDO) study dashboard, as well as closely monitoring individual site activations.
• Feasibility, Site Selection, Site contracting and budgets, Vendor set-up, Informed Consent management, and overall site engagement.
• The SSU PM may support special projects, develop templates, materials and processes or perform other assigned tasks as needed.
• The SSU PM would be expected to be proficient in MS Project.

Educations and Skills Required:

• B.A. or B.S. in a scientific discipline; advanced degree preferred.
• Scientifically and clinically astute with very strong project management skills.
• Good knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
• Proficiency in MS Project.
• Advance use of MS Excel.
• Previous use of Veeva CTMS and Study Start Up module would be ideal.
• At least 5 years of clinical research experience of which at least 3 years of Study Start Up management experience with a sponsor company managing outsourced clinical trials within quality, timeline, and budget expectations.
• Prior CRO or investigator site and/or monitoring experience is a plus.
• Good organizational and time management skills.
• Good communication and interpersonal skills.
• Good negotiation skills.
• Ability to work in a matrix environment.