Clinical Project Manager II

CATO SMS is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. CATO SMS is a non-laboratory environment.

We are currently recruiting for a Project Manager II to join our team in North America. The Project Manager II (PM II) is responsible for the overall coordination and management of clinical trials from start up through to final delivery. This position directs the technical and operational aspects of clinical projects - all with the sense of urgency expected of CATO SMS customers.

Location: North America

Responsibilities:

• Leads the project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract
• Creates and executes project management plans required for project delivery and in accordance with established processes
• Ensures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines.
• Establishes clear communication lines and escalation pathways, communicates with project stakeholders
• Provides input on study related documents such as the study protocol, CRF, Medical Review/Monitoring plan, and Clinical Study progress Report
• Establishes requirements for and ensures project specific training plan for team activities
• Leads internal and external meetings, with internal and sponsor teams, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope
• Provides support for vendor identification, qualification and selection and manage vendors
• Manages vendors and vendor relationships as required for project delivery
• Ensures effective and efficient resource utilization across projects and programs
• Produces, maintains and circulates project progress and status reports
• Manages the study budget, including monthly invoicing.
• Establishes project risk management plan with input from client and functional stakeholders and oversees adherence and updates throughout the project lifecycle
• Proactively recognizes and addresses any changes in scope
• Negotiates and influences internal and external team members in a professional manner and with successful outcomes
• Conducts review of initiation, monitoring and close-out visit reports
• May perform co-monitoring visits
• Ensures the Trial Master File is kept up to date and audit ready.
• Contributes to other areas of business as required

Client management:

• Serves as the primary point of communication between the sponsor and project team

Leadership:

• Leads by example and encourages team members to develop strong solutions for clinical trial delivery
• Responsible for oversight of project team delivery and communication with functional managers, including performance feedback

Requirements

Qualifications:

• Minimum Bachelor’s degree in life science, healthcare and/or business degree
• Minimum 5 years of relevant work experience
• Minimum 3 years of experience in drug development and/or clinical research
• Preference for candidates with CRA experience
• Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
• Demonstrates financial acumen, administrative excellence and sound analytical skills

Skills:

• Strong written and verbal communication skills, including command of the English language
• Ability to work in a fast-paced challenging environment of a growing company
• Outgoing and client focused
• Strong general administrative skills and experience
• Proficiency with various applications including but not limited to Microsoft Word, Excel, and PowerPoint required
• Good presentation skills
• Fosters learning and the advancement and development of others
• Demonstrates an ability to maintain effectiveness in a changing environment
• Dependable and able to take action quickly to address urgent needs
• Proactive and solution oriented
• Willingly takes ownership and drives positive results with the project team
• Exercises good judgement with defined procedures and policies to determine appropriate action
• Ability to work in a fast-paced challenging environment with a growing company