CATO SMS and Pharm-Olam, LLC have merged to form Allucent!

Allucent 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. Allucent is a non-laboratory environment.

We are currently recruiting for a Senior Project Manager to join our team in the Canada with the option to work remotely. The Senior Project Manager (Sr. PM) 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 Allucent customers. Candidate must have oncology experience; preference for early phase oncology, along with immune-oncology and/or cell therapy.

Location: US and Canada (remote)

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 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
Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills
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 inspection ready

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
May be assigned as line manager

Equal Employment Opportunity and Affirmative Action

Cato Research LLC is committed to Equal Employment Opportunity and Affirmative Action. We recruit, hire, train and promote qualified persons in all job titles and ensure that all other personnel actions are administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, marital status, military and/or veteran status, or disability. Furthermore, to the extent required by applicable laws and/or Executive Orders, we take affirmative action to ensure that minority group individuals, females, disabled veterans, recently separated veterans, other protected veterans, Armed Forces service medal veterans, and qualified disabled persons are introduced into our workforce and considered for promotional opportunities. Cato Research, LLC is committed to providing reasonable accommodations to employees and applicants with disabilities to the full extent required by the Americans with Disabilities Act - ADA. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 919.361.2286.

Requirements

Qualifications:

Minimum Bachelor’s degree in life science, healthcare and/or business degree
Minimum 5-7 years of relevant work experience
Minimum 5-7 years of experience in drug development and/or clinical research, with at least 5 years of clinical trial project management experience
Preference for candidates with CRA experience
Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
Demonstrates strong financial acumen, administrative excellence and analytical skills
Experience managing all phases of the full-service clinical trial delivery lifecycle (Start-up, Maintenance, Close-out).

Skills:

Excellent written and verbal communication, planning, critical thinking and organizational skills, including command of English language
Representative, outgoing and client focused
Ability to work effectively in a fast-paced challenging environment with a growing company
Proficiency with various applications including, but not limited to, Microsoft Word, Excel, and PowerPoint required
Strong presentation skills
Fosters learning and the advancement and development of others
Dependable and able to take action to quickly to address urgent needs
Proactive and solution oriented
Willingly takes ownership and drives positive, collaborative results with the project team
Exercises good judgement with defined procedures and policies to determine appropriate action

To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes

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