Clinical Project Manager

Company Description

Geneos Therapeutics is committed to advancing personalized therapies that empower the body’s immune system to fight against cancer. Using the innovative GT-EPIC Platform, the company aims to identify and target specific tumor neoantigens, enabling the design, manufacturing, and delivery of personalized immunotherapies. At Geneos, patient-centered innovation drives their approach to combating cancer.

Role Description

This is a full-time hybrid role for a Clinical Project Manager based in Philadelphia, PA, with the option to work from home part-time. The Clinical Project Manager will lead and oversee the planning, execution, and delivery of Geneos clinical development programs. The Clinical Project Manager will provide oversight and manage the Contract Research Organization (CRO) and investigative sites, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. The Clinical Project Manager may have in-house responsibilities, such as collection and review of investigator site start up documents, tracking and IRB submissions. 

Qualifications

•       Lead the planning, initiation, execution, and close-out of clinical trials in accordance with ICH-GCP, regulatory requirements, and company standards.

•       Develop and manage project plans, timelines, budgets, and resource allocation.

•       Coordinate cross-functional teams including clinical operations, regulatory affairs, data management, and medical affairs to ensure project milestones are met.

•       Manage relationships with external vendors, CROs, and investigators to ensure quality and compliance.

•       Strong ability to create and manage study budgets

•       Monitor trial progress, identify risks, and implement mitigation strategies proactively.

•       Ensure compliance with all applicable regulatory and ethical standards.

•       Prepare and present detailed project status reports to senior management and stakeholders.

•       Foster a collaborative team environment and mentor junior project staff.

•       Contribute to the development of clinical development strategies and process improvements.

•       Assists team in development of trial tools or documents

•       Participates in the development process – SOPs, process improvement/ changes

•       Present at meetings, as needed

•       Provides training to team members

•       Escalates issues appropriately

•       Identifies scientific misconduct at the site level and escalates appropriately

•       Collects/ reviews essential documents for completeness and submissions

•       Ensures documents are appropriately filed in the trial master file or shared drives

•       Potential for direct line management 

Minimum Requirements

•       Bachelor’s degree or postgraduate qualification in nursing, life sciences, or medical sciences

•       5 years of experience managing clinical trials and study budgets

•       Approximately 3 years oncology experience

•       Ability and willingness to travel approximately 10% of the time

•       Willingness to work from the corporate office 3-5 days per week

Essential Requirements

•       Excellent communication skills, both written and spoken, eye for detail, good organization and administrative skills

•       Ability to motivate others and work collaboratively with sites, CROs and co-workers

•       Strong working knowledge of ICH/GCP and guidelines

•       Good presentation skills

•       Good working knowledge of word, excel, power point and other Office 365 applications

•       Ability to problem solve independently and collaborate with teams

•       Ability to work in a team environment to support a growing company