What are the responsibilities and job description for the Clinical Trial Project Manager position at Bold Consulting?
THE COMPANY
Our client is a precision oncology company dedicated to reprogramming the tumor microenvironment with the express intent of bringing recalcitrant cancers into submission. We recognize that cancer cells create a hostile microenvironment to privilege their own survival at the expense of the host tissue. Our approach is to attack the structural and biochemical underpinnings of the tumor microenvironment to enable host immune cells and therapeutics to reach the tumor.
Our mission is to serve cancer patients who are the most in need of novel therapeutics. Everything we do is guided by caring for and doing the right thing for those patients. The Company's most advanced clinical program is a clinical trial evaluating safety and potential efficacy of PRTH-101 in patients with advanced solid tumors (NCT05753722).
JOB DESCRIPTION
Our client is seeking a dynamic and experienced Clinical Trial Manager / Clinical Project Manager to join our early-stage biotechnology company. The ideal candidate will have experience in managing clinical trials and clinical projects with a solid understanding of regulatory requirements within the biotech or pharmaceutical industry. The individual will lead and oversee clinical trial operations and should be capable of operating effectively across all functions, from pre-IND to early-stage and late-stage trials. This individual will be responsible for ensuring the successful planning, execution, and completion of clinical studies in compliance with GCP, ICH guidelines, and company policies. This role is critical to advancing our innovative pipeline and supporting our mission to provide novel therapeutics for cancer patients in need.
RESPONSIBILITIES
The Clinical Trial Manager / Clinical Project Manager will manage clinical trials and clinical projects, ensuring alignment with business goals, oversee trial progress, and coordinate with CROs and internal teams.
Clinical Trial Management :
Manage multiple aspects of our clinical development program, ensuring alignment with overall business objectives and timelines.
Oversee the progress of clinical trials from early-stage through late-stage.
Develop and maintain detailed project plans, including timelines, milestones, and resource allocation.
Facilitate meetings with internal teams, external partners, and Contract Research Organizations (CROs) to track progress, resolve issues, and ensure successful project execution.
Operational Management :
Manage relationships with CROs, ensuring high-quality performance and adherence to project timelines and budgets.
Oversee operational aspects of clinical activities and clinical trial activities, including CRO selection and clinical study management, site selection, patient recruitment, and data management.
Ensure site readiness and monitor site performance throughout the trial.
Coordinate with cross-functional teams to integrate non-clinical, clinical, regulatory, data management and quality activities across all stages of development.
Prepare and review study-related documents, including protocols, informed consent forms, and study reports.
Prepare project updates and dashboards, articulating project progress and challenges.
REQUIREMENTS & QUALIFICATIONS
The role of Clinical Trial Manager / Clinical Project Manager requires a unique blend of clinical trial and project management expertise and a deep understanding of the drug development process. The ideal candidate will have a strong background in biotech or pharmaceuticals, with proven skills in managing complex trials, projects and cross-functional teams.
QUALIFICATIONS
Bachelor's degree in Life Sciences, or a related field; advanced degree preferred.
Minimum of 6 years of project management experience in the biotech or pharmaceutical industry, with a proven track record in managing clinical and non-clinical projects.
Strong understanding of clinical trial processes, regulatory requirements, and CRO management.
Excellent organizational, leadership, and communication skills.
Ability to work collaboratively in a fast-paced, dynamic environment.
Proficiency in project management tools and software.
Demonstrated ability to manage multiple projects simultaneously and to adapt to changing priorities.
BENEFITS
Competitive salary and benefits package.
Opportunity for professional development and career advancement.
A supportive and innovative work environment.
Access to cutting-edge technology and research tools.
