Clinical Trials Program Manager
6 days ago
About Us
Immix Biopharma (Nasdaq: IMMX), a clinical-stage biopharmaceutical company, is revolutionizing cell therapies in oncology and autoimmune diseases. Our lead asset, NXC-201, aims to be the world's first single-day CAR-T, enhancing patient care and paving the way for expansion into autoimmune indications.
We're a team of dedicated professionals working together to develop life-changing therapies. We hire exceptional individuals and empower them to do inspired work.
Our Core Values
- Intelligence
- Integrity
- Initiative
Your Role in Advancing Clinical Trials
Job Summary:
The Clinical Trials Program Manager oversees the ownership, accountability, and results of clinical trials. They provide project management to plan, prepare, and execute one or more clinical studies from initiation to close out.
Key Responsibilities:
- Implement, manage, and terminate clinical studies in accordance with protocols, Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and other regulatory requirements.
- Develop detailed plans, prioritize tasks, coordinate, and provide oversight of all elements of the clinical trial(s) to attain project deliverables and achieve project goals within specified timelines and budget.
- Communicate the status and progress of clinical trial(s) and raise issues related to study conduct, including timelines, enrollment, and/or budget, with study team members, functional teams, and management.
- Develop and implement appropriate actions to address issues with clinical trial(s).
- Provide oversight of project team members and deliverables and ensure all necessary project-specific training is provided.
- Lead efforts to ensure on-time development and distribution of study-specific documents, including study protocols, data management plans, statistical analysis plans, informed consent documents, case report forms, monitoring plans, study manuals, training plans and materials, and other study tools and plans.
- Demonstrate thorough knowledge of and supervise others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.
- Participate in the development and implementation of internal policies & procedures to optimize management of clinical trials; contribute to process improvement.
- Participate in the selection of and management of issues related to study investigators, various clinical study contractors and vendors, including contract research organization (CRO) staff, contract monitors (domestic and international), IRB/ECs, etc.
- Review Monitoring Trip Reports provided by Monitors for all phases of clinical trial(s), including site evaluations, initiations, interim monitoring, and close-out visits.
- Provide mentoring to junior staff and sites regarding protocols and site management.
- Responsible for baseline timeline development and manage the study according to planned budget and timelines.
- Oversee development and collection of site non-disclosures, contracts, and budgets.
- Oversee site evaluations, activations, monitoring, and closures to ensure on-time delivery and act on any deviations from plan.
- Help select and qualify clinical trial investigational sites.
- Prepare, participate in, and coordinate presentation of training materials, including study team member training, investigator meetings, Site Initiation materials, and protocol training materials.
- Lead preparation and execution of study meetings (e.g., kick-off meetings, investigator meetings, periodic study team meetings, etc.) and ensure documentation in the form of agendas and minutes.
- Develop and oversee the production and timely distribution of site binders.
- Manage the development and implementation of patient recruitment and patient retention strategies and oversee and track study enrollment.
- Participate in the development and review of Case Report Forms to ensure proper data is captured.
- Oversee the distribution, collection, and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File, and for audit readiness.
- Assist Regulatory Affairs as needed to provide accurate and timely reports, such as annual reports or safety reports to the FDA and other regulatory bodies.
- Ensure clinical project audit and inspection readiness through the study lifecycle and contribute to CAPAs as required.
- Collaborate in the assessment of project risks and develop and implement study-level risk management plans and reviews.
- Oversee clinical trial(s) to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.
- Lead and coordinate the development of clinical study reports (interim, annual, and final) in collaboration with cross-functional team members to support regulatory submissions.
Your Qualifications
- In-depth understanding of ICH GCP Guidelines and other local or international guidance, regulation, and codes of practice related to the execution of clinical trials.
- Organizational awareness to operate in cross-functional teams and provide leadership to other clinical staff members.
- Must recognize and commit to a sense of urgency, teamwork.
- Ability to take and maintain initiative.
- Possess strong interpersonal skills with the ability to manage and mentor others, interact with peers, medical professionals, consultants, and Regulatory Agencies as required.
- Effective time management skills with the ability to plan, prioritize, organize, and problem-solve independently with the use of critical thinking skills.
Your Education and Experience
- Bachelor's or Master's degree within life sciences or a related field.
- 3+ years of clinical research experience, including previous monitoring experience.
- Prior experience (1-3+ years) in the planning, conduct, and management of clinical trials, with a strong preference given to ophthalmic device experience.
- Current ICH GCP certification.
Your Benefits
- An estimated salary range of $120,000 - $180,000 annually, based on qualifications and experience.
- A comprehensive benefits package, including medical, dental, and vision coverage for team members and dependents.
- A 401(k) retirement savings plan.
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