- Support the planning and setup, maintenance, and closeout phases of multiple concurrent clinical research studies
- Prepare vendor RFPs; select and manage vendors to ensure high quality study execution and data delivery within the defined timeline and budget
- Provide day-to-day study management including oversight of CRO, study vendors, and investigational sites in coordination with the study team
- Evaluate vendor performance, assess risks, and escalate items as appropriate to the team
- Work jointly with Patient Operations team to manage the patient and drug supply logistics throughout the clinical trial
- Monitor and collaborate with CROs to proactively identify protocol deviation and project risks, and develop mitigation and contingency planning
- Identify and mitigate risks and apply strong problem-solving skills to ensure timely resolution of all project-related issues
- Support program governance with internal and external stakeholders gathering and maintaining records and reports for KPIs, metrics, and milestones
- Monitor and maintain project artifacts (timeline, project management plan, budget etc.) that support team communication, efficiency, and regulatory compliance
- Maintain study dashboards and reports study metrics, risks, and mitigations to leadership team
- Develop strong cross-functional partnerships and routinely collaborate with multiple departments including Clinical Development, Data Management, Translational Science, Regulatory, Quality, and Supply Chain
- Provide input for developing study-related materials, such as kick off materials, meeting agendas, minutes, decision logs, charters, and user acceptance testing plans
- Ensure compliance with FDA and ICH GCP regulations and all internally-controlled documents
- Track and assist with resolution of trial non-compliances, working on corrective and preventative actions as needed
- Prepare and review trial-related reports, including enrollment updates, deviation logs, monitoring trackers, etc.
- Review and maintain project-related documentation including budgets, action items, and deviations
- Track monthly financial data associated with each project and work closely with the Finance team to ensure accurate billing
- Implement changes to remove bottlenecks, improve processes and procedures, and improve the efficiency and effectiveness
- Occasional domestic and international travel may be required
- BA/BS in a relevant scientific discipline or equivalent degree; advanced degree preferred
- 5+ years of clinical research experience in the biotech, CRO, or pharmaceutical industry
- 5+ years of experience managing multi-center clinical trials; experience managing CROs, clinical study vendors, investigational sites, and internal study teams
- Strong understanding of all aspects of clinical trials; early phase oncology experience is preferred
- Prior investigational site experience, CRO monitoring experience, and experience working within a growing biotech company
- Expert knowledge of ICH/GCP, drug development, and clinical research industry practices
- Strong interpersonal skills; excellent oral/written communication and presentation skills
- Ability to build and maintain successful professional relationships with internal cross-functional teams, vendors, and investigational sites
- Strong organizational, project management, and multitasking skills
- Must be able to work in a fast-paced, early phase environment with demonstrated ability to prioritize and execute competing tasks and demands
- Proven problem-solving and analytical skills, and the ability to handle ambiguity
- Advanced working knowledge of MS Office products including Word, Excel, and PowerPoint; preferred skills in MS Project
- Proficiency using required electronic systems (e.g., CTMS, eTMF, EDC)
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Clinical Project Manager - San Carlos, United States - Cargo Therapeutics
Description
Reporting to the VP, Clinical Operations, CARGO Therapeutics is seeking a Clinical Project Manager to support and oversee the day-to-day responsibilities on multiple early phase clinical research trials. The Clinical Project Manager will work with CROs and third-party vendors and closely collaborate with cross-functional internal and external stakeholders to ensure adherence to GCPs, SOPs, and FDA/ICH guidelines and delivery of high quality data within the defined timelines and budget.
The role is based in San Carlos, CA.
WHAT YOU'LL DO AT CARGO THERAPEUTICS
The combined pay range for this role is $128,000 - $176,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role.
ABOUT CARGO THERAPEUTICS
CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO's programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic "cargo" designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO's founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo-
Join us to help make a difference
EEO & EMPLOYMENT ELIGIBILITY
CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law.
CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
