Senior Clinical Project Manager

Arcellx is a venture-backed, early-stage biotech company focused on the development of novel cell-based cancer therapies.  The company is in Gaithersburg, Maryland and the SF Bay Area, and has assembled a team of biotechnology professionals with expertise in biologics discovery, characterization, and clinical development.  Lead products will incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells.

Primary Objective:

The Senior Clinical Project Manager (CPM) will participate in tasks as part of a multi-disciplinary team through the lifecycle of the studies from design through final analysis and study closeout. The individual will perform a variety of complex tasks while overseeing clinical trials from study design through close out; establishing and managing relationships with assigned investigator sites, vendors, and consultants to ensure timelines and deliverables are met and that studies are conducted in accordance with appropriate regulatory requirements.

Main Accountabilities:

• Act as Primary CPM for one or more assigned studies
• Provides input into protocols, amendments, and informed consent forms during all aspects of the studies.
• Assists with selection of vendors and provides oversight to vendors during study start-up through closeout.
• Measures all study related activities by reviewing performance metrics and quality.
• Works independently to ensure studies are conducted within budget and timelines and provides necessary updates and metrics to senior management. Conducts ongoing review of expenses.
• Oversees preparation of all trial related documents including study management plans and provides input to ensure quality oversight of the project(s).
• Provides oversight of Trial Master File to ensure completeness during all aspects of the study.
• As primary sponsor contact for study team and investigators, manages relationships with sites, vendors, and other internal and external team members.
• Participate in process improvement activities resulting in increases in productivity, quality, and/or cost effectiveness
• Provides input in ongoing and final clinical data review in conjunction with Data Management.
• Recommends strategies for, and oversees, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment, and data consistency.
• Leads and/or contributes to department initiatives and assists in the design and implementation of standardized work processes as applicable.

Preferred Qualifications:

• Minimum BA/BS in scientific or health-related field.
• Minimum of 8 years of clinical project management experience in the pharmaceutical industry working in oncology
• Expert and knowledgeable regarding GCP and regulatory requirements
• Proficient with Medidata RAVE.
• Superior communication skills, both verbal and written
• Ability to multi-task and take on new responsibilities as needed in a fast-paced, small company setting.
• Experienced using Microsoft Office applications (Word, Excel, PowerPoint, etc.)
• Strong organizational skills and ability to prioritize tasks.
• Ability to work independently with minimal supervision.

Competencies:

• Must have strong organizational skills and an ability to handle track and execute multiple priorities.
• Highly motivated, with willingness to acquire new skills and ability to learn quickly.
• Detail oriented, good documentation practices, technical writing and verbal communication skills
• Possess problem solving and analytical skills and be an independent and creative thinker.
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
• Interpersonal and leadership skills to work with teams in different functions and organizations.

Without exception, applicants must submit both a cover letter and resume to be considered for these positions and must have experience in one of the fields listed above.