Arcellx (http://www.arcellx.com/) 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.
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.
- 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.
- 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.
- 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.
Submit cover letter and resume to: firstname.lastname@example.org
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.