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Clinical Trial Manager

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Posted : Sunday, September 01, 2024 08:44 PM

Who We Are Arcellx is a public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases.
We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.
Our team members are made up of talented innovators and dreamers working from our offices in Gaithersburg, Maryland, and Redwood City, California.
At Arcellx, we hire exceptional people and create a fun, diverse, supportive, and informal environment that allows everyone to do their best work.
What Matters to Us Living our core values is essential to maintaining a work environment that is high-performing, inclusive, and collaborative.
We look for candidates who demonstrate strong values alignment and bring different backgrounds, viewpoints, and abilities to the team.
Arcellx Core Values Character: Committed to always doing what's right.
Audacity: Willing to challenge convention and share candid feedback with others.
Determination: Curious and self-motivated.
Always looking to improve and learn.
Collaboration: "No job is too small" mentality.
Humble and willing to help others.
Originality: Will bring your unique perspective to the table and respect a diverse set of views and backgrounds.
How You'll Make a Difference As our Clinical Trial Manager (CTM), you'll be accountable for the day-to-day study management and successful delivery of one or more clinical trials in accordance with the protocol, Arcellx SOPs and good clinical practices (GCP) and applicable regulations.
By managing all aspects of the study including budget and timeline, you'll play a critical role in advancing our life-saving therapy through the clinic and to patients who need it most.
The "Fine Print" – What You'll Do Oversees scope, quality, timelines, and budget with the internal functional leads, CRO, and vendors to ensure overall project objectives are met with minimal oversight from line manager.
Take a leadership role in the assigned site and study management activities, including development of critical study documents, including, but not limited to informed consent form templates, various management plans and study trackers.
Provide study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel.
Effectively communicate expectations to CRO, ensure appropriate site management, hold CRO accountable to timelines, and verify quality metrics.
Anticipates obstacles or complex issues at the site, vendor, and study levels and implements solutions to achieve project goals or to overcome identified obstacles.
Proactively identify issues for escalation, participate in problem-solving and implementation of risk mitigation.
Develop and ensure compliance with clinical monitoring plan; conducts or oversees co-monitor as needed for staff training and quality assurance (QA) purposes.
Review the quality and integrity of the clinical data through review of electronic CRF data.
Work with CRO/sites to resolve data queries.
Skills and Experience We Look For BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent).
8+ years of oncology therapeutic area, CAR-T therapy and early phase research design preferred.
Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and regulatory requirements.
Exceptional project management skills.
Eager to learn with a collaborative, team-oriented mindset.
Excellent written and verbal communication skills with an ability to express complex ideas to study personnel at research and clinical institutions.
Excellent organizational and problem-solving skills with ability to handle several priorities within complex trials.
Rewards at Arcellx Our people are our greatest asset, and supporting their well-being is an essential part of delivering on our mission and impacting the lives of patients.
Putting this belief into practice means offering strong compensation and benefits.
The base salary range for this position is $125,000 - $170,000 per year.
Where a candidate falls within that range is determined by factors such as years of experience.
Our compensation package also includes an annual bonus based on company goals and an equity (RSU) grant.
We do offer relocation assistance for roles if required.
Our market-leading benefits package includes: 100% coverage for medical, dental and vision for team members and dependents, unlimited vacation, a 3-day weekend every month, fully-paid parental leave for up to 6 months, tuition reimbursement, 401k employer contribution and more.
Join us in our quest to reimagine cell therapy and destroy cancer.
For more on our technology, culture, and team, go to www.
arcellx.
com.
#LI-Onsite

• Phone : NA

• Location : Redwood City, CA

• Post ID: 9004530970


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