Back to jobs

Clinical Trial Manager (Temp)

United States, Remote

Caribou Biosciences is a leading clinical-stage CRISPR genome-editing biopharmaceutical company dedicated to developing transformative therapies for patients with devastating diseases. Our next-generation genome-editing technology enables superior precision to develop cell therapies that are armored to potentially improve activity against diseases. We believe the future of cell therapy is off-the-shelf, and we are advancing our pipeline of off-the-shelf, or allogeneic, cell therapies from our CAR-T cell therapy platform as readily available treatments for patients with hematologic malignancies and autoimmune diseases.

Summary of the role:  The Clinical Trial Manager (CTM) works on moderately complex clinical trial activities as the lead of a trial and/or in support of the Clinical Operations Project Leadership Directors. The CTM will work closely with the clinical operations team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The CTM will assist with service provider oversight and management as well as identify issues promptly and escalate to management as appropriate. The CTM supports Clinical Operations in ensuring the financial health of assigned clinical studies and overseeing study milestones.

Responsibilities:

  • Support activities related to all phases of clinical studies including: study/site feasibility, start-up, maintenance, and close-out
  • Manage and oversee study- and site-essential documents review, collection, and tracking
  • Support the initiation, preparation, and maintenance of core study documents (Informed Consent Forms, study plans, site and patient materials, training and guidance documents, and pharmacy-, clinical supply- and laboratory-related documents)
  • Oversee Study Trial Master File (TMF)
  • Ensure required study documents are received, reviewed and filed in the TMF in accordance with GCP and applicable regulations
  • Organize and prepare study-related meetings (agenda, minutes, slides, etc.)
  • Prepare, oversee and maintain study logs (risk, issue, decision logs, etc.)
  • Support and participate in departmental, study team, and service provider meetings
  • Attend study related meetings
  • Participate in study related collaborative process efforts and reviews (protocol development, service provider selection, departmental initiatives, etc.) Complete monitoring visit report reviews and performs co-monitoring or monitoring oversight visits
  • Support, tracks, and triages site and service provider queries
  • Support rapid action to address both internal and site QA findings from audits
  • Manage, coordinate, and oversee the activities from third party service providers including timelines, contract deliverables, metrics, accruals, process planning, and implementation
  • Track and maintain studies, including but not limited to study status, enrollment, deviations, documents, and plans
  • Support oversight of clinical site performance, metrics, and monitoring visits
  •  Assist and supports study data related activities including data review, query creation and resolution, study and protocol deviation reviews, and safety reviews
  • Work cross-functionally with direction from Clinical Operations
  • Review and verifies service provider activities
  • Support study reporting and tracking with applicable systems and technology
  • Support study lead in cross-functional alignment of study timelines
  • Support study lead in financial management of service providers (e.g., contract and invoice reconciliation) Other duties as assigned

Qualifications:

  • Bachelor's degree
  • 7 years relevant work experience
  • Able to demonstrate proficiency in technology use, documentation practices, business practices, version control management, and document control
  • Advanced proficiency in Microsoft 365 suite, including Word, Excel, PowerPoint, Outlook, and SharePoint
  • Strong attention to detail and a commitment to producing high-quality work
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
  • Ability to engage virtually for a standard working day duration, in the style most comfortable to the employee
  • Travel may be required per program or customer needs, but will be discussed and vetted between employee and manager

This position is for a temporary or contract employee who will not be directly employed by Caribou Biosciences. Instead, the individual will be an employee of a third-party staffing firm and their work activities will be managed by the Caribou team. As a temporary/contract employee, you will collaborate closely with Caribou’s internal teams and contribute to our mission while reporting and getting supported by the staffing firm.

 

#Li-REMOTE

 

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...
Select...
Select...
Select...

U.S. Standard Demographic Questions

We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.
Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Caribou Biosciences, Inc.’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.