Clinical Trial Management Associate / Sr. CTMA

  • Job Reference: 871066866-2
  • Date Posted: 12 January 2023
  • Recruiter: Neogene Therapeutics
  • Location: Santa Monica, California
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Permanent

Job Description

Pushing the frontier of solid cancer therapy, Neogene Therapeutics is a global, preclinical stage biotechnology company built on the premise of innovation and novel paradigm-changing science. Using tumor mutation profiles to engineer fully individualized T cell therapies, Neogene is bringing new hope to address the current limitations of treatments available today.

We offer the opportunity to join a highly dynamic biotech with locations in Amsterdam, Netherlands and in Santa Monica, CA. You can expect a collaborative environment created by a team with deep scientific expertise and an industrial track-record in T cell therapies.

Neogene values pro-active team-players who pursue their goals with dedication, endurance, and a daring mindset. If you share our commitment to make a difference to patients in need, we can provide an exciting opportunity for your career.

Position Summary

The Clinical Trial Management Associate (CTMA) with Oncology/Cell-Therapy experience will work remote with office hours if there are required in-person meetings. They will support the Manager, Clinical Operations in the conduct of clinical trials sponsored by Neogene. This individual will have responsibilities for aspects of the clinical trial to assist with study start-up, enrollment, maintenance, and close-out. This position is located in Santa Monica, CA and reports directly to the Director, Clinical Operations in the U.S.

Essential Functions and Responsibilities
  • Support all operational aspects of assigned clinical trial(s), including conduct of study start-up, enrollment, study maintenance, and close-out.
  • Assist with the development, oversight, and/or completion of the clinical documents including, but not limited to:
    • Clinical study protocol
    • Informed consent form template (master and/or country-level)
    • Cell therapy product procedure manual and related forms
    • Clinical monitoring/management plan including report templates
    • Training slides and materials (e.g., SIV slides, protocol training materials)
    • Investigator Site File (ISF) structure and template documents
    • Others as needed study-specific documents, plans, charters, tools, trackers, etc. (including that of the CRO)
  • Contributor and reviewer of the clinical documents below:
    • Clinical laboratory manual and requisition forms
    • CRFs and CRF completion guidelines
    • Interactive Response Technology (IRT) manual (e.g., IVRS, IWRS, IXRS)
    • Central imaging manual
    • Edit check / data review plan
    • Data review board charter (e.g., DSMB, SRC)
    • Safety management plan and SAE report form template
  • Manage and/or support the Manager, Clinical Operations with oversight of the Trial Master File (TMF). Responsibilities include, but not limited to:
    • Filing clinical documents in the Trial Master File (TMF)
    • Assisting with the development, oversight, and/or completion of the TMF index and TMF management plan.
    • Periodically reviewing the TMF for reconciliation and QC, following up with the clinical sites, clinical trial monitors, and/or vendors to close-out TMF-related issues.
  • Support the Manager, Clinical Operations with various meetings, may include assisting in developing meeting agendas, writing meeting minutes, and facilitating review of minutes:
    • Internal study team meeting
    • Other internal clinical operations meetings
    • Working group meetings
    • CRO/vendor meetings
  • Support the Manager, Clinical Operations in the selection process of vendors and/or contractors supporting a study, including but not limited to:
    • CRO
    • Clinical trial monitors
    • Central lab
    • Central imaging
    • EDC system
    • IRT system
  • Support the Manager, Clinical Operations in overseeing, managing, and tracking performance of assigned vendors selected for a clinical study which could include acting as a point of contact as delegated by the manager, facilitating review of vendor study specific documents, tracking performance indicators for vendors, creating and maintaining a vendor-specific issues log.
  • Ensures documentation of training for internal study team, vendors, third party contractors, and sites.
  • Help manage, oversee, and track performance of clinical sites selected for a clinical study, which could include acting a point of contact for the sites.
  • Facilitate sponsor review and approval of site-specific documents (e.g., site-specific ICF, patient facing materials, etc.).
  • Proactively identifies potential study issues/risks and recommends/implements solutions.
  • Participate in the development, review and implementation of departmental SOPs and processes.
  • Contribute to the selection of contractors or FTEs that join Neogene.
  • Other duties as assigned.
  • A Sr. CTMA may be delegated lead rather than supporting roles for the duties described above as determined by the study manager and/or Director, Clinical Operations. A Sr. CTMA may be responsible for mentoring junior-level clinical operations team members.
Required Skills/Abilities
  • A minimum requirement of a BA/BS or equivalent degree.
  • In addition, 1-2 years of direct experience in clinical operations supporting clinical drug development within the oncology and/or cell therapy space; OR minimum 3 years of direct experience in clinical operations supporting clinical drug development with no experience in cell therapy clinical studies.
  • Experience and/or knowledge of transplant patient care and apheresis collection for clinical trials strongly preferred.
  • Experience participating in the selecting and managing of CROs and other clinical trial vendors (e.g., central lab, central imaging, etc.).
  • Thorough knowledge and understanding of ICH guidelines, GxPs for conduct of clinical trials, and FDA and EMA regulations.
  • Outstanding organizational skills with the ability to multi-task and prioritize.
  • Excellent interpersonal, verbal and written communication skills, while being able to work and think independently, to support a collaborative work environment.
  • Skilled analytical and problem-solving skill; and be able to proactively identify and communicate risks and/or other issues and develop appropriate mitigation, action plans, or solutions in collaboration with key stakeholders.
  • Proficient clinical research knowledge and cross-functional understanding of clinical trial methodology with proven ability to execute clinical trials within expected timelines.
  • Ability to deal with time demands, incomplete information, or unexpected events
  • Attention to detail required.
  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
  • Relevant clinical cell therapy experience will also be taken into consideration.
The anticipated salary range for candidates who will work remotely is $85,000 to 115,000 with a bonus target of 10%. In lieu of equity, candidates are eligible to receive a cash retention bonus provided that the candidate remains employed through the first and second work anniversaries. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, etc. Regular, full-time employees who regularly work an average of 30 hours or more a week, and their dependents, are eligible for to participate in our benefits program. Dependents include your spouse or domestic partner and dependent children up to the age of 26. Unless otherwise indicated, benefits begin on your first day or start date. Benefits include medical, dental, vision, along with financial programs such as a Flexible Spending Account (FSA), Health Savings Account (HSA), Basic Term Life and AD&D Insurance, 401(k) Retirement Savings Plan and optional employee paid benefits. Please see job description below.

Job Title: Clinical Trial Management Associate / Sr. Clinical Trial Management Associate (Oncology/Cell-Therapy, In-house, Contract)

FLSA Category: Exempt

Department: Clinical Development

Reports to Title: Director Clinical Operations

Position Summary

The Clinical Trial Management Associate (CTMA) with Oncology/Cell-Therapy experience will work remote with office hours if there are required in-person meetings. They will support the Manager, Clinical Operations in the conduct of clinical trials sponsored by Neogene. This individual will have responsibilities for aspects of the clinical trial to assist with study start-up, enrollment, maintenance, and close-out. This position is located in Santa Monica, CA and reports directly to the Director, Clinical Operations in the U.S.

Essential Functions and Responsibilities
  • Support all operational aspects of assigned clinical trial(s), including conduct of study start-up, enrollment, study maintenance, and close-out.
  • Assist with the development, oversight, and/or completion of the clinical documents including, but not limited to:
    • Clinical study protocol
    • Informed consent form template (master and/or country-level)
    • Cell therapy product procedure manual and related forms
    • . click apply for full job details