Clinical Trial Manager

3 weeks ago

New York, United States Cellectis Full time
Job Description

WHO WE ARE

Cellectis is a global clinical-stage biopharmaceutical company. Pioneers and innovators in our field, our mission is to develop innovative treatments for patients with unmet medical needs.

With 25 years of expertise, we have the best-in-class gene editing platform focusing on hematology oncology, solid tumors and gene therapy. Through our efficient and precise TALEN® technology, we create allogeneic CAR-T cells capable of recognizing and combating cancer cells.

Today, our three clinical programs target patients suffering from B-cell acute lymphoblastic leukemia (B-ALL), non-Hodgkin lymphoma (NHL) and acute myeloid leukemia (AML).

Fully integrated, we are one of the few end-to-end gene editing, allogeneic CAR T-cell companies. With our in-house manufacturing, we control our gene and cell therapy process from start to finish with starting materials produced in Paris (France) and CAR-T therapy products created in Raleigh, NC (USA).

Cellectis' expertise does not stop there - We also have several ongoing strong collaborations, based on our TALEN® technology, with leading cell & gene therapy companies, including our recent partnership with AstraZeneca, to develop new product candidates in oncology, immunology, and treatment of rare diseases.

At Cellectis, we are committed to a cure.

WHY JOIN US?

At Cellectis, our strength as a global organization lies within the collective diversity of the backgrounds, experiences, cultures and perspectives of our colleagues and teams.

We are ONE team of more than 220 employees dedicated & engaged colleagues working towards one mission.

We are gamechangers in the cell and gene therapy field- we invented the allogeneic approach and are the first company to create gene edited allogeneic CAR T-cells.

We constantly innovate and improve to make the best product possible. We address problems with new and creative solutions.

We are committed to an equitable and inclusive work environment where you can be yourself to reach your potential.

Clinical Trials Manager

Purpose

The Clinical Trial Manager is responsible for supporting clinical study teams in the execution of clinical trials. Primary responsibilities include assisting the study lead(s) in the execution and coordination of activities required to initiate, manage and complete clinical trials in accordance with Company SOPs, ICH/GCP regulations and study-specific manuals and procedures. The position may include the oversight and management of assigned operational activities of clinical trial(s)

This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the study lead or VP of Clinical Operations when needed. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Responsibilities
  • Maintain accurate and up-to-date site, vendor and internal study team contact information
  • Assist with study start-up of clinical trials, including feasibility, investigator recruitment, collection of regulatory documents and general site management support
  • Communicate directly with sites to drive collection of essential documents from start-up through study closure
  • In collaboration with the study team, identify risks to study and assist in developing risk mitigation plans, including communication with management when necessary.
  • Review monitoring reports and monitoring visit letters to assess trends and site performance
  • Initiate and/or contribute to the creation and maintenance of documents and plans for assigned clinical studies including but not limited to training materials, plans, operating manuals, presentations, and reports
  • Support the study team in creating and implementing study-specific tools to ensure clean data and timely data entry and may assist in clinical data review and resolution of queries as needed
  • Participate in and manage study team meetings and meetings with CROs, vendors, and multi-functional teams and prepare meeting agendas, minutes, and track action items
  • Manage performance of field CRAs including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to study lead(s) and/or Clinical Operations Management
  • Assist with CRA and third party vendor training on protocols and practices
  • Maintain study tracking including regulatory Q&A, site start-up regulatory timeline, protocol issue tracker, and other study tracking as appropriate
  • In collaboration with the CRO and the study lead(s), establish and maintain the Trial Master File in inspection-ready state
  • Perform and support QC reviews of study, country and site files, including issue resolution
  • May conduct Pre-Study Visits and Site Initiation Visits
  • Support preparing submissions and obtaining approval from local Health Authorities and Ethics Committees
  • Assist with Investigational Product inventory, tracking and shipping to clinical sites and reconciliation
  • Support the negotiations and management of the site budgets and the review of clinical site invoices, in collaboration with the study lead(s) and/or VP, Clinical Operations or designee
  • Track and report on progress of study including but not limited to site activation, patient enrollment, monitoring visits
  • Lead or participate in functional initiatives and/or activities as assigned.
Education and Experience
  • Bachelor's degree or equivalent in life-science is required.
  • At least 4 years of Biotech or pharmaceutical development experience with at least 2 years clinical trial experience is required.
  • Hematology experience is highly preferred.
  • Experience in Phase I-II clinical trials oncology is required.
  • Experience in CRO selection and management is preferred.
  • Knowledge of FDA and GCP/ICH requirements and medical practice/techniques and terminology.
  • Proficient with Microsoft Office (Word, Excel and Power Point) and other electronic systems (CTMS, EDC and eTMF).
Requirements
  • Able to work well within a team and with other accomplished professionals within and across functions/teams
  • Able to work in a fast paced-environment, have the sense of urgency and therefore able to multi-task and shift priorities rapidly to meet tight deadlines.
  • Must have demonstrated problem solving abilities and strong organizational skills.
  • Enthusiastic, self-motivated and keen to improve processes and overcome inefficiencies.
  • Excellent written and verbal communication skills are required.
  • Fluent English is required.
  • Mandatory 4 days per week in office

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