Cellectis
Clinical Trial Manager
Cellectis, New York, New York, us, 10261
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.
W
e 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.
ResponsibilitiesMaintain accurate and up-to-date site, vendor and internal study team contact informationAssist with study start-up of clinical trials, including feasibility, investigator recruitment, collection of regulatory documents and general site management supportCommunicate directly with sites to drive collection of essential documents from start-up through study closureIn 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 performanceInitiate 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 reportsSupport 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 neededParticipate in and manage study team meetings and meetings with CROs, vendors, and multi-functional teams and prepare meeting agendas, minutes, and track action itemsManage 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 ManagementAssist with CRA and third party vendor training on protocols and practicesMaintain study tracking including regulatory Q&A, site start-up regulatory timeline, protocol issue tracker, and other study tracking as appropriateIn collaboration with the CRO and the study lead(s), establish and maintain the Trial Master File in inspection-ready statePerform and support QC reviews of study, country and site files, including issue resolutionMay conduct Pre-Study Visits and Site Initiation VisitsSupport preparing submissions and obtaining approval from local Health Authorities and Ethics CommitteesAssist with Investigational Product inventory, tracking and shipping to clinical sites and reconciliationSupport 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 designeeTrack and report on progress of study including but not limited to site activation, patient enrollment, monitoring visitsLead 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/teamsAble 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
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.
W
e 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.
ResponsibilitiesMaintain accurate and up-to-date site, vendor and internal study team contact informationAssist with study start-up of clinical trials, including feasibility, investigator recruitment, collection of regulatory documents and general site management supportCommunicate directly with sites to drive collection of essential documents from start-up through study closureIn 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 performanceInitiate 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 reportsSupport 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 neededParticipate in and manage study team meetings and meetings with CROs, vendors, and multi-functional teams and prepare meeting agendas, minutes, and track action itemsManage 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 ManagementAssist with CRA and third party vendor training on protocols and practicesMaintain study tracking including regulatory Q&A, site start-up regulatory timeline, protocol issue tracker, and other study tracking as appropriateIn collaboration with the CRO and the study lead(s), establish and maintain the Trial Master File in inspection-ready statePerform and support QC reviews of study, country and site files, including issue resolutionMay conduct Pre-Study Visits and Site Initiation VisitsSupport preparing submissions and obtaining approval from local Health Authorities and Ethics CommitteesAssist with Investigational Product inventory, tracking and shipping to clinical sites and reconciliationSupport 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 designeeTrack and report on progress of study including but not limited to site activation, patient enrollment, monitoring visitsLead 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/teamsAble 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