- 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.
- 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).
- 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
-
Clinical Trials Manager
2 days ago
Mount Sinai New York, United States**Description** · The Clinical Trials Manager coordinates and manages multiple clinical trials projects and protocols, including those from pharmaceutical companies. This individual instructs staff regarding appropriate protocols; provides support for ongoing research projects an ...
-
Associate Clinical Trial Manager
2 weeks ago
Lupus Research Alliance Inc. New York, United States**Associate Clinical Trial Manager, Lupus Therapeutics (Contract basis)** · **Location**: Remote · **Remuneration**: $100/hour, up to 25 hours per week · **Background** · The Lupus Research Alliance (LRA) is the world's leading non-governmental, non-profit funder of lupus researc ...
-
Clinical Trials Manager-ob/gyn-13120-001
2 weeks ago
Mount Sinai New York, United States**Description** · The Clinical Trials Manager coordinates and manages multiple clinical trials projects and protocols, including those from pharmaceutical companies. This individual instructs staff regarding appropriate protocols; provides support for ongoing research projects an ...
-
Assistant Manager, Trials
2 days ago
Metropolitan Transportation Authority Jamaica, United States**Description** · **JOB TITLE**: Assistant Manager, Trials & Investigations · **SALARY RANGE**: $85,000 - $94,500 · **HAY POINTS**: 496 · **DEPT/DIV**: Labor Relations · **SUPERVISOR**: Manager, Trials & Investigations · **LOCATION**: Queens, NY · **HOURS OF WORK**: 8:30am - 4:30 ...
-
Clinical Trial Manager
1 week ago
Cellectis New York, United StatesWHO 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 focu ...
-
Clinical Trials Manager
1 week ago
Mount Sinai Hospital New York, United StatesJob Description · As the Clinical Trials Manager, you will coordinate and manage multiple clinical trial projects and protocols, including federally funded studies, investigator-initiated studies, and/or those from pharmaceutical companies. The manager will instruct and trains st ...
-
Clinical Trials Manager
3 weeks ago
Mount Sinai Medical Center New York, United States· As the Clinical Trials Manager, you will coordinate and manage multiple clinical trial projects and protocols, including federally funded studies, investigator-initiated studies, and/or those from pharmaceutical companies. The manager will instruct and trains staff regarding t ...
-
Clinical Trial Manager
1 week ago
Cellectis New York, United StatesJob DescriptionWHO 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 editin ...
-
Clinical Trial Manager
2 weeks ago
Medpace New York, United StatesJob Summary : · Medpace is currently looking for full time Clinical Trial Manager (CTM) to lead global clinical research studies in our Taipei, Taiwan office. Medpace is a scientifically led organization involved in full services for our clients, giving the Medpace project teams ...
-
Clinical Trial Manager
4 weeks ago
Medpace New York, United StatesJob Summary : · Medpace is currently looking for a Clinical Trial Manager (CTM) to lead global clinical research studies. Medpace is a scientifically led organization offering full-service solutions for our clients, giving the Medpace project teams the empowerment to truly lead ...
-
Manager- Clinical Trials
1 week ago
New York Blood Center New York, United StatesOverview: · At New York Blood Center, one of the most comprehensive blood centers in the world, our focus is on cultivating excellence by merging cutting-edge innovation with diligent customer service, groundbreaking research, and comprehensive program and service development. J ...
-
Data Management Trial Manager
1 week ago
Merck Sharp & Dohme Rahway, United StatesThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific drug/vaccine program. Develops and manages project plans which span from protocol development through database lock, archiving, and submis ...
-
Clinical Trials Manager-Psychiatry
1 week ago
Mount Sinai Health System New York, United StatesJob DescriptionThe Clinical Trials Manager coordinates and manages multiple clinical trials projects and protocols, including those from pharmaceutical companies. This individual instructs staff regarding appropriate protocols; provides support for ongoing research projects and p ...
-
Clinical Trial Coordinator Manager
1 week ago
Merck New York, United States Full timeJob Description · This role is accountable for execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, company policies and procedures and with quality standards internally and externally. · Under the oversight of ...
-
Associate Director, Clinical Trial Management
3 weeks ago
i-Pharm New York, United StatesThe base salary range for this position is $170,000 - $190,000. · What you will be Doing · Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:Coordinate site management activities: · Site identification, recruitment, ...
-
Associate Director, Clinical Trial Management
2 weeks ago
iPharm New York, United StatesThe base salary range for this position is $170,000 - $190,000. What you will be Doing Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:Coordinate site management activities:Site identification, recruitment, and sel ...
-
Financial Manager II, Cancer Clinical Trials
1 week ago
Mount Sinai Health System New York, United StatesJob Description · The Cancer Clinical Trials Financial Manager has oversight of all financial and related activities for a large and complex institute, department, center, or unit. Manages departmental financial office; performs analyses to identify revenue collection problems a ...
-
Financial Manager II, Cancer Clinical Trials
2 weeks ago
Mount Sinai Health System New York, United StatesJob Description · The Cancer Clinical Trials Financial Manager has oversight of all financial and related activities for a large and complex institute, department, center, or unit. Manages departmental financial office; performs analyses to identify revenue collection problems a ...
-
Project Manager for Clinical Trials
2 weeks ago
Woodley Equipment Company LTD New York, United StatesJob Description · Job DescriptionBenefits:401(k) · Competitive salary · Dental insurance · Health insurance · Paid time off · Vision insurance · Training & development · Job Title: Study Project Manager for Clinical Trials · Reports To: US General Manager and PM manager · Classif ...
-
Project Manager for Clinical Trials
3 weeks ago
Woodley Equipment Company LTD New York, United StatesJob Description · Job DescriptionJob Title: Study Project Manager for Clinical Trials · Reports To: US General Manager and PM manager · Classification: Salaried, Full-time, Exempt ($50,000 to $55,000) · ABOUT THE ROLEWoodley Trial Solutions which provide a unique range of tailore ...
Clinical Trial Manager - New York, United States - Cellectis
Description
Job DescriptionWHO 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