77 Clinical Trial Manager Jobs in New York, NY
Jobot is Hiring a Clinical Trial Manager Near New York, NY
Job details
Cutting-edge biotech with patented science, great funding and strong pipeline.This Jobot Job is hosted by Keegan Wade
Are you a fit? Easy Apply now by clicking the "Easy Apply" button and sending us your resume.
Salary $115,000 - $150,000 per year
A Bit About UsCell-based therapy biotech with strong pipeline, experienced leadership and good funding.
Why join us?Unique opportunity to work with some of the most established leaders in this space. Work hand-in-hand with a VP of Development to managed strong pipeline in Phase I and II. Clear path for growth and excellent science, all while being remote based.
Job DetailsPosition Description
The Manager, Clinical Operations manages one or more clinical studies from Protocol Concept to Clinical Study Reporting and Disclosure. This is an exciting opportunity for an individual with a proven track record of managing studies, including internal cross-functional collaboration and coordination, CRO and vendor management to join a dynamic team working to deliver high quality studies on time and within budget. The role is key to ensuring that study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data are acceptable and suitable for regulatory submission. This individual ensures that assigned studies are executed according to ICH/GCP guidelines, applicable regulatory requirements and standard operating procedures.
Essential Duties & Responsibilities
- Managing study progress from start-up to close-out activities and end of study reporting.
- Assuring adherence to intended timelines to achieve study goals while ensuring compliance with international GCP guidelines/regulations and SOPs/SWPs, identifying risks and implementing risk mitigation plans.
- Coordinating interdisciplinary activities throughout the study.
- Oversight and management of CRO and clinical vendors as appropriate to ensure successful conduct of the clinical trial and to ensure data integrity and quality.
- Oversight and management of multiple clinical trials from early development through licensure.
- Lead completion of study deliverables through active participation in all aspects of study design, execution, analysis and reporting, vendor selection and management, and oversight of investigator selection and management.
- Proactively managing study deliverables and milestones, including identifying and resolving trial related issues (quality, timelines, budget, resources).
- Writing clinical related deliverables (e.g., Investigator Brochure, clinical protocol/amendments, Annual Reports/DSUR, eCTD clinical modules, response to FDA questions, etc.)
- Ensure audit readiness at all times by assessing and mitigating study compliance with all regulatory requirements (knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management is required)
- Participate in process improvement initiatives including, but not limited to, contributing to generation of Standard Operating Procedures (SOPs), and collaboration with Clinical Quality and Laboratory staff on study compliance initiatives.
- Provide input in the development of clinical trial related documents including but not limited to protocols, case report forms, informed consents, timelines, monitoring plans, laboratory manuals, training materials, and site initiation visit slide presentation
- Effective communication with KOLs and Investigator site staff to support study delivery.
- Contributing to individual and team development through training initiatives and team building activities
- Bachelor’s degree in biological science, nursing, pharmacy or equivalent as a minimum.
- Minimum 5 years of experience in the pharmaceutical industry in a position performing clinical operations functions.
- Proven track record as a clinical study manager including internal cross-functional coordination and CRO and vendor management to deliver high quality studies to time and budget.
- Previous pharma industry experience Managing early through late studies with preference to early phases.
- Demonstrated experience in the identification of emerging risks and the ability to collaboratively champion solutions within a multi-disciplinary drug development team to help resolve challenges.
- Must possess excellent project planning and priority setting skills, as well as excellent organizational and interpersonal skills and flexibility to accommodate to rapidly changing priorities and deadlines.
- Solid project and vendor management, analytical and problem-solving skills.
- Prior experience with forecasting, tracking and reconciliation of study budgets.
- Prior experience with authoring and coordinating the development of clinical protocols, Investigator brochures and study reports.
- Excellent written and verbal communication skills.
- Monday to Friday
- Remote
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Job Summary
Full Time
$115k-149k (estimate)
05/21/2024
06/17/2024
jobot.com
IRVINE, CA
200 - 500
2014
Private
TIM MURPHY
$50M - $200M
Related Companies
About Jobot
Jobot is a California-based recruiting and staffing firm that provides experienced recruiters for businesses.
The job skills required for Clinical Trial Manager include Clinical Trial, Clinical Operations, Leadership, Initiative, Problem Solving, SOP, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Trial Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Trial Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Trial Manager positions, which can be used as a reference in future career path planning. As a Clinical Trial Manager, it can be promoted into senior positions as a Clinical Research Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Trial Manager. You can explore the career advancement for a Clinical Trial Manager below and select your interested title to get hiring information.
If you are interested in becoming a Clinical Trial Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Clinical Trial Manager for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Clinical Trial Manager job description and responsibilities
Presented overall audit to clinical policy and oversight committee and departmental managers.
02/14/2022: Erie, PA
Before a medical treatment can be administered to the general population, a clinical trial manager needs to oversee a test study.
03/03/2022: Pine Bluff, AR
Clinical trial managers make sure all aspects of clinical trials meet regulatory requirements and scientific standards while protecting patient safety.
02/24/2022: Santa Ana, CA
Clinical Trial Managers are responsible for executing and supervising clinical trials using effective organizational strategies.
03/24/2022: Alamogordo, NM
Learn more about the requirements, responsibilities, training, salary, and job outlook of Virtual Clinical Trial Managers.
01/29/2022: Florence, SC
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Clinical Trial Manager jobs
Communication, feedback, and mentoring are part of a clinical trial manager's job.
02/21/2022: Riverside, CA
Clinical trial managers also hire, train, and evaluate the members of the clinical team.
01/23/2022: Flagstaff, AZ
Without a Clinical Trial Manager to select projects and balance speed with safety, Physicians would waste time researching low-demand medications while putting lifesaving medicines on hold.
04/05/2022: Battle Creek, MI
A clinical trial manager must also possess effective leadership abilities.
03/24/2022: Bangor, ME
Clinical Trial Managers must possess excellent communication skills, leadership ability and multitasking personality.
04/01/2022: Springfield, MA
Step 3: View the best colleges and universities for Clinical Trial Manager.
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