Clinical Research Director jobs in Yonkers, NY
Clinical Research Director directs and oversees the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Clinical Research Director ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Requires an advanced degree. Additionally, Clinical Research Director typically reports to top management. The Clinical Research Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Clinical Research Director typically requires 5+ years of managerial experience. (Copyright 2024 Salary.com)
Recently Added Clinical Research Director jobs
Director, Clinical Research
- 5Y9 Pfizer R&D UK Limited
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New York, NY
FULL_TIME
- ROLE SUMMARY The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for Clinical Trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety. The clinician medical monitor may be required to design a development strategy for multiple protocols designed to obtain worldwide approval for a compound or group of compounds. In addition to study level activities, the clinician medical monitor may participate in standing committees, review compounds for potential in-licensing, including performance of due diligence reviews, and provide assistance to new business development on market opportunities and the target product profile. ROLE RESPONSIBILITIES In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required. ROLE RESPONSIBILITIES Accountable for safety across the study: Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level. Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP). Consistent with the SSRP, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead. As appropriate, the clinician medical monitor may delegate these responsibilities to the study clinician scientist identified in the SSRP. The specific components of safety data review are detailed in the appropriate SOPs and the “Safety Data Review Guide – for Clinicians.” Monitor study safety issues and provide input to serious adverse events (SAEs) reports. Provides appropriate medical context in terms of risk factors, medical history and other important medical factors required to put the SAE or AE into appropriate medical context required for benefit-risk assessments. Participates in the Safety Review Team to evaluate medical benefits/risks to support targeted clinical indications. Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study. Communicates safety information to sites across the study and provides responses to questions on safety. Protocol design and strategy: Provide medical input during development and updates to the clinical development plan. Designs clinical studies to meet the stated objectives. Assures that clinical trial objectives fit with the clinical program strategy. Ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy and has been reviewed by IRB/IECs. Provides medical input into country feasibility. Support study team Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team). Contributes to contract research organization / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied. Works with study team to ensure high quality of data e.g. appropriate patient population, adequacy of clinical assessments as study is ongoing. Conducts medical review and interpretation of efficacy and safety data from clinical trials; this may include delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting. Ensures the medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions (ClinicalTrials.gov, EudraCT, or Pfizer.com). Provides protocol specific training to study team, investigators, clinical research associate, and others. Interacts with healthcare professionals at sites (leveraging the RMMs when assigned) during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level. Interacts with DMCs and steering committees as required. Notify appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events. Monitor investigator compliance with protocol and regulatory requirements. Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc. Supports the program team: Authors clinical sections of regulatory documents (Investigator Brochure, Annual Reports, Investigational New Drug sections, clinical study report). May co-author abstracts, posters, presentations and publications. May contribute budget execution of protocols Interact with regulatory authorities, key opinion leaders, and principal investigators: Supports Clinical Regulatory Authority interactions accountable for providing responses. Liaise with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders /Principal Investigators network for new trials QUALIFICATIONS Indicate basic and preferred qualifications: Basic Qualifications are job related, consistent with business requirements and necessary for the performance of an essential function of this role including: education/licenses/certifications, location, relevant experience, technical and/or other job-related skills. Basic qualifications determine minimum requirements that applicants must possess to be qualified for the role; anyone who does not meet basic qualifications for the role will not be interviewed or eligible for hire. Preferred Qualifications are job-related qualifications that may be indicated in addition to basic qualifications; they are not absolutely required for performance of the job but are desired and further describe the education/skills/experience sought for the position. Preferred qualifications enhance a candidate’s ability to perform the job. BASIC QUALIFICATIONS Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year), and has utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least one year. Possesses the ability to critically evaluate medical/scientific information. Excellent written an oral communication. Understands the design, development, and execution of clinical programs and studies. Capacity to adapt to a fast pace and changing environment. Documented experience in the pharmaceutical industry related to clinical research programs and registration activities. Responsible for managing multiple studies PREFERRED QUALIFICATIONS Medical degree (M.D./D.O. or equivalent). Documented work experience/knowledge of statistics. Training and experience in infectious diseases and/or infection control in the hospital setting is preferred. Experience with investigational clinical trials is preferred Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Work Location Assignment: On Premise The annual base salary for this position ranges from $213,500.00 to $355,800.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Medical Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
- 18 Days Ago
Clinical Research Associate
- Cognitive Research Corporation
-
New York, NY
FULL_TIME
- Position Summary: The Clinical Research Associate is responsible for tracking and maintaining study specific non-CRF databases and administrating clinical research projects. This is accomplished by co...
- 24 Days Ago
Senior Associate Director for Clinical Research
- NYU Langone
-
New York, NY
FULL_TIME
- The NYU Langone Vaccine Center at the NYU Grossman School of Medicine invites applications for Senior Associate Director for Clinical Research at the Associate Professor or Professor level. The positi...
- 24 Days Ago
Associate Director - IT Clinical Research Systems
- NYU Langone
-
New York, NY
FULL_TIME
- NYU Grossman School of Medicine is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to ...
- 3 Days Ago
Executive Director, Early Clinical Research Physician
- Schrödinger
-
New York, NY
FULL_TIME
- Schrödinger Therapeutics Group is seeking a physician-scientist to serve as an Executive Director, Clinical Research working on novel oncology compounds in the early stages of development, from First-...
- 24 Days Ago
Associate Director - IT Clinical Research Systems
- NYU Grossman School of Medicine
-
New York, NY
FULL_TIME
- is one of the nation's top-ranked medical schools. For 175 years, NYU Grossman School of Medicine has trained thousands of physicians and scientists who have helped to shape the course of medical hist...
- 2 Months Ago
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0 Clinical Research Director jobs found in Yonkers, NY area
Clinical Trials Manager - Tisch Cancer Institute
- Mount Sinai Hospital
-
New York, NY
- Job Description As the Clinical Trials Manager, you will coordinate and manage multiple clinical trial projects and prot...
- 4/18/2024 12:00:00 AM
Assistant Director Nursing (Yonkers, NY, Us)
- Montefiore
-
Yonkers, NY
- Assistant Director Nursing: As the academic medical center and University Hospital for Albert Einstein College of Medici...
- 4/18/2024 12:00:00 AM
Travel Physical Therapist-Pennsylvania
- Hiring Now!
-
Dobbs Ferry, NY
- Overview: Explore ATI (Passport and Launch) are travel programs for physical therapists that offers short term and long ...
- 4/17/2024 12:00:00 AM
Travel Physical Therapist-Iowa
- Hiring Now!
-
Dobbs Ferry, NY
- Overview: Explore ATI (Passport and Launch) are travel programs for physical therapists that offers short term and long ...
- 4/17/2024 12:00:00 AM
Director, Clinical Research Operations
- NYU Rory Meyers College of Nursing
-
New York, NY
- Position Summary Provide strategic and operational oversight for the NYU Dentistry Translational Research Center and NYU...
- 4/16/2024 12:00:00 AM
Travel Physical Therapist-Alabama
- Hiring Now!
-
Dobbs Ferry, NY
- Overview: Explore ATI (Passport and Launch) are travel programs for physical therapists that offers short term and long ...
- 4/15/2024 12:00:00 AM
Travel Physical Therapist-Georgia
- Hiring Now!
-
Dobbs Ferry, NY
- Overview: Explore ATI (Passport and Launch) are travel programs for physical therapists that offers short term and long ...
- 4/15/2024 12:00:00 AM
Director of Nursing
- Coda Staffing
-
Englewood Cliffs, NJ
- Job Description Job Description Responsibilities, but not limited to the following: Developing and maintaining written o...
- 4/14/2024 12:00:00 AM
About Yonkers, New York
Yonkers (/ˈjɒŋkərz/) is a city in Westchester County, New York. It is the fourth most populous city in the U.S. state of New York, behind New York City, Buffalo, and Rochester. The population of Yonkers was 195,976 as enumerated in the 2010 United States Census and is estimated to have increased by 2.5% to 200,807 in 2016. It is an inner suburb of New York City, directly to the north of the Bronx and approximately two miles (3 km) north of the northernmost point in Manhattan.
Yonkers' downtown is centered on a plaza known as Getty Square, where the municipal government is located. The downtown...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Director jobs
$164,426 to $221,967
Yonkers, New York area prices
were up 1.6% from a year ago
were up 1.6% from a year ago
What does a Clinical Research Director do?
Clinical Research Director in Killeen, TX
We are Looking for an Assistant Director for the Center for Clinical Research Education.
December 07, 2019
Clinical Research Director in Springfield, IL
During the Clinical Research Operations Forum a few weeks ago, Stephen Sonstein, Ph.D., Professor & Program Director for Clinical Research Administration at Eastern Michigan University spoke on the shift in clinical research going from a focus on regulatory compliance to a standardization of competencies for professionals working in the field.
February 06, 2020
Clinical Research Director in Olympia, WA
You might occasionally be able to enter from the administration side - for example, you could start as a study-site coordinator in the NHS or as a clinical trials administrator.
January 28, 2020