- Actively participates in, or leads various aspects of preclinical or clinical data review including, but not limited to: adverse events, efficacy data, patient screening/eligibility evaluation, Pharmacokinetics (PK)/Pharmacodynamics (PD) data, coding and other critical information critical to study endpoints
- Authors, and/or work with external medical writers, to develop clinical documents including, but not limited to: clinical protocols/amendments, briefing documents, Investigational New Drug (IND) annual reports, Investigator's Brochures, clinical study reports and scientific presentations including abstracts, posters and manuscripts
- Partners or leads cross functional teams to mitigate issues in initiation and management of one or more clinical trials and monitor guidelines, IDMS charter, statistical analysis plans, data management and safety management plans
- Ensures clinical data collection proceeds in a manner consistent with strategic objectives and regulatory requirements for reporting (i.e., collaborates with statisticians to produce statistical analysis plans and data displays; provides input to Case Report Form (CRF) design and data management processes; Performs periodic review of clinical data
- Participates in planning for interim data analyses and reviews, including Data Safety Monitoring Board (DSMB) meetings
- Works with the Medical Directors to monitor and evaluate emerging clinical data; Reviews/interprets data to produce strategically relevant abstracts, presentations and manuscripts
- Thorough knowledge of Good Clinical Practices (GCPs), International Conference on Harmonization (ICH) guidelines and regulatory requirements for clinical trial management
- Working knowledge of Electronic Data Capture (EDC) systems (i.e., Inform, Medidata, TrialMaster, etc.)
- Medical writing experience authoring a range of clinical trial documentation (i.e., clinical study protocols, informed consent forms, regulatory forms (IND sections, clinical study reports, Investigator's Brochures), scientific publications/presentations, etc.)
- Working knowledge of medical terminology, MedDRA and World Health Organization (WHO) drug dictionaries
- Proficiency with Microsoft Office
- Excellent verbal and written communication and skills
- Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
- Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
- Fluent in English (verbal and written)
- Advanced degree (MS, MPH, PhD, PharmD, etc.)
- Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) certification (Association of Clinical Research Professionals (ACRP) or equivalent)
-
Principal Scientist, Clinical Research
1 week ago
Merck Sharp & Dohme Rahway, United StatesOur company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to exce ...
-
Late-stage Clinical Scientist
1 week ago
Pfizer New York, United StatesROLE RESPONSIBILITIES · - The Late-Stage Clinical Scientist (Director) is a clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. · - Effectively partners with other cl ...
-
Clinical Scientist
6 days ago
Tris Pharma Monmouth Junction, United StatesApply · Description · Tris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including ap ...
-
Clinical Scientist
1 week ago
Tris Pharma Monmouth Junction, United States Full timeTris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have ma ...
-
Axsome Therapeutics, Inc. New York, United StatesJOB SUMMARY · Axsome Therapeutics is seeking a Clinical Research Scientist or Sr. Clinical Research Scientist (based on experience) that reports to the Clinical R&D function, serves as a critical asset to the Clinical Lead and supports the design and delivery of our clinical tria ...
-
Clinical Laboratory Scientist
1 week ago
KPG Healthcare, LLC Queens, United StatesKPG Healthcare is currently seeking CLS/ MLS/ M - Ts to fill Travel and Local Contract opportunities throughout our network of hospitals. Location - Queens, New York Requirements: Specialty: CLS/ MLS/ MT Certifications: MT through ACSP, State License Scientist, Laboratory, Clinic ...
-
Clinical Laboratory Scientist
1 week ago
KPG Healthcare, LLC Flatlands, United StatesKPG Healthcare is currently seeking CLS/ MLS/ M - Ts to fill Travel and Local Contract opportunities throughout our network of hospitals. Location - Flatlands, New York Requirements: Specialty: CLS/ MLS/ MT Certifications: MT through ACSP, State Lice Scientist, Laboratory, Clinic ...
-
Clinical Laboratory Scientist
5 days ago
ATX Learning New York, United StatesTitle: Clinical Laboratory Scientist Job Code: 500285 · Department/Location: Department of Laboratories FLSA Status: NE · Reports to: Section Laboratory Supervisor · Position Summary · The Clinical Laboratory Scientist performs laboratory testing using both manual and automat ...
-
Clinical Laboratory Scientist
1 week ago
eTeam New York, United StatesJob Title - Clinical Laboratory Scientist · Job Location - New York NY · Contract - 6 Weeks · Rate - 60/hr to 65/hr · Job Description - · Exerts up to 10-15 lbs of force 2. Must be able to work on dead bodies or body parts 3. Must meet the general requirements of the Medical Cent ...
-
Pre-clinical Scientist
6 days ago
Gan & Lee Pharmaceuticals Somerville, United StatesJob Description · Job DescriptionSummary · This position reports to the department head of non-clinical sciences. The Non-Clinical Scientist provides the overall leadership regarding the non-clinical scientific and strategy for an asset and is accountable for meeting all non-clin ...
-
Senior Clinical Scientist
1 week ago
Bristol-Myers Squibb Summit, NJ, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line t ...
-
Clinical Scientist, Oncology
2 weeks ago
Bristol Myers Squibb Princeton, United States OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Clinical Scientist, Oncology
1 week ago
Bristol Myers Squibb Princeton, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Clinical Laboratory Scientist
5 days ago
Saratoga Hospital New York, United StatesSummary of Position: Under the supervision of the department Supervisor, assumes responsibility for performance of routine, standardized biological and/or bio chemical test procedures on blood, urine, tissue, body fluids and other specimen sources that assists clinicians in the d ...
-
Travel Clinical Lab Scientist
1 week ago
TotalMed Allied Queens, United StatesTotalMed Allied is seeking a travel Clinical Lab Scientist (CLS) for a travel job in Queens, New York. · Job Description & Requirements · Specialty: Clinical Lab Scientist (CLS) · Discipline: Allied Health Professional · Start Date: 05/27/2024 · Duration: 14 weeks · 40 hours per ...
-
Manager Clinical Safety Scientist
1 week ago
Daiichi Sankyo, Inc. New Jersey, United StatesJoin a Legacy of Innovation 110 Years and Counting Company is committed to diversity and inclusion · We are an equal opportunity employer including veterans and people with disabilities · Summary · •This position supports proactive safety surveillance and risk management for as ...
-
Travel Clinical Lab Scientist
1 week ago
Voca Brooklyn, NY, United StatesVoca is seeking a travel Clinical Lab Scientist (CLS) for a travel job in Brooklyn, New York. · Job Description & Requirements · Specialty: Clinical Lab Scientist (CLS) · Discipline: Allied Health Professional · Start Date: 05/27/2024 · Duration: 6 weeks · 40 hours per week · Shi ...
-
Travel Clinical Lab Scientist
1 day ago
TotalMed Allied Brooklyn, NY, United StatesTotalMed Allied is seeking a travel Clinical Lab Scientist (CLS) for a travel job in Brooklyn, New York. · Job Description & Requirements · Specialty: Clinical Lab Scientist (CLS) · Discipline: Allied Health Professional · Start Date: 05/20/2024 · Duration: 6 weeks · 40 hours per ...
-
Travel Clinical Lab Scientist
1 week ago
Voca Brooklyn, NY, United StatesVoca is seeking a travel Clinical Lab Scientist (CLS) for a travel job in Brooklyn, New York. · Job Description & Requirements · Specialty: Clinical Lab Scientist (CLS) · Discipline: Allied Health Professional · Start Date: 06/03/2024 · Duration: 6 weeks · 40 hours per week · Shi ...
-
Travel Clinical Lab Scientist
2 days ago
Voca Brooklyn, NY, United StatesVoca is seeking a travel Clinical Lab Scientist (CLS) for a travel job in Brooklyn, New York. · Job Description & RequirementsSpecialty: Clinical Lab Scientist (CLS) · Discipline: Allied Health Professional · Start Date: 06/03/2024 · Duration: 6 weeks · 40 hours per week · Shift: ...
Clinical Scientist - Monmouth, United States - BioSpace
Description
Job DetailsTris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success.
Located in Monmouth Junction, New Jersey, Tris Pharma has an immediate opening for a Clinical Scientist/Grant Administrator
SUMMARY:
The Clinical Scientist supports clinical development programs by actively participating in, and/or leading when appropriate, aspects of the development, oversight and execution of phase I to IV clinical research trials. Collaborating closely with Physicians, Clinical Leaders and other scientific colleagues, the incumbent contributes to the design, data collection and reporting of clinical studies in a manner consistent with industry standards, applicable regulations and clinical development strategy. She/he may author clinical research documents, collect and interpret scientific and medical data, evaluate clinical outcome measures, data review and support all appropriate manner of clinical trial activities. The incumbent primarily provides scientific, operational and administrative support during creation, execution and analysis of grant funded research (preclinical and clinical). She/he may also be required support other clinical development programs, outside the grant, as necessary.
Requirements
ESSENTIAL FUNCTIONS
Minimum education and number of years required of relevant work experience
Bachelors degree or equivalent in a scientific or health care field and minimum 3 years clinical research experience (including medical writing responsibilities) in the pharmaceutical or biotechnology industry.
Special knowledge or skills needed and/or licenses or certificates .
Approximately 25%
Physical requirements
Office based position
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.
#LI-DNI
