- 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 manuscriptsQUALIFICATIONS
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.
- 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) Special knowledge or skills needed and/or licenses or certificates preferred:
- 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)Travel requirements
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.
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Clinical Scientist - Monmouth Junction, United States - Tris Pharma
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 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
