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Clinical Scientist
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Senior Clinical Scientist
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Clinical Biospecimen Expert Scientist
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Clinical Laboratory Scientist
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Clinical Laboratory Scientist
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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 ...
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Clinical Laboratory Scientist
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Clinical Outcomes Assessment Scientist
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Clinical Laboratory Scientist
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Senior Clinical Scientist - Summit, NJ, United States - Bristol-Myers Squibb
Description
Working 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 to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.
Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.
Read more:
Area DescriptionThe Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.
Position Summary / ObjectiveResponsible for implementation, planning, and execution of assigned clinical trial activities.
Serves as Clinical Trial Lead for one or more trialsSuccessfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervisionProvides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)Co-Leads study team meetings in partnership with GDO protocol manager; and collaborate with cross functional study team membersMay support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)Position ResponsibilitiesMaintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team membersPlan and lead the implementation all study startup/conduct/close-out activities as applicableEvaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead)Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)Site-facing activities such as training and serving as primary contact for clinical questionsActivities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS teamClinical data trend identification; provide trends and escalate questions to Medical MonitorDevelop clinical narrative plan; review clinical narrativesProvision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activitiesDrafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)Collaborate and serve as primary liaison between external partners for scientific adviceDegree RequirementsDegree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)Experience Requirements5+ years of experience in clinical science, clinical research, or equivalentProficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operationsProficient knowledge and skills to support program specific data review, trend identification, data interpretationKnowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committeesKey Competency RequirementsExcellent verbal, written, communication and interpersonal skillsMust be able to effectively communicate and collaborate across functions and job levelsAbility to assimilate technical information quicklyRoutinely takes initiativeDetail-orientedStrong sense of teamwork; ability to lead team activitiesProficient in Medical Terminology and medical writing skillsProficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)Proficient critical thinking, problem solving, decision making skillsUnderstanding of functional and cross-functional relationshipsCommitment to QualityAdaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalismProficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting toolsTravel RequiredDomestic and International travel may be required.
The starting compensation for this job is a range from $141,000-$200,000, plus incentive cash and stock opportunities (based on eligibility).The starting pay rate takes into account characteristics of the job, such as required skills and the where the job is performed.
Final individual compensation will be decided based on demonstrated experience.For more on benefits, please visit our for specific benefits listed on our BMS Careers site may vary based on the job and location.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary.
Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
