- Work closely with clinical team members within the assigned project to execute assigned activities associated with the conduct of a clinical trial
- May lead or support trial level activities for one or more trials with a level of supervision.
- Responsibilities include, but are not limited to:
- Literature review
- Development of Protocol and ICF documents / amendments, and may present these to governance committee and development team meetings
- Submission of clinical documents to TMF
- Development of site and CRA training materials and presentation at SIVs and Investigator meetings.
- Review clinical narratives
- Monitor clinical data, issue and resolve data queries
- Monitor clinical data for specific trends
- Develops Data Review Plan in collaboration with Data Management
- Responsible for ensuring CRF design adequately supports collection of data in alignment with the protocol in collaboration with Data Management/Programming
- Site-interface in collaboration with trial physician as point of contact for clinical questions
- Clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.))
- Support study committee (e.g., DMC, Steering Committee, Advisory Board, etc) logistics and presentation development
- May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross functional study team members
- Collaborate and liaise with external partners (EG, KOLs, etc) for scientific advice
- Seek out and enact best practices with instruction
- Provide regular and timely updates to manager/management as requested
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Ability to understand assigned protocol(s) and their requirements
- Detail-oriented with commitment to quality
- Basic knowledge and skills to support program specific data review and trend identification
- Basic knowledge of disease area, compound, current clinical landscape
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
- Intermediate medical writing skills and medical terminology
- Intermediate critical thinking & problem solving skills
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
- Basic planning/project management skills (develop short range plans that are realistic and effective
- Moderate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)
- Degree in Life Sciences (MD, PhD with 0-2 years of prior clinical research experience, or PharmD, MS, RN or other scientific degrees with at least 2 years of clinical research experience preferred).
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Associate Clinical Scientist, Oncology
2 weeks ago
BioSpace Princeton, United StatesJob Details · Working 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 ...
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Associate Clinical Scientist, Oncology
2 weeks ago
Bristol Myers Squibb Princeton, United StatesWorking 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 ...
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Associate Clinical Scientist, Oncology
3 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 ...
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Bristol Myers Squibb Princeton, United StatesWorking 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 ...
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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 ...
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Bristol-Myers Squibb Company Princeton, United States**Working 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 li ...
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Bristol-Myers Squibb Company Princeton, United States**Working 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 li ...
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Bristol-Myers Squibb Company Princeton, United States**Working 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 li ...
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Bristol-Myers Squibb Company Princeton, 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 ...
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Bristol-Myers Squibb Company Princeton, United States**Working 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 li ...
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Bristol-Myers Squibb Company Princeton, United States**Working 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 li ...
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Bristol-Myers Squibb Company Princeton, United States**Working 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 li ...
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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 li ...
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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 li ...
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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 ...
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Johnson & Johnson Somerville, United StatesJob Description · Principal Medical Writing Scientist, Oncology At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex di ...
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Regeneron Pharmaceuticals, Inc Bernards, United States Full timeWe are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of ...
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Regeneron Pharmaceuticals, Inc. Basking Ridge, United States Full timeWe are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of ...
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Associate Director, Clinical Scientist, Oncology
4 weeks ago
Regeneron Pharmaceuticals, Inc Basking Ridge, NJ, United StatesWe are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of ...
Clinical Scientist, Oncology - Princeton, 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:
Job Description
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
Uniquely Interesting Work, Life-changing Careers
With 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 ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.
The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.
For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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.
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.