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Clinical Scientist (21-01870) at Axelon Services Corporation

Clinical Scientist (21-01870)

Axelon Services Corporation Lawrence Township, NJ Contractor
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“This role is currently work-from-home and will move to the office environment after the COVID-19 restrictions are lifted.”

Job Description: Senior Clinical Scientist

R&D / Global Drug Development

The Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.
• Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials
• Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
• Provides 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 members
• May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning)
• Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
• Plan and lead the implementation all study startup/conduct/close-out activities as applicable
• Evaluate 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 questions
• Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
• Clinical data trend identification; provide trends and escalate questions to Medical Monitor
• Develop clinical narrative plan; review clinical narratives
• Provision 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) activities
• Drafting/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 advice
• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
• 5+ years of experience in clinical science, clinical research, or equivalent
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
• Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Excellent verbal, written, communication and interpersonal skills
• Must be able to effectively communicate and collaborate across functions and job levels
• Ability to assimilate technical information quickly
• Routinely takes initiative
• Detail-oriented
• Strong sense of teamwork; ability to lead team activities
• Proficient in Medical Terminology and medical writing skills
• Proficient 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 skills
• Understanding of functional and cross-functional relationships
• Commitment to Quality
• Adaptable / 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 professionalism
• Proficient 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 tools
Domestic and International travel may be required.


Recommended skills

Pre Clinical Development
Medical Writing
Clinical Study Reports
Clinical Research
Electronic Data Capture
Good Clinical Practices (Gcp)
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