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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.

CLINICAL-RESEARCH, PROTOCOLS, CROSS-FUNCTIONALLY, MEDICAL MONITOR, TRIALS. 

Recommended skills

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