Clinical Scientist

CLINICAL SCIENTIST SUMMIT, NJ Hybrid, 50% Remote. Project Description:

• Provide scientific clinical leadership in conducting extensive data review in RAVE under minimal guidance and oversight from his/her supervisor .
• Review and query of hematology data including but not limited to eligibility criteria, primary efficacy variables, pathology, anti-myeloma therapies, and laboratory data .
• Coordinate with contract research organization (CRO) and liaise with clinical sites for timely data completion .
• Assist the Clinical Research Scientist team to interface with project team members including Clinical Research Physician, Clinical Operations, Study Manager, Data Management, Statistics, Safety, Regulatory and Project Management.
• Support with clinical study report preparation .
• Participate in ad-hoc meetings .
• Support clinical trial activities as requested .
• Responsibilities will include but are not limited to Provide scientific leadership and guidance for established protocols, and all applicable SOPs.
• Ability to work independently with minimal supervision.

• MD preferred, minimum 3-year experience in clinical research development or equivalent .
• Advanced Degree in Life Sciences (e.g., MD, nursing, pharmacy, or related medical field) .
• 3-5 yrs. Experience in hematology/oncology.
• Experience in Multiple Myeloma (a plus) .
• Extensive proficiency in conducting data review in RAVE and interpretation.
• Knowledge of clinical trial design, basic statistics, and data review tools.
• Experience with reviewing and querying clinical data and coordinating with cross functional teams (CROs, clinical physicians, clinical operations, study managers, data management, statistics, safety, etc.).
• Must have knowledge and expertise in MedDRA, Who drug dictionary, TMF, eSub Jreview, Excel and RAVE .
• Knowledge of medical terminology .
• Experience in protocol development and regulatory submissions .
• Full understanding Google Cloud Platform and ICH Guidelines .
• Ability to assimilate technical and scientific information quickly .
• Proficient in Excel, EDC (RAVE) .
• Proficient in Microsoft Office (Word, PowerPoint; Microsoft project) and SAS a plus .
• Excellent written and verbal communication skills and interpersonal skills .
• Be willing to work in an environment where individual initiative, accountability to the team, and professional integrity are required .
• Detail-oriented, well-organized .
• Demonstrated ability to work as part of a team .
• Data review and medical monitoring of data (required) .
• Registry experience is a plus.
• Protocol authoring is a plus.