Clinical Scientist

Job 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, the following:

• Provide scientific leadership and guidance for established protocols, and all applicable SOPs. Ability to work independently with minimal supervision.

Specific Requirements:

• 3-5 yrs. Experience in hematology/oncology; experience in Multiple Myeloma (a plus)

• Proficient at data review and interpretation

• Knowledge of clinical trial design, basic statistics, and data review tools

• 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 GCP 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

Additional Requirements:

• 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

• Oncology/Hematology experience (required)

• Data review and medical monitoring of data (required)

• Registry experience (plus)

• Protocol authoring (plus)

Qualifications:

• 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)