Clinical Scientist

The Fountain Group is currently seeking a ­­­­­­­­Clinical Scientist for a prominent client of ours. This position is ­­100% REMOTE (based out of Cambridge, MA). Details for the position are as follows:

Job Description:

**100% REMOTE (based out of Cambridge, MA)**

• Lead for development of key clinical documents (protocol/amendments, IB, CSR; working with/without medical writer as needed)
• Reviewer of CRFs, SAPs, TLGs, study manuals impacting endpoint assessment/data collection/analysis (ie, central imaging review charter, blinding plan, data transfer plans for central labs, etc.)
• Perform clinical data reviews (routine clinical science data review/cleaning as well as ad-hoc data/issue evaluation)
• Assess/provide input for issues that may impact clinical trials data generation, collection, and analysis
• Assess/provide input for protocol clarifications/interpretation – includes review and/or authoring of responses to regulators, ie, EC/IRBs, FDA/EMA, etc.
• Development/review of materials for training on the clinical protocol (working closely with operations)
• Assists in requesting/interpreting ad-hoc data analyses
• Reviewer of abstracts/presentations/publications
• As requested, creates clinical data summaries for regulatory submissions, corporate decision making, etc.

Qualifications:

• MS, PhD, or PharmD in a life science or related field
• Strong background in clinical research
• Recent and relevant experience working as a Clinical Scientist
• Experience with systemic mastocytosis OR mast cell disorders Cutaneous mastocytosis Mast cell activation syndrome Hereditary Alpha-Tryptasemia Multiple myeloma

Compensation: BID RATE