Clinical Scientist
The Fountain Group
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.
- 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
Vacancy posted 1 day ago
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