Overview
Remote
$60 - $70
Contract - W2
Contract - Independent
Contract - 12 Month(s)
Skills
Life Sciences
Research and Development
Clinical Trials
Clinical Research
Functional Requirements
DevOps
Regulatory Compliance
User Stories
Job Details
Job Title: Business Analyst with Clincal/R&D Pharma
Location: REMOTE
Contract-12 months
Job Description:
We are seeking a skilled and detail-oriented Business Analyst to join our Life Sciences R&D team. The ideal candidate will have hands-on experience in gathering and translating user and functional requirements, with a strong understanding of clinical research workflows, informed consent processes, and electronic data capture systems particularly Medidata Rave.
Key Responsibilities
Collaborate with cross-functional teams to elicit, analyze, and document business and functional requirements for clinical research initiatives.
Translate complex business needs into clear user stories, wireframes, and specifications for development teams.
Lead workshops and stakeholder interviews to gather insights on informed consent workflows and data capture needs.
Develop and maintain documentation such as User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Data Definition Specifications (DDS)
Support the design and implementation of solutions that align with regulatory standards and clinical lifecycle processes
Interface with technical teams to ensure seamless integration of Medidata Rave and other tools into clinical trial operations .
Contribute to process improvement initiatives by leveraging domain expertise and agile methodologies
Required Qualifications
Bachelor s or Master s degree in Life Sciences, Information Systems, or related field.
5+ years of experience as a Business Analyst in the life sciences industry, with a focus on R&D.
Proven experience with Medidata Rave or similar EDC platforms.
Strong understanding of informed consent processes and regulatory compliance in clinical trials.
Familiarity with clinical data flow, pharmacovigilance, and patient data management
Excellent communication skills with the ability to convey technical concepts to non-technical stakeholders.
Experience working in agile environments and using tools like Azure DevOps for backlog and sprint planning 6.
Preferred Skills
Ability to manage multiple priorities and deliver high-quality outcomes under tight deadlines.
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