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Clinical Study Physician- Fsp

4+ years
Not Disclosed
10 April 25, 2025
Job Description
Job Type: Full Time Education: MD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Study Physician- FSP
 

Location:
United States of America, Remote

Category: Medical Sciences
Job ID: R0000033107


About This Role:
Parexel FSP is seeking a Clinical Study Physician for a fully remote position. The Clinical Study Physician (SP) is a vital global role responsible for the medical oversight of clinical trials. The SP will manage the medical content of Clinical Trial Protocols (CTPs), support trial teams with risk-based quality management, and contribute to trial deliverables such as informed consent and clinical trial reports. The SP ensures high medical quality across all phases of clinical trials, from preparation to execution and reporting.


Key Responsibilities:

  • Medical Content Development:

    • Ensure the medical quality of Clinical Trial Protocols (CTPs) in collaboration with the trial team.

    • Provide medical input into CTP updates and ensure timely preparation to avoid amendments.

    • Contribute to risk-based quality management and define relevant critical data, processes, risks, and mitigation strategies.

  • Clinical Quality Monitoring:

    • Co-author the Clinical Quality Monitoring Plan (CQMP) and provide ongoing medical review of clinical data.

    • Execute agile and adaptive risk-based monitoring of critical data, ensuring timely escalation of risks.

    • Monitor and ensure adherence to timelines and medical oversight through advanced technologies and systems.

  • Trial Documentation:

    • Contribute medical input to Data Management documentation, including eCRF design and laboratory parameters specifications.

    • Ensure the quality and timely preparation of core trial documents, such as Patient Information and Informed Consent.

    • Review medical sections of the Clinical Trial Report (CTR) and respond to regulatory and IRB queries.

  • Collaboration and Communication:

    • Provide medical support for patient recruitment, retention plans, and trial feasibility.

    • Respond to medical queries from investigators, CROs, and sponsors.

    • Present medical content to committees such as the Endpoint Adjudication, Data Monitoring Committee, and Steering Committees.


Minimum Education/Degree Requirements:

  • Physician (MD) with a medical thesis, ideally trained in internal medicine or general practice.

  • Minimum 4 years of active clinical practice experience.


Required Skills and Experience:

  • Strong communication and interpersonal skills with the ability to work in a team environment.

  • Analytical, systematic, and structured working style with strong presentation and training abilities.

  • Ability to work proactively and collaborate in an international environment.

  • Expertise in using digital technologies for problem-solving, communication, and learning.

  • Fluency in English, both written and spoken.