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Study Physician - Oncology - FSP

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Parexel

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Location:
United States

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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Job Description:

The Study Physician (SP) is a critical global role that is created to take up medical responsibilities of clinical trials within Clinical Development & Operations by a qualified and clinically experienced physician. The SP is medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial. During the clinical trial, SP is responsible to provide state-of-the-art medical expertise to fully execute medical oversight from the Trial Design Outline (TDO) kick off to the Clinical Trial Report (CTR). SP is a core member of the Trial Team and the Evidence Network Team.

Job Responsibility:

  • Trial Start-Up: Responsible for medical content of Clinical Trial Protocols (CTPs)
  • Contribution to trial risk-based quality management from medical perspective
  • Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP)
  • Responsible for providing medical input into the definition of important protocol deviations (iPD)
  • Contribution to the timely preparation of medically relevant core trial documents and timely milestones
  • Medical input into Data Management documentation for the trial
  • Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan
  • Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
  • Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs
  • Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans
  • Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff
  • Trial Conduct: Ongoing medical review with transparent documentation of the activity, related findings and resolutions
  • Execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues
  • Responsibility for agile and adaptive risk based Clinical Quality Monitoring of critical data
  • Proactively address/ communicate clinical quality issues in a collaborative environment
  • Early and fast recognition of inconsistencies of medical data and practical difficulties in execution of study protocols
  • Respond to medical queries from Investigators, CROs, and/or Sponsor team representatives and contribute to the maintenance of trial FAQ log/list
  • Building network with experts and active contribution to site engagement
  • Support Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC)
  • Medical review of and contribution to the content of Trial Newsletters
  • Contribution to the scientific publication of trial data, if applicable
  • Leadership: Management of medical activities related to one or more clinical trials
  • Cross functional planning, execution, and analysis of a clinical program
  • Responsible for medical assessments, decisions and medical quality for individual trials, assets and client processes
  • Compliance with Parexel standards: Comply with required training curriculum
  • Complete timesheets accurately and timely as required
  • Submit expense reports as required
  • Update CV as required
  • Maintain a working knowledge of and comply with Parexel processes, ICH-GCPs and other applicable requirements

Requirements:

  • Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
  • Proficiency in written and spoken English and (local language)
  • Excellent interpersonal, active listening and influencing skills
  • Pronounced analytical skills and systematic and well-structured working style
  • Pronounced presentation and training skills
  • Capability to work proactively and with team spirit in an international environment
  • Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment
  • Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities
  • Understanding of relevant regulations and guidance including ICH-GCP
  • Experienced with data visualization systems and IT systems
  • Physician MD, ideally with medical thesis, trained in a clinical setting
  • Minimum of 4 years of active clinical experience
  • specialization in internal medicine or general practice preferred

Additional Information:

Job Posted:
January 16, 2026

Work Type:
Remote work
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