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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