Clinical Study Physician

Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is a fully remote role! The Study Physician (SP) is a critical global role that is created to fulfill aspirations of the client Medicine Excellence 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. SP work towards transforming client into a highly competitive performance organization by living target behaviors and AAI principles. Accountabilities

• Responsibility for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with CTL, CPL, Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates.
• Timely preparation of high medical quality CTP, which supports to avoid CTP amendments.
• Strong contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct.
• Timely provision of medically relevant critical data/process, related risks, and its mitigation/ monitoring strategies to the trial team.
• Medical responsibility as co-author for development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP.
• Responsibility for providing medical input into definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs.
• High quality and timely medical contribution to trial CQMP (and its amendments).
• 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.
• Take medical responsibility for agile & adaptive risk based Clinical Quality Monitoring of critical data. Support close to real time clinical data Ongoing medical review with transparent documentation of the activity, related findings, and its resolution.
• Timely and ongoing monitoring of medical data to avoid the need for late-stage reviews and queries and ensure the adherence to trial timelines medical oversight by using advanced technologies and systems. Proactively address/ communicate clinical quality issues in a collaborative environment.
• Contribution to the timely preparation of medically relevant core trial documents and timely milestones.
• Medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing, “Information for CRF completion” (ICC), Data Review Plan , laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts etc..
• Responsibility for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, Trial Statistical Analysis Plan (TSAP) etc… Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report.
• Timely contribution to the core study documents. Availability of high-quality study documents from medical perspective
• Contribution 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.
• Response to medical queries from Investigators, CROs and/or Sponsor team representatives and contribution to maintenance of trial FAQ log/list.
• Building network with experts and active contribution to site engagement. Support of Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM perspective.
• Medical questions are responded in a timely manner and with state-of-the-art medical expertise. Delivery of high-quality data from medical perspective

Minimum Education/Degree Requirements

• Physician (MD) (ideally with medical thesis), trained in a clinical setting, and minimum of 4 years of active clinical practice experience; specialization in internal medicine or general practice is desirable.

Required Capabilities (Skills, Experience, Competencies)

• Excellent communication skills and team spirit.
• 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 and team.
• Displays the ability to use digital technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment.
• Excellent interpersonal, active listening, influencing skills and fluency in English, both written and spoken

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