Study Physician - FSP

Parexel • Remote (Any Region, United States of America) • 3w ago

Job Summary:

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

Accountability/Supporting Activities:

Trial Start-Up

Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with the Clinical Trial Lead (CTL), Clinical Program Lead (CPL), Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP. Medical input into CTP updates.
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.
Medical responsibility as co-author for the 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.
Responsible for providing medical input into the 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.
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 (e.g., propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts.
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. Support close to real time clinical data medical oversight by using advanced technologies and systems.
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) (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.
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

Skills:

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

Knowledge and Experience:

4+ years 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.

Education:

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.

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