(Sr) Medical Director - (CRO Services / Oncology)

Job Title:   Medical Director or Senior Medical Director 

Job Location:   United States or Canada - Remote 

Job Overview:  

Primary responsibilities include medical and safety oversight of clinical trials as well as corporate support for business opportunities.  The Medical Director provides Medical Monitoring services to clinical trials with the aim of monitoring the safety and wellbeing of study participants, integrity of the project data in accordance with the clinical trial protocol/clinical study protocol (or equivalent documents), standard operating procedures (SOPs), good clinical practice (GCP), and all other applicable directives and regulatory requirements. 

Job Duties and Responsibilities: 

Medical Monitoring:

• Provides Medical oversight of projects to ensure GCP/national and international regulatory requirements, Policies/SOPs/WPs, and Sponsor directives are followed.
• Provides Medical consultation to Sponsors and project teams for protocol development and/or project activities, as indicated.
• Maintains availability to the sites and project team including the Sponsor to ensure that medical questions or medical aspects of project-related questions (e.g. safety, general protocol questions, subject eligibility, inclusion/exclusion criteria, screening, randomization, unblinding, dosing, termination and discontinuation, IP-specific questions, etc.) are answered or communicated for resolution.
• Develops/updates the Medical Monitoring Plan (MMP), circulating it for approval within the company and with Sponsor
• Reviews project specific plans, including the Safety Management Plan (SMP).
• Reviews and advises on project-related documents (e.g. study protocol, Informed Consent Form, clinical study report, etc.), as indicated.
• Develops and/or reviews project-related documents and reports, assesses and interprets project results.
• Reviews medical literature in the scope of preparation of project-related documents and provides input for preparation of the respective documents.
• Reviews and assesses issues related to protocol compliance, including protocol deviations/violations, development of the corrective and preventative actions.
• Trains CRAs and other team members on different topics, including medical and/or safety aspects of the project or therapeutic area/indication.
• Attends internal and external project meetings
• Reviews laboratory results and lab/ECG alerts, as required.
• Provides Medical review and assessment of SAEs, adverse events of special interest, SAE narratives, expedited and periodic safety reports, as requested.
• May write medical sections of periodic safety reports (e.g., risk-benefit assessments) and/or review safety data for trends.
• Provides Medical review of study data, as per the MMP/Medical data review plan, for clarifying and resolving data inconsistencies, query management, trend assessment, etc.
• May review requests from Regulatory Authorities and/or Ethic Committees/IRBs and related activities with preparation of responses, when requested.
• Escalates issues and notifies Line Manager, Project Manager, and/or other responsible staff if urgent safety issues are identified.
• Works closely with other functional groups and departments including but n