Boehringer Ingelheim

Key Responsibilities

• • Responsible 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
• • Responsible for medical input into CTP updates
• • 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
• • 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
• • Responsible 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
• • Responsible for 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
• • Takes medical responsibility for agile & adaptive risk based Clinical Quality Monitoring of critical data
• • Supports close to real time clinical data medical oversight by using advanced technologies and systems
• • Proactively addresses/communicates clinical quality issues in a collaborative environment
• • Contributes to the timely preparation of medically relevant core trial documents and timely milestones
• • Responsible for medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing
• • Responsible for “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 etc
• • Responsible 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
• • Responsible for medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
• • Contributes to the medical content of responses to questions from regulators and Ethic Committees/IRBs
• • Responsible for medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans
• • Responds to medical queries from Investigators, CROs and/or Sponsor team representatives and contributes to maintenance of trial FAQ log/list
• • Builds network with experts and active contribution to site engagement
• • Supports 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
• • Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff
• • Responsible for medical review of and contribution to the content of Trial Newsletters
• • Contributes to the scientific publication of trial data (If applicable)