• Preparing trial plan and timelines within the frames of the project plan and communicating to the trial team and other relevant parties.

• Defining and delegating responsibilities, including affiliate trial team members and field CRA’s in agreement with the trial team.

• Setting trial related goals and monitoring progress against plan in agreement with the trial team.

• Reviewing and approving trial specific procedures and documentation.

• Performing any necessary adjustments to schedules, resource requirements, budgets and task assignments in agreement with line manager.

• Establishing and managing trial budget in collaboration with the Outsourcing Manager.

• Coordinating and driving the identification and selection of appropriate CRO’s in collaboration with the Outsourcing Manager.

• Acting as the link to CRO’s, central laboratory etc. if such are used and assuring that these are working in accordance to the agreed terms and conditions.

• Establishing clear communication lines and information within the trial- and clinical teams as well as with line management.

• Coordinating trial plans, resource needs, etc. with line management and ensuring that line management is informed about issues and actions that could have any impact on quality and/or timelines.

Trial set-up and initiation:

• Writing the clinical trial protocol.

• Developing and documenting trial specific procedures and documentation i.e. oversight plans, monitoring plans etc.

• Reviewing/participating in the preparation of CRF’s and other clinical documents.

• Coordinating and driving the clinical trial submission process to relevant regulatory authorities, ethics committees, data protection authorities etc. in accordance with local rules and regulations.

• Organizing CRA and/or investigator meetings.

• Providing trial specific information to the team at the start and during the trial.

• Coordinating and driving the identification and selection of appropriate sites.

• Approving trial sites based on the site selection reports and recommendations from affiliate/CRO’s.

• Ordering and coordinating the distribution of clinical trial supplies in collaboration with the Clinical Trial Supplies Manager.

• Overseeing the setup and maintenance of the in-house trial master file in collaboration with the Clinical Trial Assistant.

• Ensuring that field CRA’s are receiving trial specific monitoring information/training at the start and, if relevant, during the trial.

• Planning and ensuring of site selection and initiation visits.

• Ensuring that site selection/initiation reports are reviewed and, if necessarily, followed-up upon.

• Ensuring that investigator site files are established.

Trial conduct:

• Coordinating the writing and finalization of amendment(s) if applicable.

• Monitoring and ensuring trial progress, quality and consistency according to the trial oversight plans and the monitoring plan – potentially including:

• Performing review and oversight of patient recruitment.

• Ensuring planning and conduct of monitoring visits.

• Ensuring review of monitoring reports.

• Ensuring that trial and monitoring oversight visits are performed.

• Supporting the trial team (local affiliate/CRO staff) in the identification, tracking and resolution of issues and problems and, if necessary, in direct contact with investigators.

• Reviewing and giving input to the data validation plan.

• Reviewing coding of medication.

• Reviewing and giving input to the statistical analysis plan.

Trial completion:

• Monitoring the trial completion.

• Ensuring the planning and conduct of site close-out visits, including archiving of the investigator’s site file.

• Ensuring review of site close-out visit reports.

• Ensuring the completeness, quality and archiving of trial master file.

• Reviewing and giving input to the clinical report.

• Organizing result meetings for investigators if relevant.

• Preparing to participate in, and present at, internal results meetings in collaboration with the trial statistician.

Other work assignments:

• In case of audit/inspection from health authorities:

• Responding to any audit/inspection findings.

• Overseeing that corrective actions are implemented.

• Maintaining and updating trial information in the clinical trial overview.

• Reviewing and giving input to investigator’s brochure.

• If not a core development team (CTD) member, reviewing and giving input to the CDP.

• Participating in relevant cross-functional teams.

• Contributing to the development and maintenance of department procedures and guidelines.