· Leading the Global Clinical Project Management organization.

· Part of the Global Clinical Development Leadership Team.

· Leading the team to deliver on time, in right quality and on budget.

· Setting the Clinical Project Management strategies in close collaboration with the GCD Leadership Team.

· Developing and maintaining a high level of competences and motivation within the team.

· Taking overall and decisive leadership of designated clinical projects from strategy to execution.

· Guiding the team in ensuring the preparation of trial plans and timelines within the frames of the project plans.

· Guiding the team in ensuring effective communication to their trial teams and other relevant parties.

· Following up on set performance and trial related goals of the team members – hereunder ensuring team members’ effective   monitoring of progress against plan in agreement with the trial team.

· Reviewing and approving trial specific procedures and documentation.

· Guiding the team in ensuring the performance of any necessary adjustments to schedules, resource requirements, budgets and task   assignments.

· Guiding the team in ensuring effective coordination,   identification and selection of appropriate CRO’s in collaboration with the Outsourcing Manager and the designated team members.

· Ensuring overall clear communication lines and information within the trial- and clinical projects.

· Guiding the team in ensuring effective coordination of trial plans, resource needs, etc. and staying abreast about issues and actions that could have any impact on quality and/or   timelines.

Trial set-up and initiation –   ensuring team is capable of:

· 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 – ensuring team is   capable of:

· 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:

o Performing review and oversight of patient recruitment.

o Ensuring planning and conduct of monitoring visits.

o Ensuring review of monitoring reports.

o Ensuring that trial and monitoring oversight visits are performed.

· Supporting the trial team (local ALK/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 – ensuring team   is capable of:

· 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:

o Ensuring response to any audit/inspection findings.

o Overseeing that corrective actions are implemented.

· Ensuring the maintenance and updating of trial information in the clinical trial overview.

· Ensuring appropriate review and input to investigator’s   brochure.

· Participating in relevant cross-functional teams.

· Ensuring the development and maintenance of department procedures and guidelines.