HEAD OF CLINICAL PROJECT MANAGEMENT
BRIEF COMPANY PROFILE
Our client is a global, research-driven pharmaceutical company focusing on the development of prescription-only-medicines, and they are a global market-leader within their therapeutic area. The company headquarter is in Greater Copenhagen, Denmark with subsidiaries, production facilities and distributors worldwide.
Our client is looking to bring onboard a robust, people-first and high-caliber clinical operations executive to take on the leadership of the global clinical project management team at our client. The team consists of 11-15 Clinical Project Managers dedicated to the management, coordination and accomplishment of effective, successful and impactful global clinical studies.
The responsibilities of the Head of Clinical Project Management will incorporate overall responsibility for the leadership and coordination of global, comprehensive and groundbreaking clinical trials at our client. Moreover, the role will take a seat on the Global Clinical Development (GCD) Leadership Team – including Biometrics, Medical Writing, Clinical Trial Supply and Clinical Project Management - and will take part in setting the strategic direction of Global Clinical Development at our client.
Head of Clinical Project Management
Head of Global Clinical Development
Greater Copenhagen, Denmark
10-20 days per year
Responsibilities & Tasks:
· 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.
Key success criteria:
Ensuring decisive strategic leadership of the CPM area.
Ensuring that clinical projects are delivered on time, on budget and at appropriate quality.
Successfully driving a high-performance culture.
Establishing team followership and employee engagement.
Ensuring improved alignment and matching of expectations between internal and external stakeholders.
Ensuring appropriate prioritization of tasks within the team.
Achieving operational excellence in clinical trial management.
Successfully driving broad cross-functional stakeholder collaborations, alignment and communication.
Relevant education – minimum at M.Sc. level.
English – fluent (verbally and written).
Ideal experience and competencies:
Prior line management experience.
Excellent theoretical and practical knowledge of clinical project management/clinical trials – ideally from an international context.
Preferably core team experience.
+7 years of experience with clinical trial conduct – ideally including experience in writing protocols.
Strong people and project management and coordination capabilities, including sound followership flair and proficiency.
Evident stakeholder management and people skills.
Defines a clear vision. Looks beyond the immediate difficulties and focuses on the far-reaching consequences; sees things in a broad perspective; takes tendencies in the environment into account when planning and developing strategies.
Possesses a “people first” mindset. Actively trying to improve the skills and talent of the employees by giving positive and constructive feedback. Provides training and tasks with a view to challenging their skills and encourage development.
Makes sure employees/co-workers have a clear understanding of the direction of the tasks; takes action; organizes resources and direct others toward successful execution of the tasks; drives projects forward to reach pivotal objectives; makes things happen and follows through.
Inspiration and followership
Inspires others, creates followership and encourages the achievement of joint set goals by promoting a sense of purpose. Provides inspiration for a positive work attitude and prompts a strong wish to succeed in the team.
Communicates the central issues in a discussion in a clear, fluent and precise manner, and is able to keep the recipients' attention. Is attentive to the needs of others when speaking and produces written material which is clear, fluent, precise and easy to understand.
Collaborates and works well with others with the view to obtain the team's joint objectives. Shares information and supports others.
Planning and structure
Plans a focused course of action for oneself and peers and ensures an appropriate assignment of tasks for employees. Schedules an optimal use of the available resources and is able to plan ahead. Works systematically, organizes work and effort and is methodical while holding on to commenced tasks and projects.