CLINICAL PROJECT MANAGER
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 driven, high-caliber Clinical Project Manager to join the Global Clinical Project Management team – dedicated to the management, coordination and accomplishment of effective, successful and impactful global clinical studies.
The Clinical Project Manager will carry end-to-end responsibility for the leadership and coordination of global, comprehensive and groundbreaking global clinical trials at our client hereunder one of several novel and critical studies targeting children covering more than 100 sites in more than 10 countries. The role offers scientific, strategic and executional involvement and responsibility ranging from protocol writing to CTR review and direct authority discussion/involvement.
Our client and the Global Clinical Development team offers a high degree of responsibility in an open, trusting and supportive environment within a flat hierarchy with few silos and where feedback is communicated in a direct and open manner. Being a pioneering and highly ambitious company and displaying healthy top-line growth rates, our client is investing more than 20% of their annual turnover into R&D all contributing to our client being the global leader within their area of expertise. Moreover, our client encourages a culture where there is always room for creativity and progressive thinking and where numerous employee ideas previously has turned into successful company projects.
Clinical Project Manager
Global Head of Clinical Project Management
Greater Copenhagen, Denmark
10-20 days per year
Responsibilities & Tasks:
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.
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.
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.
Key success criteria:
- Obtaining joint collaboration targets with stakeholders.
- Establishing team followership and engagement towards study projects.
- Ensuring project plan alignment and progression, as well as project execution and finalization.
- Contributing to the establishment of a solid foundation for the success of colleagues and stakeholders.
Relevant education – minimum at M.Sc. level.
English – fluent (verbally and written).
Ideal experience and competencies:
- Thorough theoretical and practical knowledge of clinical project management/clinical trials – ideally from an international context.
- +3 years of experience with clinical trial conduct – ideally including experience in writing protocols.
- Strong project management and coordination capabilities, including sound followership flair and proficiency.
- Evident stakeholder management and people skills.
- Experienced IT-user.
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.
Direction and responsibility
Ensures that peers have a clear understanding of, and commitment to, direction and tasks. Organizes resources, takes action and direct others toward successful execution. Drives projects forward to reach pivotal objectives, makes things happen and follows through.
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 one self 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.
Is able to establish and maintain relations with people at all levels internally as well as externally and makes people feel at ease. Achieves agreement by dealing with disagreements and potential conflicts with diplomatic skills. Develops and maintains networks.