MANAGER, CLINICAL DATA MANAGEMENT
BRIEF COMPANY PROFILE
Our client is a global, research-driven pharmaceutical company focusing on respiratory diseases. The company is headquartered in Greater Copenhagen, with subsidiaries, production facilities, and distributors worldwide. The company is predominately foundation owned and is growing double-digit.
The company has a long-standing commitment to act responsibly. For more than 10 years, it has been guided by the United Nations’ Global Compact principles, and in 2019, the company affirmed its commitment to these by becoming an active signatory of the UN Global Compact.
Our client is looking to bring onboard an experienced, driven, and high-caliber professional to lead the Clinical Data Management department as part of Biometrics and the extended Global Clinical Development team (GCD).
The Manager, Clinical Data Management (CDM), will have a focal role within the critical pathway inclinical research, leading to the generation of high-quality, reliable, and statistically sound data from clinical trials conducted at our client. The role will oversee the collection, integration and availability of data with the monitoring support of external vendors (CRO’s) while ensuring appropriate conduct, management and oversight of studies across all the clinical phases leading to robust conclusions drawn from research and well supported by data. This position will oversee a team of five Data Manager profiles and two External Data Consultant profiles directly. As part of the extended leadership team in GCD, the Manager, CDM, will provide valuable input to the overall Global Clinical Development agenda of our client.
The role offers strategic and executional involvement and responsibility – ranging from the continuous development and maintenance of data management systems and services, to the allocation of resources, and the delegation of team responsibilities.
Our client and their GCD team offer 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 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 specilization. Moreover, our client encourages a culture where there is always room for creativity and progressive thinking – with numerous employee ideas previously turning into successful company projects.
The ideal candidate for the role will not only bring relevant experience and competencies within clinical data management, but also possesses strong analytical aptitude and excellent communication, facilitation, and collaboration skills. Finally, the candidate is well- versed in handling multiple priorities within timelines, structured, quality-driven, and motivated by the opportunity to take on a key role within the Biometrics team.
Manager, Clinical Data Management
Head of Biometrics
Responsibilities & Tasks:
• Leading and controlling of the organization’s clinical data management and affiliated CRO activities for clinical trials.
• Driving and executing of biometric commitments for the organization.
• Allocating and delegating of data management resources to projects and tasks.
• Setting and executing high quality standards for clinical data management in clinical trials.
• Developing and maintaining of trial EDC systems standards (e.g. eCRF, eDiaries etc.), ensuring their completeness and consistency.
• Monitoring the compliance of ECD systems with current regulatory guidelines and reviewing their inspection- readiness.
• Ensuring the continuous maintenance and updating of key data management documentation, including SOPs, work instructions, and templates.
• Participating as part of the Biometrics management team and the extended GCD management team in leadership activities and team management related tasks.
• Reviewing the compliance of resources related to the data manager roles (e.g. training logs, personal development plans, job descriptions, and CVs) with the organization’s quality system.
• Supervising, reviewing, and coaching the work of employees within data management and supporting their development.
• Providing input regarding the performance and optimization
of Trial Protocols, CRFs and patient diaries, and Data Validation Plans.
• Overall project managing of data management related processes and electronic systems.
Key success criteria:
• Successful governance and delivery of high-quality data management activities with a focus on creating value for the product development process from start to finish.
• Contribution to a positive working environment that facilitates employee development and inspires high performance standards.
• Continuous development of high-quality data management systems and standards.
• Successful execution of data management projects and processes.
Relevant education - preferably at M.Sc.-level.
English - fluently in verbal and writing.
Ideal experience and competencies:
• 5+ years of clinical data management experience.
• Solid understanding of end-to-end clinical development
• Evident project management and coordination/oversight
capabilities, including sound followership flair and
proficiency – ideally within CDM.
• Currently or potential to become a first line manager.
• Thorough practical knowledge within relevant databases.
• Detailed understanding of ICH-GCP guidelines within the
area of clinical data management, and of other applicable legislation governing clinical drug testing and pharmaceutical drug production.
• Experience with eCRF and other EDC systems used in CDM.
• Some insight into validation of EDC systems used within
• Experienced and confident 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 of the team to succeed.
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.
Involvement, commitment and prioritization
Participates actively in considerations, decisions and actions, offers own opinion and makes own abilities available, while assessing the importance of decisions and actions with analysis of the most important issue first.
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.
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. Proactively anticipates and identifies complex issues and problems.
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 challenge their skills and encourage development.
Plans actions to secure optimal use of time and resources, compares achieved results to set objectives, follows up on delegated tasks and decisions.
Is concerned with reaching and maintaining quality; sets high standards for performance and execution – for oneself and for others.