Head of Data Management

Greater Copenhagen, Denmark


Our client is looking to bring on board an experienced, driven, and high-caliber professional to lead the Data Management department. This is a new position, and hence, the department is expanding. The Head of Data Management will be a part of the Biometrics Leadership Team (BLT). And have a focal role within the critical pathway in clinical development, leading to the generation of high-quality, reliable, and statistically sound data from clinical trials conducted for our client. The ideal candidate for the role will display strong leadership skills to inspire and guide the team toward high performance while fostering cross-departmental collaboration. The Head of Data Management will be responsible for ensuring that data management processes meet both operational and strategic goals, maintaining the highest standards of data quality and compliance. Furthermore, the role requires someone who can balance strategic vision with hands-on execution, navigating the fast-paced global environment of the company with adaptability, proactivity, and a collaborative leadership style, all to drive the success of clinical trials.

POSITION PROFILE
Position title:	Head of Data Management.

Reporting line:	Vice President, Biometrics.

Reporting to the position:	5 FTEs (Data Managers).

Location:	Greater Copenhagen.

Traveling:	Limited.

Responsibilities & Tasks:	Review clinical data and partake in strategy and allocating and delegating of data management resources to projects and tasks. Setting and executing high quality standards for clinical data management in clinical trials. Ensuring the continuous maintenance and updating of key data management documentation, including SOPs, work instructions, and templates. Ensuring thorough oversight of CRO activities. 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 and reviewing the work of employees within data management and supporting their development. Having hands-on responsibilities with data management activities. Overall project managing of data management related processes and electronic systems.

Key success criteria:	Developing and implementing a robust data management strategy that aligns with organizational and regulatory goals, while building and managing a cohesive, well-functioning team of data managers with clear roles, responsibilities, and professional development plans. 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. Successful execution of data management projects and processes. Establishing and maintaining strong relationships with CROs, ensuring high-quality data delivery and seamless collaboration across global clinical trials. Fostering strong collaboration between data management and other critical departments, ensuring smooth data handling from collection to analysis.

CANDIDATE PROFILE
Educational background:	Ideally a MSc. degree in relevant field.

Language:	Fluency in English (verbally and written)

Ideal experience:	Preferably 3+ years with line leadership or 5+ years of project leadership in data management. Preferably 7+ years of clinical data management experience in the pharmaceutical or biotech industry. Experience with outsourcing and oversight of clinical trial activities, including CROs. Solid understanding of end-to-end clinical development processes. Evident project management and coordination/oversight capabilities, including sound followership flair and proficiency. Thorough practical knowledge of relevant data systems. Proven track record of managing several projects and meeting deadlines, while adhering to industry quality and safety standards. Experience with eCRF and other EDC systems used in CDM. Some insight into validation of EDC systems used within CDM preferred. Experienced and confident IT-user.

Personal & leadership competencies:	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 directs others toward successful execution. Drives projects forward to reach pivotal objectives, makes things happen and follows through. Has the ability to navigate in an organization where priorities can change fast. Involvement, commitment and prioritization Participates actively in considerations, decisions and actions, offers his or her own opinion and makes own abilities available, while assessing the importance of decisions and actions with analysis of the most important issues first. Communication Communicates the central issues 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. Coaching/support Is 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 their development. Follow up  Plans actions to secure optimal use of time and resources, compares achieved results to set objectives, follows up on delegated tasks and decisions. Quality-minded Is concerned with reaching and maintaining quality; sets high standards for performance and execution – for oneself and for others.

Head of Data Management

POSITION PROFILE

CANDIDATE PROFILE

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