Principal Clinical Data Management Specialist

Humlebæk, DK

Job Family: Research & Development

Country/Region: Denmark

Are you a visionary Clinical Data Management Specialist with a passion for driving innovation in healthcare through advanced medical device technology? Do you have extensive experience managing clinical trial data in accordance with regulatory and company requirements, and are ready to lead and redefine our approach to data management?

If so, Coloplast is looking for you to join our team at our headquarters in Humlebæk, Denmark.

The Position
As a Principal Clinical Data Management Specialist, you will play a crucial role in shaping the future of healthcare by leading our data management efforts. Your contributions will directly impact our ability to bring innovative medical devices to market, ultimately improving patient lives. You will be pivotal in leading our clinical data management efforts, working closely with the team to set direction and strategy in alignment with our vision. In a rapidly evolving industry, we need someone who can not only manage eCRF and ePRO solutions but also explore and integrate other dimensions of data management. This role entails both elements of daily operations and long-term vision/strategy, requiring someone who thrives in a position with an ever-shifting focus.

You will oversee the development and maintenance of clinical trial databases, but also build all databases for all studies you are involved in yourself as we work with end-to-end responsibility. You will perform advanced data review and quality control activities, and coordinate data management activities with study team members and external vendors. You will ensure adherence to clinical trial data management plans and ensure the timely and accurate completion of all data management activities. You will participate in study team meetings, provide updates on data management activities, and ensure compliance with regulatory requirements and industry standards.

More specifically, you will:

• Lead the management of clinical trial data from study start-up to database lock in accordance with Coloplast and regulatory requirements.
• Develop and maintain study-specific data management plans, including data validation and cleaning procedures.
• Ensure data quality and integrity through comprehensive review and query of clinical data, and resolution of data discrepancies.
• Collaborate with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, etc.
• Participate in the development and review of clinical study protocols, case report forms, and other study-related documents.
• Provide expert guidance and training on data management best practices to data management colleagues, study coordinators and clinical site staff, adopting a coaching style of interaction and emphasizing guidance over direct instruction.
• Innovate and redefine data management practices to encompass new dimensions beyond traditional eCRF and ePRO solutions.

Qualifications
To succeed in the role it is essential that you have extensive experience with data management in a clinical trial environment. You are highly organized and thrive in driving projects and motivating your surroundings.

Furthermore, you have:

• A bachelor's or master’s degree in life sciences, statistics, computer science, or a related field.
• At least 7 years of experience in clinical trial data management, preferably in the medical device or pharmaceutical industry, with a minimum of 5 years at the senior specialist level.
• Experience with clinical trial database management systems (e.g., Medidata Rave, Oracle Clinical, or similar).
• Strong knowledge of GCP (specifically ISO14155).
• Strong attention to detail and ability to work independently.
• Excellent organizational, communication, and interpersonal skills, capable of negotiating and influencing perspectives based on sound rationale.
• Fluency in English, both written and spoken.
• A visionary mindset with the ability to lead and innovate in a changing industry, translating strategies into actionable deliverables.
• Ability to balance daily operations with long-term strategic planning in a dynamic environment, providing valuable input for strategic decisions and contributing to long-term development planning.

The Department
At our HQ in Humlebæk, you will join 20 colleagues in the Clinical Operations team, part of the Payers & Evidence organization. We plan and execute clinical investigations within our Chronic Care and Wound Care portfolio. At Coloplast, our clinical agenda is growing and with it the need for clinical evidence. The data we generate is crucial for Coloplast's strategic goals, giving us a vital role in the future success of our organization. You will be working closely with other data management specialists as part of our dedicated team, ensuring comprehensive coverage and integration of data management efforts across all our clinical studies.

Interested?
If you would like to know more about the position, please contact Head of Data Management, Christian Balling at +45 4911 2371. Please note that Christian will be on vacation from July 13th – August 4th and will not be answering calls during this period.

We will take candidates into the recruitment process continuously, so do not hesitate to apply. This position will remain open until a suitable candidate has been found.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Visit us on Coloplast.com.

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