Senior Specialist Clinical Data Manager

Ascendis Pharma

Hellerup, Denmark

As our new Senior Specialist, Clinical Data Manager, you have a deep understanding of clinical data management, and through your work you will be recognized as an expert. Your way of collaborating with internal and external stakeholders, will help you lead the data management study team to succeed.

In this position you will be given broad responsibility tailored to our studies. You will oversee data management activities associated with the development, conduct, and management of assigned studies in endocrinology, and future therapeutic areas. You will provide oversight for across phase 1 to 4 trials serving as the lead data manager. You will work independently and collaboratively in a dynamic team environment.

You will work closely with our Data Management CRO, EDC Study Start-up Lead, External Data Specialists, Biometrics, and the Clinical Study Teams ensuring quality study deliverables are met. As the primary point of contact for internal stakeholders and Vendors, your will actively guide, advise, and steer, when it comes to clinical data management activities.

In this role you have a unique opportunity to be part of shaping the way we work within the Clinical Data Management organization. You bring with you a wealth of professional experience, you are passionate and have an eye for frameworks, processes, and best practices. We encourage you to think out of the box supporting the organization in doing an even better job, when preparing for future requirements. For the right candidate you will be given the mandate to participate or manage non-study initiatives and/or projects.

You will be supported by line management, who has in depth clinical data management experience, who can challenge, and spar as needed, and who will pave the way for you to succeed. Throughout the year you and your manager will meet to perform deep dive communication, where well-being, growth and collaboration are on the agenda.

Main areas of responsibility

Lead and provide oversight for the clinical data management activities from start-up to closure
Serve as the inter-department subject matter expert for CDM within the assigned clinical studies
Ensure the quality of clinical data meet standards for regulatory submissions
Manage, collaborate, and act as the primary point of contact with CRO partner to ensure quality deliverables within expected timelines
Serve as primary clinical data management contact within the clinical study team and ensure effective communication and collaboration
Strengthening the collaboration and cultivating strong relationships to the key stakeholders and vendors within the project
Provide technical and functional oversight of the day-to-day work within the assigned projects, as needed
Contribute/lead non-clinical initiatives, and assist with implementing the corporate strategic plan within the department
You may support the overall strategy and development of Clinical Data Management organization by participating in task force initiatives within the department.

Your Profile

A minimum of 10 years of clinical data management experience from pharma, biotech or CRO and a relevant academic degree in life sciences (e.g. data science, computer science, pharmacy, biology, statistics).

Furthermore, you have:

Hands-on data management experience from start-up to closure
Demonstrated oversight experience and leadership quality, and superior organizational and interpersonal skills
Knowledge of the current industry best practices, FDA, EMA and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations
Working knowledge of data standards (CDISC, CDASH, SDTM) in the clinical environment
Working knowledge of different EDC platforms and data collection tools such as ePRO
Prior experience supporting a BLA or NDA filing preferred
Experience mentoring more junior clinical data managers
Flexibility to have couple of hours of overlap of work hours with colleagues based in Palo Alto, California

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