Associate Director/Director of Clinical Data Management Operation (DK)

Associate Director/Director of Clinical Data Management Operation (DK)

Ascendis Pharma

Hellerup, Denmark

As our new Associate Director/Director of Clinical Data Management Operation (DK), 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 Copenhagen based data management team to success.

As a leader in the Clinical Data Management (CDM), Endocrinology group and subject matter expert for Clinical Data Managers, you will oversee data management activities associated with clinical drug development for all clinical trials in Ascendis’ rare endocrinology portfolio. Furthermore, the duties of this role include CDM oversight including strategic resourcing, timeline planning, leading organizational change, process improvement and participation in cross-functional initiatives.

The responsibilities of this position will also include partnering and collaborating with other functional groups and external vendors to ensure timelines and quality of project deliverables, creating, updating and maintaining SOPs to ensure the validity of clinical trial databases, and being familiar with the implementation of Good Clinical Practice (GCP) as it applies to CDM. The individual will also provide leadership to the CDM group by developing and empowering staff; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.

As Associate Director/Director of CDM - Operation (DK) you will also play a key member in the Clinical Data Management, Endocrinology Management group as well as work closely together with the Director of CDM - Operation (US), the Program Director and the Director of System, Standards and processes.

Main areas of responsibility:

• Lead daily operations of the DK Clinical Data Management (CDM) team and act as the subject matter expert for assigned trials;
• Ensure high-quality clinical trial data for decision-making, regulatory approval, and market acceptance;
• Oversee CDM process improvements, vendor management, system evaluation, and data integration;
• Mentor and guide data managers while ensuring compliance with protocols, SOPs, and regulatory standards;
• Provide strategic and operational leadership, overseeing daily tasks, timelines, and quality control;
• Manage vendor relationships, mitigate risks, and support regulatory submissions and Development Operations initiatives.

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:

• Experience with line management and/or serving as a mentor or technical lead;
• 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 (e.g. Veeva CDMS) and data collection tools such as ePRO;
• Prior experience supporting a BLA or NDA filing preferred;
• Flexibility to have couple of hours of overlap of work hours with colleagues based in Palo Alto, California and US East Coast.

Also, you are proficient in English at a professional level, both written and spoken.

As a person, you are a strong team player, proactive in nature and have a can-do attitude. As we are taking new steps towards developing best-in-class therapeutics for patients with rare diseases we are looking for people who possess an entrepreneurial mindset who can handle ambiguity, analyze, and create clarity and desires to be part of an organization where everything isn’t set in stone. We rely on you to help us shape the cement and be part of building the biometrics team in the Copenhagen office. The person we are looking for thrives in a dynamic environment, short lines of communication and an open and informal working atmosphere.

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