Clinical Data Management Director
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Holbæk
Do you have a passion for clinical data management and are you motivated by a broad responsibility across our clinical trials. Are you experienced in leading data management activities in an outsourced setup from start-up to closure of clinical trials? If so, join Pharmacosmos and make a meaningful impact on patient care.
You will be joining our dedicated team of professionals in Clinical Development at the Headquater, located in Holbæk.
Due to the growth and success of Pharmacosmos this is a newly established role in Clinical Development. As Clinical Data Management Director, you will be responsible for overseeing data management activities across our portfolio of clinical studies. You will be responsible for proactively securing reliable, timely, and high-quality clinical trial data for Pharmacosmos trials by leading and executing end-to-end oversight for clinical data management activities across phase 1 to 4 for both human clinical trials and veterinary studies.
You will work closely with CROs and internal stakeholders in the setup of our trials, and provide CRO oversight during study conduct, including oversight of data quality and data cleaning, as well as detection of data trends. You will serve as the main contact for all data management activities for the clinical trial teams. You will provide strategic data management expertise to ensure high-quality data deliverables are achieved within timelines and budget. You have a passion for developing processes and systems related to clinical data management.
You hold a relevant academic degree – typically a degree in life sciences (e.g., biology, data science, computer science, statistics), and at least 10 years of relevant clinical data management experience or equivalent combination of academic degree and relevant job experience.
Furthermore, you have:
As a person, you are a strong team player, proactive in nature and have a high-quality mindset. You are determined to do and be your best and take pride in enabling the best work of others on the team. The person we are looking for thrives in a dynamic environment, short lines of communication and an open and informal working atmosphere.
Genux Executive is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Tina Lorenzen, on [email protected].
Your CV (in English) should be submitted to [email protected] as soon as possible and no later than September 11, 2023.
About the team
You will be joining our dedicated team of professionals in Clinical Development at the Headquater, located in Holbæk.
About the job
Due to the growth and success of Pharmacosmos this is a newly established role in Clinical Development. As Clinical Data Management Director, you will be responsible for overseeing data management activities across our portfolio of clinical studies. You will be responsible for proactively securing reliable, timely, and high-quality clinical trial data for Pharmacosmos trials by leading and executing end-to-end oversight for clinical data management activities across phase 1 to 4 for both human clinical trials and veterinary studies.
You will work closely with CROs and internal stakeholders in the setup of our trials, and provide CRO oversight during study conduct, including oversight of data quality and data cleaning, as well as detection of data trends. You will serve as the main contact for all data management activities for the clinical trial teams. You will provide strategic data management expertise to ensure high-quality data deliverables are achieved within timelines and budget. You have a passion for developing processes and systems related to clinical data management.
About you
You hold a relevant academic degree – typically a degree in life sciences (e.g., biology, data science, computer science, statistics), and at least 10 years of relevant clinical data management experience or equivalent combination of academic degree and relevant job experience.
Furthermore, you have:
- Strong knowledge of data management processes, standards, and regulations, and extensive hands-on data management experience from start-up to closure.
- Experience conducting and securing vendor oversight of data management for outsourced clinical trials.
- Knowledge of the current industry best practices, FDA, EMA, ICH-GCP, 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 other data collection tools such as ePRO and IWRS.
- Demonstrated ability to lead and manage data management activities for multiple clinical trials simultaneously.
- Flexibility since we are working with CROs worldwide.
- Strong ability to work independently, and comfortable taking responsibility
- Strong analytical and problem-solving skills.
- Effective communication and interpersonal skills and excellence 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 high-quality mindset. You are determined to do and be your best and take pride in enabling the best work of others on the team. The person we are looking for thrives in a dynamic environment, short lines of communication and an open and informal working atmosphere.
We offer
- An opportunity to join a dedicated clinical team with an open and friendly atmosphere.
- An independent function in a global setting.
- Inspiring and flexible working environment.
- An exciting role where you can develop your personal and professional competencies and contribute to Pharmacosmos' continued global growth.
- To ensure a balanced approach to the office, you will have the opportunity to work from home as agreed with your manager.
Additional information
Genux Executive is responsible for the recruitment process on behalf of Pharmacosmos A/S. Further information about the position can be obtained by contacting Recruitment Partner Tina Lorenzen, on [email protected].
Your CV (in English) should be submitted to [email protected] as soon as possible and no later than September 11, 2023.
Information og data
Denne ledige stilling har jobtypen "Data Manager", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i Holbæk.
Jobbet er oprettet på vores service den 28.8.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Data Manager
- Holbæk
- Mandag den 11. september 2023
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