Clinical Data Manager for NBCD A/S
- a Science-Driven Drug Development Organization
NBCD is an international drug development organization. We believe that personalized medicine and innovative study designs and execution are the key aspects in developing new drugs smarter, better and faster.
NBCD provides scientific and clinical trial services to the biotech and pharmaceutical industry in addition to developing our own drug candidates providing a unique mix of requirements from both the sponsor and CRO perspective.
NBCD was established in 2006 as a division of the Nordic Bioscience group established in 1992 and was formerly known as Nordic Bioscience Clinical Development. NBCD was spun out of the Nordic Bioscience group to form a new organization including the Sanos Clinics, which are dedicated clinical research centers. NBCD currently consists of 25 employees based in Herlev, Denmark and 5 Clinical Research Associates based throughout Europe and Asia. NBCD has recently partnered with a US company to establish a cross-Atlantic cooperation providing a true global reach together with our presence in Europe and Asia. We perform all aspects of clinical trials such as data management, regulatory affairs, pharmacovigilance, monitoring and trial management.
NBCD is a niche Clinical Research Organization (CRO) specialized in clinical drug development of innovative medicines primarily within rheumatology, dermatology and Alzheimer’s disease. We focus our efforts on innovative clinical trials in few therapeutic areas, where we can provide additional value, based on our research-legacy in connective tissue-diseases such as osteoarthritis and rheumatoid arthritis. NBCD is a small, but growing operation, which means we rely on, and leverage our agility and efficiency. Every team member has broad responsibilities and we strongly believe in empowerment and giving our employees freedom to operate and to innovate.
As a result of our continued growth, we are now looking for a Clinical Data Manager to join the team in Herlev outside Copenhagen, Denmark. The current team consist of 6 Data Managers and a Biostatistician in Denmark and 9 Data Managers, Programmers and Biostatisticians in our partner company in US.
Your job as Clinical Data Manager is highly varied and will amongst other responsibilities include the following:
NBCD has pioneered Risk-Based Monitoring and you will be a critical player in the continuous development of programmed central checks and metrics for monitoring the clinical data during collection.
Data Management collaborates closely with the Clinical Operations personnel in managing data quality, and you will be accountable for the delivery of regulatory-compliant clinical study data.
Take lead of the appointed clinical study and coordinate execution of data management activities in an international setting such as:
- creation, execution, and maintenance of data management processes from study start to database lock
- contribute to the eCRF design, validation, edit check specifications and programming
- establishment and life cycle management of data collection, external data reconciliation, querying, documenting data management activities
- creating eCRF user guidelines and train study staff
- generate various reports for the study team
NBCD collaborates with external partners, such as CROs, EDC Vendors, Central Imaging and Central Labs, where you will be an important player ensuring the data flow together with the rest of the Clinical Data Management team.
Additional duties will include ad-hoc analyses and reports of the clinical data for the clinical study teams, including relevant safety and quality driven reports.
Contribute to the team dynamics by having a special field of expertise e.g. statistical programming, power BI, randomization, or other area of your interest.
Desired skills and experience
- Preferably you have experience with clinical development in biotech, pharma or a CRO
- Preferably project management skills from previous experience
- Knowledge and experience with working in a GCP regulated environment will be considered a plus
- Experience with Electronic Data Capture (EDC) Systems and working knowledge of industry standards such as CDISC (CDASH and SDTM) will be considered a plus, but not a requirement.
- SAS programming, or programming in other languages, will be considered a plus
- Familiar with data management documentations and processes: DMP, DTS, Edit Checks Specifications, QC, UATs, DBL, will be considered a plus
- You must be a responsible person who can work independently and assume accountability of your delegated responsibilities
- You must be a creative thinker and be able to think outside the box. As a small organization, we rely on the combined creative intellect of the organization to solve issues rather than established procedures and check lists
- We expect you to be enthusiastic about innovative research and desire to learn new approaches and expand your core skill set
- You must have excellent communications skills and as most our communication is in English, you must be proficient in business English (spoken and written)
NBCD is offering
- An important role in a highly dynamic research-organization with world-wide reach
- An environment driven by science and good ideas, where you can truly make a difference and see your own ideas come to life
- Great opportunities for personal development
- The possibilities to broaden your efforts, being introduced to all clinical and non-clinical pre-market aspects of drug development in one place
- Voluntary contribution to our academic publication activities
- A flat, tight organization in which your successes will not go unnoticed
For further information please contact Clinical Operations Director; Christoffer von Sehested (email@example.com)
To apply, please send a letter of motivation and a CV to firstname.lastname@example.org