Clinical Trial Manager
Nordic Bioscience is an international drug development organization. We believe that personalized medicine, innovative study designs and execution are the key aspects in developing new drugs smarter, better and faster.
Nordic Bioscience Clinical Development (NBCD) was established in 2006 and is a division of the Nordic Bioscience group established in 1992. NBCD provides scientific and clinical trial services to the biotech and pharmaceutical industry in addition to developing own drug candidates. NBCD currently consists of 25 employees based in Herlev, Denmark in addition to 5 Clinical Research Associates based throughout Europe and Asia. We perform all aspects of clinical trials such as data management, regulatory affairs, pharmacovigilance, monitoring and trial management.
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. Nordic Bioscience is a small, but growing operation, which means we rely on 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.
We are now looking for a colleague to be a part of our Clinical Trial Management team in Herlev outside Copenhagen, Denmark
Your job as Clinical Trial Manager is highly varied and will amongst other responsibilities include the following:
- Responsibility for the execution of international Phase I-III trials according to ICH-GCP R2, applicable regulations and guidelines.
- Responsibility for the overall project management of assigned trial conduct from study start up to study closure, including oversight of the CRAs, both our own CRA’s and subcontracted CRA’s.
- Responsibility for the overall monitoring oversight, including risk-based monitor plan development, monitoring report review and mentoring of the CRA team. You may also co-monitor from time to time.
- Coordinating all relevant functions, strategic partners and other vendors/parties to develop and manage clinical project timelines.
- Contributing to protocol development and to feasibility assessments.
- Participation in issue management and risk mitigation for trials assigned to other Clinical Trial Managers.
- Conduct monitor training and coordinate investigator meetings.
- Light traveling expected (5-10 days per year)
Nordic Bioscience is a pioneer in Risk-Based Monitoring and you have the opportunity to be a critical player in the continuous development of our on-site and central monitoring methods.
Nordic Bioscience 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 Clinical Data Management team.
Desired skills and experience
- You have a degree in health sciences.
- Experience with GCP on an operational level is a requirement.
- Preferably you have 3+ years of clinical trial experience acting as either CTA, CRA, CTM or alike
- You possess good coordination skills, and are able keep track, delegate and prioritize tasks.
- You are a responsible person who can work independently and assume accountability of your delegated responsibilities.
- You are 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 have fluent business English (oral and written) and basic medical writing skills.
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: Nordic Bioscience A/S publishes around 50 peer-reviewed articles each year
- A flat, tight organization in which your successes will not go unnoticed
For further information please contact Clinical Operations Director; Sara Popik (email@example.com)
To apply, please send a letter of motivation and a CV to firstname.lastname@example.org no later than February 16th 2020