Senior Clinical Disclosure Professional
- Research & Development
- Denmark - Søborg
Novo Nordisk recently announced our commitment to a high level of transparency of our global clinical research activities by volunteering to make Clinical Study Reports public via NovoNordisk-Trials.com for products marketed in EU and US. Consequently, a substantial amount of Clinical Study Reports are to be made ready for disclosure and uploaded to the external web-site. This is a new challenge and to assist us in making this happen, and to take part in other activities to ensure transparency of Novo Nordisk global clinical research activities, we are seeking two new colleagues for the Global Clinical Registry department.
You will be working with colleagues worldwide, be part of establishing work processes, and planning and overseeing the conduct of the activities. You have a university degree, MSc within natural science, and have several years of experience working with clinical research either as e.g. a medical writer, or clinical trials manager.
About the department
Global Clinical Registry is part of Novo Nordisk Clinical Reporting area, and currently employs 6 people. In total the Clinical Reporting group consists of more than 50 people working with reporting and publishing of clinical reports. The group consist of different nationalities as well as professional backgrounds.
The availability of the information on clinical research to the public is governed by legal requirements. It is a challenge for the department to be up-to-date with the progress of the portfolio of clinical research activities in order to meet the legal requirements. Information on the clinical research in terms of study initiation, completion, results availability and scientific publications is captured via the Clinical Trial Management System (CTMS), and a disclosure IT system, PURE, is used to keep track of the deadlines.
Global Clinical Registry oversees and performs registration of our worldwide clinical activities. We manage timely release of results information to clinicaltrials.com, to NovoNordisk-trials.com, and to the EU Clinical Trials Register which, from next year, also will hold results of clinical trials. It is also our responsibility to keep aligned with national requirements for clinical trial registries in other countries. Finally we cover the maintenance of our clinical disclosure IT system and NovoNordisk-trials.com.
As part of Clinical Reporting, the job brings the option of being involved in other activities. Flexibility in relation to the growing Novo Nordisk portfolio of drug development projects calls for allocation of the resources where they are needed the most.
The Job
You will be working across the entire Novo Nordisk portfolio of clinical research activities, and in close collaboration with colleagues such as clinicians, statisticians, regulatory affairs professionals and trial managers from Novo Nordisk headquarters and international affiliates.
The purpose of your job will be to ensure disclosure of clinical research reports to the public in accordance with Novo Nordisk new disclosure code of conduct and to engage in other of the departments’ disclosure activities.
New challenges are ahead of us and the purpose of the 2 new jobs is to engage in shaping new work processes, planning activities, ensuring the job is done timely and to the right level of quality, and engage in use of and update/introduction of the use of IT systems.
One of the positions will be focused towards project management of report disclosure activities, whereas the other will be focused towards the use of IT tools.
Qualifications
Our preferred candidates have a university degree within natural sciences (MD, M.Sc., M.Sc.Pharm. or equivalent). Skills within statistics, scientific research methods, and experience in writing scientific reports, publications for scientific journals or similar will be considered a benefit. You must master written and spoken English at a professional level. Furthermore both jobs require planning and coordination of activities, and some level of project management skills is desirable.
You are a strong team player who adapts easily to a changing environment who works with at times tight deadlines. You are thorough, structured and conscientious.
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Contact
For further information please contact Merete Jørgensen +45 3079 1728.
Deadline
16 December 2013
- Research & Development
- Denmark - Søborg
Novo Nordisk recently announced our commitment to a high level of transparency of our global clinical research activities by volunteering to make Clinical Study Reports public via NovoNordisk-Trials.com for products marketed in EU and US. Consequently, a substantial amount of Clinical Study Reports are to be made ready for disclosure and uploaded to the external web-site. This is a new challenge and to assist us in making this happen, and to take part in other activities to ensure transparency of Novo Nordisk global clinical research activities, we are seeking two new colleagues for the Global Clinical Registry department.
You will be working with colleagues worldwide, be part of establishing work processes, and planning and overseeing the conduct of the activities. You have a university degree, MSc within natural science, and have several years of experience working with clinical research either as e.g. a medical writer, or clinical trials manager.
About the department
Global Clinical Registry is part of Novo Nordisk Clinical Reporting area, and currently employs 6 people. In total the Clinical Reporting group consists of more than 50 people working with reporting and publishing of clinical reports. The group consist of different nationalities as well as professional backgrounds.
The availability of the information on clinical research to the public is governed by legal requirements. It is a challenge for the department to be up-to-date with the progress of the portfolio of clinical research activities in order to meet the legal requirements. Information on the clinical research in terms of study initiation, completion, results availability and scientific publications is captured via the Clinical Trial Management System (CTMS), and a disclosure IT system, PURE, is used to keep track of the deadlines.
Global Clinical Registry oversees and performs registration of our worldwide clinical activities. We manage timely release of results information to clinicaltrials.com, to NovoNordisk-trials.com, and to the EU Clinical Trials Register which, from next year, also will hold results of clinical trials. It is also our responsibility to keep aligned with national requirements for clinical trial registries in other countries. Finally we cover the maintenance of our clinical disclosure IT system and NovoNordisk-trials.com.
As part of Clinical Reporting, the job brings the option of being involved in other activities. Flexibility in relation to the growing Novo Nordisk portfolio of drug development projects calls for allocation of the resources where they are needed the most.
The Job
You will be working across the entire Novo Nordisk portfolio of clinical research activities, and in close collaboration with colleagues such as clinicians, statisticians, regulatory affairs professionals and trial managers from Novo Nordisk headquarters and international affiliates.
The purpose of your job will be to ensure disclosure of clinical research reports to the public in accordance with Novo Nordisk new disclosure code of conduct and to engage in other of the departments’ disclosure activities.
New challenges are ahead of us and the purpose of the 2 new jobs is to engage in shaping new work processes, planning activities, ensuring the job is done timely and to the right level of quality, and engage in use of and update/introduction of the use of IT systems.
One of the positions will be focused towards project management of report disclosure activities, whereas the other will be focused towards the use of IT tools.
Qualifications
Our preferred candidates have a university degree within natural sciences (MD, M.Sc., M.Sc.Pharm. or equivalent). Skills within statistics, scientific research methods, and experience in writing scientific reports, publications for scientific journals or similar will be considered a benefit. You must master written and spoken English at a professional level. Furthermore both jobs require planning and coordination of activities, and some level of project management skills is desirable.
You are a strong team player who adapts easily to a changing environment who works with at times tight deadlines. You are thorough, structured and conscientious.
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.
Contact
For further information please contact Merete Jørgensen +45 3079 1728.
Deadline
16 December 2013