Clinical Trial Assistant Specialist
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Hørsholm
ALK is on an ambitious journey to become the preferred allergy company globally and therefore we are looking for a new colleague to join us.
The position
This is an exciting opportunity to work within a fast paced, busy environment for a company who aspires to be world's leader within allergy treatment solutions. As a Clinical Trial Assistant Specialist (CTA specialist) you have to assist a team of dedicated Clinical Project Managers in ensuring the most effective and efficient conduct of clinical studies by providing administration and project tracking support.
Fields of responsibility
Your qualifications
The department/team
Today Clinical Project Management department consists of 14 passionate colleagues – 10 CPMs, 2 CTA, 1 SCM based in China and 1 COL based in US. As we are seeing an increase in the demand for administrative support in our ongoing and future trials, we now want to expand our team with another CTA.
As company we always try to develop our competences and processes to the meet the needs of the patients and all stakeholders, internally as well as externally. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with colleagues.
Clinical Project Management team work closely together with various functions who are important for the execution clinical trials: Regulatory, Data Managers, Medical writing, Statistician, Clinical Trial Supply etc.
The position is located at the ALK headquarter in Hørsholm and it is necessary to live in an area where it is possible to commute daily to the office.
Allergy Solutions For Life
More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing.
By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.
We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
If this sounds like a mission you also would like to be part of, we hope to receive your CV and application. We invite potential candidates for interview ongoingly, so please submit your application and CV as soon as possible, but no late than 31st of August.
Contact
For further information on the position please contact add contact person(s) incl. Kashifa Wichmann, Head of Clinical Project Management: +45 61911062 or Manager Christian Wolffbrandt: +45 61911026.
The position
This is an exciting opportunity to work within a fast paced, busy environment for a company who aspires to be world's leader within allergy treatment solutions. As a Clinical Trial Assistant Specialist (CTA specialist) you have to assist a team of dedicated Clinical Project Managers in ensuring the most effective and efficient conduct of clinical studies by providing administration and project tracking support.
Fields of responsibility
- Assist Clinical Project Managers with conduct of studies by supporting completion of required tasks to meet departmental and project goals
- To set up, organize and maintain clinical study documentation (e.g. Trial Master Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival Maintain Trial Master File throughout trial execution and ensure audit readiness
- Maintenance and distribution of trial documents internal/external
- To assist project teams with trial progress tracking by updating the Clinical Trial Management Systems
- Perform QC reviews and document tracking of trial documents
- Ensure timely submission to CTA.gov, and regular update on disclosure requirements
- Maintain insurance certificate and submission of FDA 1572 forms
- To assist in co-ordination of Investigator payments, if applicable
- Responsible for maintenance of various trial logs (e.g, vendors, COs, Q&A etc)
- Assisting Clinical Trial Teams with trial related tasks
- DOX assistance to GPCD colleagues
- Quality Documents distribution
- General archiving responsible
Your qualifications
- Broad experience with Trial Master Files
- Minimum of 5 years' experience in administrative assignments from clinical operations
- Experience with GCP
- Good organizational skills, ability to manage multiple tasks and attention to details
- Fluency in spoken as well as written English
- Experienced IT-user.
- Skilled in oral and written communication
The department/team
Today Clinical Project Management department consists of 14 passionate colleagues – 10 CPMs, 2 CTA, 1 SCM based in China and 1 COL based in US. As we are seeing an increase in the demand for administrative support in our ongoing and future trials, we now want to expand our team with another CTA.
As company we always try to develop our competences and processes to the meet the needs of the patients and all stakeholders, internally as well as externally. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with colleagues.
Clinical Project Management team work closely together with various functions who are important for the execution clinical trials: Regulatory, Data Managers, Medical writing, Statistician, Clinical Trial Supply etc.
The position is located at the ALK headquarter in Hørsholm and it is necessary to live in an area where it is possible to commute daily to the office.
Allergy Solutions For Life
More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing.
By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.
We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.
By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.
If this sounds like a mission you also would like to be part of, we hope to receive your CV and application. We invite potential candidates for interview ongoingly, so please submit your application and CV as soon as possible, but no late than 31st of August.
Contact
For further information on the position please contact add contact person(s) incl. Kashifa Wichmann, Head of Clinical Project Management: +45 61911062 or Manager Christian Wolffbrandt: +45 61911026.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Hørsholm.
Jobbet er oprettet på vores service den 5.6.2021, 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.
- Øvrige
- Hørsholm
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