Regulatory Affairs Officer, Munich, Germany

New established position as Regulatory Affairs Officer


New established position as Regulatory Affairs Officer

KLIFO GmbH is currently expanding its service offering in Germany by introducing an end-to-end drug development consultancy including a Regulatory Affairs Solutions department, similar to what the company has in Denmark.

The Regulatory Affairs Officer is responsible for collaboration with clients as well as competent authorities and the execution of projects according to the clients´s expectations.

The position requires a hands-on approach to servicing existing and new clients in the DACH region.

You will report to our Senior Director New Business DACH in Munich.

The position as Regulatory Affairs Officer may involve:

  • Project management
  • Liaison with competent authorities
  • General regulatory affairs work
  • Management of regulatory procedures
  • Preparation and submission of CTA as well as other regulatory documents, e.g. (non-exhaustive list): Briefing packages, IMPD, IND, MAA/NDA, Variations, Renewals, changes in the clinical trials, notification at the end of the clinical trials
  • Writing and reviewing SOPs
  • Cross-functional collaboration within KLIFO
  • Participation in and support to projects in other KLIFO departments according to the training, experience and skills of the RA Officer

Qualifications:

  • M.Sc. in the life sciences field or RA specific diploma/master and a minimum 2 years of experience within Regulatory Affairs in the area of clinical research in the pharmaceutical industry/CRO
  • Excellent knowledge of regulatory requirements and ICH-GCP
  • Excellent communication skills (written and verbal)
  • Fluent in German and English
  • Experienced user of Microsoft Office Package and good understanding of databases
  • Strong organizational skills with attention to details
  • Willingness to work from client sites, when required

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player and possesses excellent planning skills.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Join a team of experienced colleagues where you use and elaborate your skills and competences
  • Work in an interactive, flexible and positive working environment with a high level of transparency
  • Opportunity to join an European-based organisation with global reach and a strong and dedicated plan for growth

Location:

KLIFO has offices in Denmark, Germany, Sweden and The Netherlands. This position is located at our office at Heimeranstrasse 35 in Munich.

Contact:

For more information, please contact Senior Director Christine Tiesler at +49 89 895286-31

Applications including salary expectations should be sent to: moc.ofilk@boj marked “Regulatory Affairs Officer, Munich”.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


Experienced Clinical Research Associate

Experienced Clinical Research Associate Clinical Trials in Germany


Experienced Clinical Research Associate Clinical Trials in Germany

KLIFO  wants to appoint an experienced Clinical Research   Associate   into  a  dynamic   and  experienced team  within Clinical  Operations  Solutions  in  Germany. The   people   we   want   to   engage   like   to   work   in   a consulting environment and have a positive, proactive, flexible,  self-driven  and  self-confident  personality.  We can  offer  a  highly flexible,  free  and  trustful  working climate with exciting customers and projects among competent  colleagues  where  your  knowledge, experience and contribution are valuable and highly appreciated

The position as Clinical Research Associate (CRA):

The CRA has considerable knowledge and is responsible as primary contact for investigational sites, conduct of monitoring activities and for assistance of the Project Manager:

  • Continuous relationship with the Principal Investigators and trial staff to assure the success of the trial in terms of enrolment and quality
  • Visiting investigator and investigational site before a specific trial: pre-trial/site assessment visits
  • Performing initiation, routine monitoring and close-out visits
  • Elaboration of trial specific procedures
  • Participation in the preparation of trial documents for submissions to Competent Authorities and Ethics Committees/Institutional Review Boards
  • Support to data management activities
  • Assist in ensuring site compliance with protocol and trial objectives
  • Work in the clinical trial team, reporting to project manager for trial related deliverables
  • Translation/review of essential documents
  • Liaison between sponsors, investigators and vendors
  • Project management

Qualifications:

  • Minimum 2 years of experience as CRA within industry/CRO/BioTech
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Excellent verbal and communication skills
  • Native speaker of German of comparable level (e.g. able to translate patient documents or ICFs into German, able to talk and email in German with site personnel)
  • B.Sc. in the life sciences field or CRA specific diploma
  • Good computer skills, ability to develop and maintain excel spreadsheets, handling of access database and to elaborate PowerPoint presentations.
  • Strong organizational and planning skills
  • Accurate and precise with attention to details
  • Ability to motivate

In addition the ideal candidate is a dedicated and collaborative team player, and fluent, spoken and written, in English.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use – and elaborate – your competences and experience
  • Work in an interactive, flexible and positive working environment

Location:

This position is located at our office in Munich.

Contact:

For more information, please contact Sibylle Gaupels, Team Manager CRAs, Clinical Operations Solutions at +49 160 94 14 39 35.

Applications should be sent to moc.ofilk@boj marked “CRA, Munich”.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


Project Manager - Clinical Operations Solutions, Glostrup, Denmark

Project Manager


KLIFO is looking for a talented and committed Project Manager (PM) based in Denmark

KLIFO is expanding our office in Sweden and wants to engage Project Managers into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality.

We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Project Manager:

The Project Manager (PM) is responsible for the delivery of an agreed trial as defined in the trial outline/protocol, to the agreed quality, budget and timelines:

  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials
  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
  • Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls
  • Development of project plans for the conduct of the clinical trial. 
  • Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and to COS management team

The qualifications of the Project Manager:

  • BSc/MSc in the life sciences field and a minimum of 3-4 years in a similar position in the pharmaceutical industry/BioTech/CRO
  • Experience within clinical trial management, preferably within phase 1
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Ability to translate client’s needs into a solid project plan
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than in English)
  • Microsoft Office Skills

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia) 
  • Build international client relations 
  • Use and elaborate your competences and experience
  • Work in an interactive, flexible and positive working environment 

Location:

KLIFO has offices Denmark, Germany, Sweden and The Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Jennie Wilborgsson, Clinical Research Director, KLIFO A/S at +45 9363 8820

Applications should be sent to: 

moc.ofilk@boj marked Project Manager. KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline:
23 November 2020 (although applications are reviewed on an ongoing basis)

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Regulatory Affairs Officer, Munich, Germany

New established position as Regulatory Affairs Officer


New established position as Regulatory Affairs Officer

KLIFO GmbH is currently expanding its service offering in Germany by introducing an end-to-end drug development consultancy including a Regulatory Affairs Solutions department, similar to what the company has in Denmark.

The Regulatory Affairs Officer is responsible for collaboration with clients as well as competent authorities and the execution of projects according to the clients´s expectations.

The position requires a hands-on approach to servicing existing and new clients in the DACH region.

You will report to our Senior Director New Business DACH in Munich with a dotted line to our VP Regulatory Affairs in Denmark.

The position as Regulatory Affairs Officer may involve:

  • Project management
  • Liaison with competent authorities
  • General regulatory affairs work
  • Management of regulatory procedures
  • Preparation and submission of CTA as well as other regulatory documents, e.g. (non-exhaustive list): Briefing packages, IMPD, IND, MAA/NDA, Variations, Renewals, changes in the clinical trials, notification at the end of the clinical trials
  • Writing and reviewing SOPs
  • Cross-functional collaboration within KLIFO
  • Participation in and support to projects in other KLIFO departments according to the training, experience and skills of the RA Officer

Qualifications:

  • Sc. in the life sciences field or RA specific diploma/master and a minimum 2 years of experience within Regulatory Affairs in the area of clinical research in the pharmaceutical industry/CRO
  • Excellent knowledge of regulatory requirements and ICH-GCP
  • Excellent communication skills (written and verbal)
  • Experienced user of Microsoft Office Package and good understanding of databases
  • Strong organizational skills with attention to details
  • Willingness to work from client sites, when required

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player, possesses excellent planning skills and is fluent, spoken and written, in English and Danish.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Join a team of experienced colleagues where you use and elaborate your skills and competences
  • Work in an interactive, flexible and positive working environment with a high level of transparency
  • Opportunity to join an European-based organisation with global reach and a strong and dedicated plan for growth

Location:

KLIFO has offices in Denmark, Germany and Sweden. This position is located at our office at Heimeranstrasse 35 in Munich.

Contact:

For more information, please contact Senior Director Christine Tiesler at +49 89 895286-31

Applications including salary expectations should be sent to: moc.ofilk@boj marked “Regulatory Affairs Officer, Munich”.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


Medical Writer - for our Munich office

Medical Writer


KLIFO is looking for a talented and committed Medical Writer

KLIFO A/S is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling. KLIFO A/S has offices in Denmark, Sweden and Germany.

KLIFO now wants to appoint a talented and commited Medical Writer into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Medical Writer:
The MW is responsible for creation of medical and scientific documents and the factual and formally correct display of scientific results and findings within clinical trials and non-interventional studies according to the FDA/EMA and ICH guidelines, i.e.:

  • Writing of study protocols
  • Generation of clinical study reports
  • Generation of IBs and other documents related to the conduct of clinical trials, non-interventional studies according to the FDA/EMA and ICH guidelines
  • Generation of patient facing documents, e.g. patient information
  • Support the project team in preparation and compilation of narrative safety reports
  • Advise the project team in preparation of study documents
  • Prepare and give presentations when required
  • Ad hoc tasks within the department and KLIFO
  • Develop and review of SOPs to support department activities

The qualifications of the Medical Writer:
The Medical Writer should possess the following qualifications:

  • MSc in the life sciences field or related discipline, preferable with a PhD and a minimum of 3 years in a similar position in the pharmaceutical industry/CRO
  • Experience in Medical Writing, particularly in the creation of Clinical Study Protocols and Clinical Study Reports conforming to ICH-GCP
  • Good statistical understanding in the area of descriptive statistics
  • Ability to reproduce scientific data and complex issues accurately and in an understandable form
  • Knowledge of SOPs, GCP guidelines, regulatory requirements, medical terminology and clinical trial processes
  • Excellent Microsoft Office skills
  • Excellent communication skills (written and verbal) in English as well as in German

In addition to the above-mentioned qualifications, the ideal candidate is action orientated, possesses good analytical skills, is able to make decisions and has strong planning and task management skills.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use – and elaborate – your competences and experience
  • Work in an interactive, flexible and positive working environment

Contact:
For more information, please contact Doris Wiegel, Managing Director KLIFO GmbH at +49 89 895286-0.

Applications should be sent to:  moc.ofilk@boj marked “Medical Writer”

Applications will be assessed on an ongoing basis.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


Project Manager - Clinical Trials, Munich, Germany

Project Manager, Clinical Trials – Munich, Germany


KLIFO is looking for a talented and committed Project Manager Clinical Trials in Germany

KLIFO A/S is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling. KLIFO A/S has offices in Denmark, Sweden, Germany and the Netherlands

The German office (KLIFO GmbH) now wants to appoint a Project Manager for the conduct of clinical trials into a dynamic and experienced team within Clinical Operations Solutions in its Munich office. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and selfconfident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

The position as Project Manager (PM):

The Project Manager is overall responsible for managing the clinical trials, i.e.:

  • Main point of contact to sponsor representative
  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials
  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Liaison with clinical trial team members regarding trial design and protocol preparation and ensure the production of the final trial protocol
  • Lead the Risk Based Quality Management (RBQM) process including risk assessment and risk controls
  • Development of project plans for the conduct of the clinical trial.
  • Communicate timelines, identify milestones, handle trial budget and report progress for the clinical trials to sponsor and to COS management team
  • Ad-hoc tasks within the department and KLIFO
  • Develop and review of SOPs to support department activities
  • Monitoring of selected sites, e.g. KoL
  • When outsourced to a client and acting as Sponsor PM:
    • Carry out the CRO selection process and review CRO contracts with respects to tasks, budget and timelines
    • Lead the Sponsor oversight activities and ensure clear responsibility split between sponsor and CRO

The qualifications of the Project Manager:

The Project Manager should possess the following qualifications:

  • MSc in the life sciences field or a medical/veterinary degree and at least 5-6 years overall experience out of which 2 years in project management in the pharmaceutical industry/BioTech/CRO
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Demonstrated project management skills including the ability to plan and conduct an international, multicountry clinical trial and operate within plan and budget
  • Willingness to travel
  • Excellent verbal and written communication skills
  • Computer skills, ability to develop and maintain excel spreadsheets and to generate PowerPoint presentations.
  • Fluent in English and in German (spoken and written)

The ideal candidate is a dedicated team player, able to make decisions and has strong planning and task management skills.

We offer

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia)
  • Build international client relations
  • Use – and elaborate – your competences and experience
  • Work in an interactive, flexible and positive working environment

Location:

This position is office-based at our office in Munich.

Contact:

For more information, please contact Sibylle Gaupels, Team Manager Project Management & Data Management, KLIFO GmbH at +49 160 94143935 

Applications should be sent to:

moc.ofilk@boj marked “Project Manager Clinical Trials, Munich”. Wir freuen uns auch über Bewerbungen auf Deutsch

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Further information about KLIFO can be found at www.klifo.com

View job post as a PDF.


Clinical Trial Assistant (CTA) - Clinical Operations Solutions, Glostrup, Denmark

Clinical Trial Assistant (CTA)


KLIFO is looking for a Clinical Trial Assistant (CTA) for our Glostrup office

KLIFO is expanding and wants to engage a Clinical Trial Assistant into a dynamic and experienced team within Clinical Operations Solutions. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated.

KLIFO is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Operations Solutions, Pharmacovigilance Solutions, Clinical Trial Supply Solutions, Regulatory Affairs Solutions, QA Solutions, CMC Development Solutions and Drug Development Counselling. KLIFO has offices in Denmark, Sweden and Germany.

The position as Clinical Trial Assistant:

The CTA is seen as a document manager and responsible for setting up and maintaining the Trial Master File as well as filing plans. Further, the CTA is responsible for providing comprehensive support to the clinical team for the set up and administration of projects conducted by KLIFO, i.e.:

  • Preparation and updating of the Trial Master Files and Investigators Files
  • Supporting the Project Manager and the Clinical Research Associates in the management of clinical trials
  • Management of shipment/retrieval of study materials
  • Supporting the Project Manager in meeting organisation

The qualifications of the Clinical Trial Assistant:

The Clinical Trial Assistant should possess the following qualifications:

  • A minimum of 2 years in a similar position in the pharmaceutical industry/CRO. Candidates within business administration or Librarian, or equivalent will also be considered
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Good communication skills (written and verbal)
  • Computer skills, ability to use the Microsoft Office Package (word, excel, etc)

In addition to the above-mentioned qualifications the ideal candidate is a service minded and collaborative team player that possesses planning skills, attention to detail and is fluent, spoken and written, in English and in a Scandinavian language.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech,investigators/academia)
  • Build international client relations
  • Use – and elaborate – your competences and experience
  • Work in an interactive, flexible and positive working environment

As KLIFO is a smaller service provider, you will experience a high level of transparency, influence and a good possibility for individual planning. KLIFO is located in Smedeland 36, 2600 Glostrup. Further information about KLIFO can be found at www.klifo.com

Contact:

For more information, please contact Tina Hjorth, Senior Clinical Research Director, COS, at 44 222 934

Applications should be sent to: moc.ofilk@boj marked CTA.

Deadline: 12 June 2020.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

View job post as a PDF.


Clinical Supply Logistic Coordinator

Clinical Supply Logistic Coordinator


KLIFO søger en dygtig og engageret medarbejder til vores Supply afdeling

KLIFO Supply udvider og søger derfor en Clinical Supply Logistic Coordinator til Supply afdelingen bestående af 35 erfarne medarbejdere. Afdelingen håndterer opgaver i forbindelse med koordinering, pakning, opbevaring og distribution af medicin til kliniske studier i ind- og udland. Vi ønsker at tiltrække medarbejdere der er serviceminded og fleksible og interesserer sig for at arbejde i en konsulent virksomhed, hvor kunden er i centrum.

Jobbet indebærer:

Som Clinical Supply Logistic Coordinator i distributionsteamet vil du få såvel selvstændigt som delt ansvar for planlægning og koordinering af forsendelser og levering af medicin til kliniske studier i hele verden, samt varetage relationer til kunder.

Dit ansvarsområde vil omfatte:

  • Tæt dialog internt i teamet og samarbejde med Supply Coordinators og Managers
  • Udarbejdelse af kundespecifikke distributions –instruktioner
  • Opsætning af depot aftaler og afklaring af importkrav
  • Udarbejdelse af forsendelsesdokumentation
  • Anvendelse af IRT systemer
  • Planlægning og koordinering af distribution af medicin til sites og depoter
  • Forberedelse og nedpakning af medicin til forsendelse
  • Tæt samarbejde med kurerfirmaer
  • Koordinering af returmedicin
  • Koordinering og samarbejde med andre CMO/CRO´er
  • Arkivering (PSF)

Den ideelle kandidat er dedikeret og engageret i at skabe og levere løsninger, der opfylder den enkelte kundes behov. Desuden skal personen være positiv, proaktiv og kunne sætte sig ind i kundens behov.

Faglige kvalifikationer:

  • Distributionskoordinator, Farmakonom, Laborant, eller anden relevant uddannelse med erfaring fra den farmaceutiske industri.
  • GMP og GDP erfaring
  • IT kundskab på brugerniveau
  • Beherske engelsk i skrift og tale til arbejdsformål

Personlige kvalifikationer:

  • Selvstændig
  • Fleksibel
  • Systematisk
  • Ansvars- og kvalitetsbevidst
  • Serviceminded
  • Gode samarbejds- og kommunikationsevner
  • Kan lide en travl og omskiftelig hverdag

Vi tilbyder:

  • Arbejdstid 37 timer
  • Et udfordrende arbejde i et velfungerende team
  • Gode muligheder for udvikling
  • Godt socialt arbejdsmiljø
  • Løn efter kvalifikationer, inkl. pensionsordning
  • Sundhedsforsikring

Lokation:

KLIFO har kontorer i Danmark, Tyskland og Sverige. Denne stilling er på vores lokation i Glostrup, Danmark.

Kontakt:

Hvis du har lyst til at høre mere om jobbet, kan du kontakte Aske Engsbro-Jansson, Director Clinical Trial Supply, @ moc.ofilk@nossnaj-orsbgne.eksa eller

Tlf: +45 44 222 995

Ansøgning sendes til:

moc.ofilk@bojmrk. Clincial Supply Logistic Coordinator.

KLIFO behandler din ansøgning og alle relaterede personoplysninger udelukkende til den specifikke ansættelsesproces og vi behandler dine personoplysninger som fortrolige oplysninger, jf. den gældende persondatalov (GDPR).

Deadline: 26 November 2019

View job post as a PDF.

KLIFO is an established and integrated drug development consultancy with offices in Denmark and Germany. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement. Further information about KLIFO can be found at www.klifo.com


Clinical Supply Coordinator

Clinical Supply Coordinator, Glostrup, Denmark


KLIFO is looking for a Clinical Supply Coordinator for our Glostrup office

The position as Clinical Supply Coordinator:

As a Clinical Supply Coordinator in the packaging area you will be the link between Supply Management and the packaging area and also take part in the daily packaging operations. The main job functions are:

  • Coordinate and collaborate with Clinical Supply Management and QA
  • Updating the packaging schedule
  • Proactively secure the packaging flow
  • Give input to packaging designs
  • Participate in packaging operations
  • Review of batch documentations

The qualifications of the Clinical Supply Coordinator:

The ideal candidate is a person committed to work according to individual customer needs. The person must have a positive, proactive and flexible personality. Preferred skills are:

  • Pharmaconomist, operator or experience from similar job function eg. Clinical Trial Pacakging
  • Knowledge of GMP related to Clinical Trial packaging
  • Preferred knowledge of printing labels
  • Ability to work in a flexible and changing team environment
  • A high-quality mindset
  • Ability to prioritise different tasks to meet strict timelines
  • Language: Danishspeaking and read and understand English

We offer:

  • An inspiring working environment in a rapid developing company
  • Supportive colleagues
  • High job variation
  • Salary according to qualifications

Location:

KLIFO has offices in both Denmark, Germany and Sweden. This position is located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Senior Director, Henriette Pedersen at +45 44 222 962.

Application:

Applications for the job must be send to moc.ofilk@boj, marker ‘Clinical Supply Coordinator’.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

Deadline: 10 February, 2019.

KLIFO is an established and integrated drug development consultancy with offices in Denmark and Germany. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement.

Further information about KLIFO can be found at www.klifo.com

View job post as a PDF.


Clinical Trial Assistant (CTA) - Munich, Germany

Clinical Trial Assistant (CTA) – Munich, Germany


KLIFO is looking for a Clinical Trial Assistant (CTA) for our Munich office 

KLIFO A/S is a service provider of drug development competences and operational services to the pharmaceutical, biotech and med-tech companies in Europe, US and Asia. The areas covered by KLIFO include Clinical Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling. KLIFO A/S has offices in Denmark, Sweden and Germany. 

The German office (KLIFO GmbH) now wants to appoint a Clinical Trial Assistant for the conduct of clinical trials into a dynamic and experienced team within Clinical Operations Solutions in its Munich office. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible, free and trustful working climate with exciting customers and projects among competent colleagues where your knowledge, experience and contribution are valuable and highly appreciated. 

The position as Clinical Trial Assistant: 

  • The CTA is responsible for providing comprehensive support to the clinical team for the set up and administration of projects: 
  • Supporting the Project Manager and the Clinical Research Associates in the documentation, filing and management of projects, e.g. clinical trials 
  • Preparation and updating of project data base, the Trial Master Files and Investigators Files 
  • Participation in the preparation of trial documents for submissions to Competent Authorities and Ethics Committees/Institutional Review Boards 
  • Support of development of clinical trial filing plan 
  • Management of shipment/retrieval of study materials 

The qualifications of the Clinical Trial Assistant:

  • B.Sc. in the life sciences field, medical education or comparable knowledge 
  • Advantageous: knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes 
  • Good communication skills (written and verbal) in German and English 
  • Microsoft office skills 
  • Organizational skills 
  • Accurate and precise with attention to details 

In addition to the above-mentioned qualifications the ideal candidate is a collaborative team player and has focus on service. 

We offer

  • Work within different therapeutic areas and with tasks of varying complexity 
  • Work with a heterogeneous client pool (pharmaceutical companies, established biotech, inexperienced biotech, investigators/academia) 
  • Use – and elaborate – your competences and experience 
  • Work in an interactive, flexible and positive working environment 
  • A team of experienced colleagues 
  • Work in a European-based company with global reach 
  • Permanent employment, part-time employment possible (80%) 

Location:

KLIFO has offices in both Denmark, Germany and Sweden. This position is located at our office in Munich, Germany. 

Contact:

For more information, please contact Doris Wiegel, Managing Director KLIFO GmbH at +49 89 895286-0. 

Applications should be sent to:

moc.ofilk@boj, marked ‘CTA Munich Office’.

KLIFO processes your application and all related personal data exclusively for the specific hiring process. Your data is processed as confidential information, cf. the current data protection law (GDPR).

KLIFO is an established and integrated drug development consultancy with offices in Denmark and Germany. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement.

Further information about KLIFO can be found at www.klifo.com

View job post as a PDF.