Clinical Operations Project Manager, Glostrup, Denmark

Clinical Operations Project Manager


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

KLIFO is expanding and wants to engage a Project Manager 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, Regulatory Affairs Solutions, CMC Development Solutions, Clinical Trial Supply Solutions, QA Solutions and Drug Development Counselling.

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:

The Project Manager should possess the following qualifications:

  • BSc/MSc in the life sciences field or related discipline and a minimum of 3-4 years in a similar position in the pharmaceutical industry/CRO
  • Experience within clinical trial management
  • 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 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 in both Denmark, Germany and Sweden. This position can either be located at our office in Copenhagen, Denmark or at our office in Lund, Sweden.

Contact:

For more information, please contact Jennie Wilborgsson, Clinical Research Director, COS, at +45 93 638 820. 

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

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 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.


QA Specialist/Senior QA Specialist, Glostrup, Denmark

QA Specialist/Senior QA Specialist, GCP and GVP

 


KLIFO is looking for a QA Specialist/Senior QA Specialist, GCP and GVP, for our Glostrup office

The position as QA Specialist/Senior QA Specialist:
We are a growing QA department where we need a new colleague with competencies regarding GCP and GVP. GLP experience will be a benefit. The job will be a mixture of internal and external QA activities.

The external activities can be:

  • QA consulting to Clients
  • Provide various QA services to Clients. E.g.:
    o Develop or update QMS system
    o GAP analysis
    o Help to become Inspection ready
  • Performing worldwide Client Audits

The internal tasks will mainly be:

  • Maintain the Quality Management System within the Clinical Area
  • Perform Training within the Clinical area
  • Ensure execution of the Clinical audit program
  • Participate in KLIFO projects as QA representative
  • Beside the above activities, be responsible for KLIFOs GDPR compliance review program.

The qualifications of the QA Specialist/Senior QA Specialist:
You are MSc in the life science field and the ideal candidate for the position is a trained lead auditor with at least 7 years of QA experience within GCP and GVP in the pharmaceutical industry. GLP QA and GLP auditing experience is considered a benefit.
You must be flexible and service-minded, a team player but also thrive working as a consultant and be capable of taking on a varity of different tasks and make decisions on your own.
Willingness to work from client sites, when required and to travel to the extend necessary.
Fluent in one of the Scandinavien languages and in English.

We offer:
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 dynamic, flexible and positive working environment in a rapidly developing company.
You will experience a high-level of transparency and influence

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 Anne Ploug Jørgensen, Director, QA, mobile phone +45 44 222 982.

Applications should be sent to: moc.ofilk@boj marked QA Specialist/Senior QA Specialist GCP and GVP.
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: 19.06.2020, but recruitment interviews will be held on an ongoing basis.

View job post as a PDF.

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


Financial Controller, Munich, Germany

Financial Controller, Munich, Germany


KLIFO is looking for a Financial Controller for our Munich office 

KLIFO GmbH offers a job where you can greatly influence the development of local controlling and accounting. 

As the position as Financial Controller is new, an important role will be to develop, implement and execute local finance procedures and reports that supports the business, Group reporting and local requirements for reporting. 

You will have the full responsibility for financial support to our business in Germany and for delivering timely and correct reporting to our head office in Denmark. 

Accounting is outsourced, so you will have a close collaboration with the accounting firm in Munich, who takes care of bookkeeping, payroll, VAT and Tax calculations and yearly reporting to authorities. 

You will report to our General Manager in Munich with a dotted line to our CFO in Denmark. 

The position as Financial Controller:

  •  Based on Group reporting requirements, prepare correct and timely monthly reporting to KLIFO Group Finance 
  • Support local business in calculation of proposals to clients 
  • Prepare monthly invoicing to clients 
  • Prepare correct monthly recognition of income on projects with milestone payments 
  • Support and train local organisation in finance questions 
  • Close collaboration with outsourced local accounting company 
  • Develop relevant and needed processes and templates (excel) to support calculation of proposals, estimates, invoicing etc. 
  • In collaboration with Group Finance coordinate and prepare budget 

The qualifications of the Financial Controller:

  • Some years of experience as controller from a project based organisation.
  • Fluent in German and English 
  • Skilled user of Excel. 
  • Good communication skills 
  • Teamplayer 

We offer:

An opportunity to develop controlling and finance in a small organisation with a strong and dedicated plan for growth. We prioritize a positive working environment with opportunities to develop your skills. 

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 CFO Michael Krak at +45 44 222 901 

Applications should be sent to: moc.ofilk@boj marked ‘Financial Controller’.

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.

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 Operations Project Manager, Glostrup, Denmark

Clinical Operations Project Manager


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

KLIFO is expanding and wants to engage a Project Manager with early clinical development experience 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: 

  • Planning, delivery and management of clinical trial activities (start-up, operational conduct and closure) according to SOPs and a responsibility split with Sponsor
  • Lead the clinical trial team and coordinate and manage all activities related to clinical trials in phase I-III
  • 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.

The qualifications of the Project Manager:

  • MSc in the life sciences field and a minimum of 5-6 years of overall experience out of which 3 years must be in project management in the pharmaceutical industry/BioTech/CRO
  • Experience with conduct of phase I trials
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Demonstrated project management skills including the ability to plan a project and operate within plan and budget
  • Excellent communication skills in English
  • Microsoft Office Skills

We offer:

KLIFO offers a job where you can: 

  • 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.

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 Jennie Wilborgsson, Clinical Research Director, COS, at +45 93 638 820. 

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

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: 28 February 2020.

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 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 Trial 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.


Data Manager - Munich, Germany

Data Manager – Munich, Germany


KLIFO is looking for an experienced Data Manager for our Munich office

The position as Data Manager:

The Data Manager is responsible for data management deliverables on projects conducted by KLIFO:

  • Act as the primary contact person for clients concerning data management aspects
  • Provide data management consultancy on general or trial related aspects
  • Cooperate closely with study team members such as biostatisticians, medical reviewers and project managers
  • Writing or peer review of Data Management Plans and Data Validation Plans
  • Coordination and instruction of data entry personnel, data entry
  • Database set-up and testing, within an eCRF system or using SAS, including relevant documentation
  • Set-up and testing of online edit checks
  • Programming and tracking of queries
  • Program (within an eCRF system or in SAS®) various listings, overviews and summary tables for medical reviewer, status reports, project management; provide updated outputs on a regular basis
  • Support programming of data listings for clinical study reports
  • Perform quality control of programs and of customisations of software, e.g. UAT of EDC, including relevant documentation
  • Continuous data cleaning, data base lock
  • Medical coding according to MedDRA and WHO-DD
  • Arrange data import/export from/to external sources (e.g. central laboratory)
  • Provide input to Risk Based Quality Management (RBQM) including risk assessment and risk controls
  • Support maintenance and further development of internal standards and of Standard Operating Procedures

Qualifications of the Data Manager

  • Education in computer science, medical documentation or other relevant discipline, or a minimum of 3 years in a similar position in the pharmaceutical or biotech industry, in a CRO or in an academic environment
  • Ability to translate client’s needs into data management practice
  • Knowledge of relevant regulatory guidelines and data protection requirements
  • Good knowledge of SAS®
  • Good knowledge of Microsoft Office
  • Good verbal and written communication skills
  • Good knowledge of English (spoken and written)
  • Understanding of medical terminology and relevant coding dictionaries (MedDRA, WHO-DD)

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

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
  • A team of experienced colleagues
  • Work in an interactive, flexible and positive working environment

Location:

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

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 ‘Data Manager Munich Office’.
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).

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 Research Associate (CRA) - Munich, Germany

Clinical Research Associate (CRA) – Munich, Germany


KLIFO is looking for an experienced Clinical Research Associate (CRA) for our Munich office

The position as Clinical Research Associate:
The CRA has considerable knowledge and is responsible for assistance of the Project Manager and conduct of monitoring activities:

  • Participation in the preparation of trial documents for submissions to Competent Authorities and Ethics Committees/Institutional Review Boards
  • 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
  • Support to data management activities
  • Continuous relationship with the Principal Investigators and trial staff to assure the success of the trial in terms of enrolment and quality
  • 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 of essential documents
  • Liaison between sponsors, investigators and vendors

Qualifications of the Clinical Research Associate

  • Sc. in the life sciences field or CRA specific diploma
  • 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 or comparable level (e.g. able to translate patient documents or ICFs into German, able to talk and email in German with site personnel)
  • Excellent computer skills, ability to develop and maintain excel spreadsheets and to elaborate PowerPoint presentations
  • Strong organizational and planning skills
  • Accurate and precise with attention to details
  • Ability to motivate

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 affiliate in Munich.

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 CRA Munich Office.
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).

Deadline: 18 December 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.