Clinical Supply Coordinator

Clinical Supply Coordinator


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

The position as Clinical Supply Coordinator:

As a Clinical Supply Coordinator you will support Clinical Supply Managers and be involved in supply activities, such as:

  • Prepare and approve label text according to Annex 13
  • Order packaging materials and labels
  • Prepare packaging records and other study specific documents
  • Control printed study specific labels
  • Coordinate return and destruction of IMP
  • File GxP documents
  • If relevant; Plan, coordinate and handle smaller clinical trials
  • Coordinate and collaborate with other CMO/CRO’s
  • Ensure high quality level to meet customer and KLIFO requirements

 

The qualifications of the Clinical Supply Coordinator:

An ideal candidate is a person committed to creating and delivering solutions that meet individual customer needs.

Also, the person must have a positive, proactive and flexible personality.

 

Education, experiences, knowledge and skill:

The candidate must have relevant competencies and experiences including:

  • Pharmaconomist or equivalent
  • Experience from the pharmaceutical industry, biotech or CRO, preferably as a Clinical Supply Coordinator or similar
  • Ability to work in a flexible and changing environment
  • A high-quality mindset
  • Ability to prioritise different tasks to meet strict timelines
  • Team oriented personality with high degree of flexibility
  • Good communication skills (written and oral), in both Danish and English

 

We offer:

  • An inspiring working environment in a growing company
  • High job variation
  • High level of influence
  • Salary according to qualifications

 

Location:

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

 

Contact:

For more information, please contact Lotte Harreby, Director at +45 44 222 969 or Pernille Smith, Team Leader at +45 44 222 986

 

Applications should be sent to:

moc.ofilk@boj, marked ‘‘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: 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 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.

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 conducted by KLIFO, i.e.:

  • Supporting the Project Manager and the Clinical Research Associates in the management of clinical trials
  • Preparation and updating of the Trial Master Files and Investigators Files
  • Management of shipment/retrieval of study materials
  • Supporting the Project Manager in Investigators and Monitors 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
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Good communication skills (written and verbal), good English
  • 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.

Location:

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

Contact:

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

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: 28th October 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


Project Manager - Clinical Operations Solutions, Glostrup, Denmark

Project Manager


KLIFO is looking for a Project Manager for our Glostrup office

KLIFO is expanding 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 overall responsible for managing the clinical trials, i.e.:

  •  Management of assigned project in all phases, from start-up to the end of the trial
  • Leadership of people involved in the project (CRAs, CTA, etc.)
  • Investigational site selection in order to assure the quality and conformity of the sites
  • Attending cross-functional project team in relation to trial(s)
  • Operational and scientific input to key project documents
  • Continuous relationship with the Principal Investigators and Sponsor to assure the success of the trial in terms of enrolment and quality
  • Management and resolution of issues occurring during the trial
  • Generation and management of Project Plans
  • Investigators and Monitors training and organization of meetings
  • Elaboration of trial specific procedures
  • Participation in data management activities

The qualifications of the Project Manager:

The Project Manager should possess the following qualifications:

  • MSc in the life sciences field and a minimum of 5-6 years of overall experience out of which 2 years must be in project management in the pharmaceutical industry/BioTech/CRO
  • 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 verbal and written communication skills
  • Computer skills, ability to develop and maintain excel spreadsheets and to generate PowerPoint presentations

In addition to the above-mentioned qualifications the ideal candidate is a dedicated and collaborative team player that possesses excellent planning skills 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 has offices in  Glostrup, Denmark, Munich, Germany and Lund, Sweden. This position is located at our office in Glostrup

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

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

Applications should be sent to:

moc.ofilk@boj, marked ‘Project Manager‘ before 15 October 2019.

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

Project Manager


KLIFO is looking for a Project Manager for our Glostrup office

KLIFO is expanding 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 overall responsible for managing the clinical trials, i.e.:

  • Management of assigned project in all phases, from start-up to the end of the trial
  • Leadership of people involved in the project (CRAs, CTA, etc.)
  • Investigational site selection in order to assure the quality and conformity of the sites
  • Attending cross-functional project team in relation to trial(s)
  • Operational and scientific input to key project documents
  • Continuous relationship with the Principal Investigators and Sponsor to assure the success of the trial in terms of enrolment and quality
  • Management and resolution of issues occurring during the trial
  • Generation and management of Project Plans
  • Investigators and Monitors training and organization of meetings
  • Elaboration of trial specific procedures
  • Participation in data management activities

The qualifications of the Project Manager:

The Project Manager should possess the following qualifications:

  • MSc in the life sciences field and a minimum of 5-6 years of overall experience out of which 2 years must be in project management in the pharmaceutical industry/BioTech/CRO
  • 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 verbal and written communication skills
  • Computer skills, ability to develop and maintain excel spreadsheets and to generate PowerPoint presentations

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

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

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

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

Applications should be sent to:

moc.ofilk@boj, marked ‘Project Manager‘ before 6th September 2019.

View job post as a PDF.


Clinical Research Associate (CRA) - maternity cover

Clinical Research Associate (CRA) – Maternity cover


KLIFO is looking for a Clinical Research Associate (CRA) for a one year maternity cover for our office in Glostrup

KLIFO A/S would like to engage a CRA in a one year maternity cover position. The people we want to engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and collaborative personality. We can offer a highly flexible and trustful working climate with exiting projects among competent colleagues where your contribution is valuable and makes a difference.

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 Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.

The position as CRA:

The CRA is responsible for the pro-active site management including monitoring activity of trials, i.e.:

  • 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, 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 a project manager for trial related deliverables

The qualifications of the CRA:

The CRA should possess the following qualifications:

  • B.Sc. in the life sciences field or CRA specific diploma and a minimum of 2 years in a similar position in the pharmaceutical industry/BioTech/ CRO
  • Extensive knowledge of GCP guidelines, applicable requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Excellent verbal and communication skills
  • Excellent computer skills, ability to develop and maintain excel spreadsheets and to elaborate PowerPoint presentations
  • Strong organisational skills with attention to details

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)
  • 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.

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

Contact:
For more information, please contact Tina Hjorth, Clinical Research Director of COS at + 45 44 222 934.

Applications should be sent to:

moc.ofilk@boj, marked ‘Clinical Research Associate‘ before 01 September 2019.

View job post as a PDF.


Senior Regulatory Affairs Specialist, DE

Senior Regulatory Affairs Specialist, Munich, Germany


KLIFO is looking for an enthusiastic and self-motivated individual to develop our regulatory affairs team in Munich, Germany

The position

KLIFO is an integrated drug development consultancy with headquarters in Denmark. In early 2019, KLIFO acquired medicomp GmbH, a Munich-based company providing life science services to pharmaceutical, medical device and biotech companies. The acquisition of medicomp is part of KLIFO’s strategy to expand the company’s operational footprint. 

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

The Senior Regulatory Affairs Specialist will be responsible for building up and leading a Munich-based regulatory affairs team and supporting the establishment of new regulatory affairs business in Germany and the DACH region. In addition, the position requires a hands-on approach to service existing and new clients. The successful candidate will report to the Head of New Business in Munich and work in close collaboration with the Vice President, Regulatory Affairs Solutions from company headquarters in Denmark.

Functions as Regulatory Affairs team Leader 

  • Identify and recruit candidates with solid regulatory affairs experience, in close collaboration with the HQ regulatory affairs team
  • Provide leadership for the Munich-based regulatory affairs team as it grows
  • Client liaison, project execution and oversight to ensure client satisfaction
  • Develop the regulatory affairs business with current and potential DACH-based clients
  • Promote KLIFO and its integrated drug development solutions offering by participating in conferences and other networking events etc

Functions as Senior Regulatory Affairs Affairs Specialist

  • Project management
  • Strategic advice
  • Liaison with competent authorities
  • General regulatory affairs work
  • Management of regulatory procedures
  • Preparation and submission of regulatory documents, e.g. (non-exhaustive list):
  • Briefing packages
  • IMPD
  • CTA/IND 
  • ODD
  • PIP
  • MAA/BLA/NDA
  • Project management and cross-functional collaboration within KLIFO
  • Support to projects in other KLIFO departments
  • Writing and reviewing of SOPs

Qualifications and requirements

  • MSc from the life sciences field or Regulatory Affairs specific diploma/master and a minimum of 15 years’ experience within Regulatory Affairs 
  • Profound knowledge of regulatory guidelines, terminology and processes
  • Experience in liaison with Medicines agencies especially PEI and BfArM
  • Broad knowledge of the key drug development steps
  • Proven track record with good leadership skills
  • Collaborative mind-set
  • Personal fit with KLIFO’s culture and way of working
  • Extrovert service oriented (client-centric) mindset, preferably with experience from pharma and biotech as well as service provider side
  • Able to work internationally
  • Passion for developing the KLIFO regulatory affairs business provided out of the Munich office
  • Network of regulatory experts in DACH
  • Excellent communication skills, fluent in German and English (both written and verbal)
  • Experienced user of MS Office and good understanding of databases
  • Strong organisational skills with attention to details
  • Willingness to work from client sites, when required
  • Ability to travel for work (in Europe, up to 25%)

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 a European-based company with global reach 
  • Work in an interactive, flexible and positive working environment with a high-level of transparency and influence
  • Flexibility to work partially home-based

The position is located at KLIFO GmbH, Heimeranstr. 35, Munich Germany

Applications

Applications, including salary expectations, should be sent to Christine Tiesler, Head of New Business, KLIFO GmbH at moc.ofilk@relseit.enitsirhc.

View job post as a PDF.

For more information about KLIFO, visit www.klifo.com.


TOPRA Annual Symposium, Dublin, Ireland

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Project Manager DE

Project Manager


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

KLIFO A/S is expanding and just established its first subsidiary outside Denmark in Munich, Germany. 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 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 Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.

The position as Project Manager (PM):

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

  • Management of assigned trials in all phases, from start-up to the end of the project, both as overall project manager in close collaboration with the sponsor and as local project manager faithfully managing the local study responsibilities in the context of a larger study setting
  • Leadership of people involved in the project (CRAs, CTA, etc.)
  • Training and supervision of external staff and subcontractors
  • Investigational site selection in order to assure the quality and conformity of the sites
  • Coordinating cross-functional project teams in relation to trial(s)
  • Operational and scientific input to key project documents
  • Continuous relationship with the Principal Investigators and Sponsor to assure the success of the trial in terms of enrolment and quality
  • Management and resolution of issues occurring during the trial
  • Generation and management of Project Plans
  • Coordination and Implementation of Risk Management Activities
  • Training of Investigators and Monitors and organization and conduct of appropriate meetings
  • Elaboration of trial specific procedures
  • Monitoring of selected sites, e.g. KoL

The qualifications of the Project Manager:

The Project Manager should possess the following qualifications and skills:

  • 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 thepharmaceutical 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 andbudget
  • 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)

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)
  • 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 Denmark is located in Glostrup and KLIFO GmbH (formerly medicomp GmbH) is located in 80339 Munich, Heimeranstr. 35, Germany. Further information about KLIFO can be found at www.klifo.com

Applications, including salary expectations, should be sent to:

moc.ofilk@boj

View job post as a PDF.


Biometrician/Biostatistician

Biometrician/Biostatistician


KLIFO is looking for a talented and committed Biometrician/Biostatistician

KLIFO A/S is expanding and is expanding and has just established its first subsidiary outside of Denmark – in Munich, Germany. KLIFO GmbH is looking to appoint a Biometrician/Biostatistician for the planning, analysis and reporting of clinical trials. The successful candidate will be part of a dynamic and experienced team within Clinical Operations Solutions and will work from our offices in either Munich or near Copenhagen, Denmark. The people we want to engage have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a highly flexible and trust-based working environment 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 Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.

The position as Biometrician/Biostatistician within Clinical Operations Solutions:

Responsibilities of the Biometrician/Biostatistician include:

  • Act as the primary contact person for our customers concerning trial-related statistical aspects
  • Provide statistical consultancy on general or trial‑related aspects, internally and externally
  • Cooperate closely with data managers, SAS®programmers and project managers
  • Coordinate small teams of SAS®programmers, perform quality control of SAS®programs
  • Statistical planning of clinical trials: provide statistical input to trial designs and perform sample size calculations
  • Writing or peer review of the statistical sections of clinical trial protocols
  • Writing or peer review of statistical analysis plans
  • Perform statistical analyses using SAS®
  • Provide statistical contributions to clinical trial reports
  • Provide statistical support for publications
  • Support maintenance and further development of internal standards and of Standard Operating Procedures.

The qualifications of the Biometrician/Biostatistician:

The Biometrician/Biostatistician should possess the following qualifications and skills:

  • Diploma or master in (bio-)statistics, mathematics or comparable degree
  • Professional experience with planning, analysis and reporting of clinical trials in the pharmaceutical or biotech industry, in a CRO or in an academic environment
  • Knowledge of relevant regulatory guidelines
  • Profound knowledge of SAS®and Microsoft®Office
  • Familiarity with CDISC standards
  • Quality orientation, efficiency, and reliability
  • Customer orientation and flexibility
  • Willingness to travel occasionally
  • Excellent verbal and written communication skills
  • Fluent in English (spoken and written), and in either German or Danish.

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 varyingcomplexity
  • 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 a European-based company with global reach
  • 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 Denmark is located in Glostrup and KLIFO GmbH (formerly medicomp GmbH) is located in 80339 Munich, Heimeranstr. 35, Germany. Further information about KLIFO can be found at www.klifo.com

Applications, including salary expectations, should be sent to:

moc.ofilk@boj marked “Biometrician/Biostatistician”

View job post as a PDF.


Data Manager/Programmer Clinical Trials

Data Manager/Programmer Clinical Trials


KLIFO is looking for a talented and committed Data Manager/Programmer

KLIFO A/S is expanding and has just established its first subsidiary outside of Denmark – in Munich, Germany. KLIFO GmbH is looking to appoint a Data Manager/ Programmer for clinical trials. The successful candidate will be part of a dynamic and experienced team within Clinical Operations Solutions and will work from our offices in either Munich or near Copenhagen, Denmark. The people we want to engage have a positive, proactive, flexible, self-driven and self‑confident personality. We can offer a highly flexible and trust-based working environment 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 Trial Supply Solutions, Clinical Operations Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.

The position as Data Manager/Programmer within Clinical Operations Solutions:

Responsibilities of the Data Manager/Programmer include:

  • Cooperate closely with biostatisticians, medical reviewers and project managers
  • Database set-up and testing, usually within an eCRF system
  • Set-up and testing of online edit checks
  • Program (within the 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 (in SAS®) of data listings for clinical study reports
  • Perform quality control of programs
  • Writing or peer review of Data Management Plans and Data Validation Plans
  • Continuous data cleaning, data base lock
  • Support maintenance and further development of internal standards and of Standard Operating Procedures
  • Contribute to harmonization of data management processes between KLIFO offices.

The qualifications of the Data Manager/Programmer:

The Data Manager/Programmer should possess the following qualifications and skills:

  • Professional data management experience in the pharmaceutical or biotech industry, in a CRO or in an academic environment
  • Experience with the use of eCRF systems to set up eCRFs and online checks and to perform continuous data management activities
  • Very good SAS®programming skills are important
  • Familiarity with CDISC standards
  • Knowledge of relevant regulatory guidelines
  • Analytical thinking, familiarity with medical terminology
  • Quality orientation, efficiency, and reliability
  • Customer orientation and flexibility
  • Willingness to travel occasionally
  • Fluent in English (spoken and written) and in German.

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 varyingcomplexity
  • 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 a European-based company with global reach
  • 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 GmbH (formerly medicomp GmbH) is located in 80339 Munich, Heimeranstr. 35, Germany.

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

Applications, including salary expectations, should be sent to:

moc.ofilk@boj, marked “Data Manager/Programmer

View job post as a PDF.