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.