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.

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 Dr. Michaele Kupka, Team Manager CRAs & Project Manager at +49 89 895286-0

Applications should be sent tojob@klifo.com 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).

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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.