Project Manager / Senior Project Manager - Clinical Operations Solutions, Glostrup, Denmark

Project Managers / Senior Project Managers


KLIFO is looking for a talented and committed Project Managers / Senior Project Managers for our Glostrup office

KLIFO is expanding our office in Denmark and wants to engage an eTMF 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.

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
  • Solid 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

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

Contact:

For more information, please contact Stefan Ingelsson, Team Manager, at +45 91 894 818 or Jennie Wilborgsson, Clinical Research Director, at +45 93 638 820

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: 31 August, 2021 (although applications are reviewed on an ongoing basis)

View job post as a PDF.


Clinical Supply Manager

Clinical Supply Manager


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

Would you like to use your solid experience within the pharmaceutical industry to join our highly skilled Clinical supply department as Clinical Supply Manager?

We are growing and we need more dedicated colleagues to help us maintain and further develop our high quality level.

The position:

As Clinical Supply Manager you will be working with a diversity of tasks from planning and coordinating clinical trials in close dialogue and cooperation with our clients, to preparation and approval of labels texts according to Annex 13, packaging materials, designs and blinding setups, coordinating return & destruction of IMP and cooperating with our distribution team in preparing distribution set ups.

As our Clinical Supply Manager you will also coordinate and collaborate with other CMO/CRO’s ensuring a highly qualified service level towards our clients.

Qualifications:

The ideal candidate is a person committed to create and deliver solutions that meet individual customer needs.
Also, the person must have an independent, positive, proactive and flexible personality.
Our candidate is experienced with GMP and experienced within the pharmaceutical industry.

We offer:

As our new Clinical Supply Manager you will be part of an inspiring working environment in a growing
company. You will work with exciting customers among competent colleagues where your knowledge, experience and contribution is highly valued. You will also get:

  • High job variation
  • High level of influence
  • Great social working environment and committed colleagues
  • A highly flexible, free and trustful culture

Location:

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

Contact:

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

Applications should be sent to:

moc.ofilk@bojmarked “Clinical Supply 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: 13 September 2021 (although applications are reviewed on an ongoing basis)

View job post as a PDF.

KLIFO is a leading integrated drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies to advance their drug development projects. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement. KLIFO has offices in Denmark, Sweden, Germany and the Netherlands and employs more than 150 highly skilled employees.

Join KLIFO and work together with some of the most experienced colleagues in the life-science industry. We have strengthened our competences over many years of dedication to our field of expertise, and we support and learn from each other. This gives us a positive, flexible and informal working environment and allows us to grow as individuals and as a company.

For more information, visit www.klifo.com


CTS/QA Proposal Manager

CTS/QA Proposal Manager


KLIFO is looking for a CTS/QA Proposal Manager for our Glostrup office

The position as CTS/QA Manager:

  • Close dialog and cooperation with our customers
  • Preparation of proposals to customers
  • Preparation of Change orders and current budgets
  • Preparation and updates of contracts and work orders
  • Close dialog with proposal Managers and controllers
  • Participating in meetings with customers
  • Have full overview of incoming activities in CTS
  • Ensure high quality level to meet customer and KLIFO requirements
  • Additional support to KLIFO QMS work

The qualifications of the CTS/QA Proposal Manager:

An ideal candidate is a person committed to creating and delivering solutions that meet individual customer needs. IT skills within Microsoft office programs on a user level.  Also, the person must have an independent, positive, proactive and flexible personality. Good communication skills in Danish and English. Business oriented.
Our candidate is experienced with GMP and Clinical Trial Supply.

We offer:

  • An inspiring working environment in a growing company
  • High job variation
  • High level of influence
  • Good social working environment and committed colleagues
  • Salary according to qualifications

Location:

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

Contact:

For more information, please contact Christina Vinum, Vice President, at +45 44 222 960 or Tina Lindhardt, Proposal Manager, at +45 44 222 987

Applications should be sent to:

moc.ofilk@bojmarked “Proposal 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: August 10, 2021

View job post as a PDF.

KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany, Sweden and The Netherlands. 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