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.


Finance Manager

Finance Manager


KLIFO is looking for a Finance Manager for our Glostrup office

KLIFO has grown significantly over the last years both in Denmark and through subsidiaries in Germany, Netherlands and Sweden. To support the growth, KLIFO is now looking for a Finance Manager, who can develop and professionalize accounting at local and group level.

The position is new and it gives you the opportunity to build and develop local and group Accounting in KLIFO.

You will have a team of two accountants in Denmark and you will work closely with the controller in Germany and the external accountants in Sweden and Netherlands.

KLIFO is a rapidly growing company, therefore it is important that you thrive in a growing organization and you are able to be hands-on and at the same time maintain the overview.

You report to KLIFO’s CFO and will collaborate and align with the controllers of the Service Areas. Together with your finance colleagues you prepare the reporting and develop finance related policies, processes and tools

Your primary tasks will be:

  • Daily management of the accounting department
  • Ensure correct processes and month-end closure
  • Consolidate KLIFO Group P&L and balance sheet on a monthly basis
  • Prepare monthly Cash-flow report and estimate
  • Prepare annual report
  • Develop Finance Policies and ensure implementation in subsidiaries
  • Participate in implementation of new finance systems

Qualifications:

  • You have a solid accounting and finance foundation including consolidation of foreign subsidiaries
  • A relevant education such as HD (R) or Cand.merc.aud with minimum 3-5 years relevant experience as either auditor or from similar position in a project driven company
  • You are self-driven and you know how to create motivation and good atmosphere in your department
  • You are professionally skilled and work naturally with optimizing/automating work processes
  • You can work independently, but are also a dedicated team player who values collaboration
  • You are an experienced user of Excel and preferable you have experience using Dynamics Nav
  • You are fluent in Danish and in English

We offer:

KLIFO offers a position in a growing company where you will have the opportunity to influence decisions and develop your competences in collaboration with dedicated colleagues.

Location:

Position is located at our office in Glostrup, Denmark.

Contact:

For more information, please contact CFO Michael Krak at 44 222 900

Applications should be sent to: moc.ofilk@boj marked Finance 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: 18 August 2021

We review applications and invite for interviews on an ongoing basis.

 

View job post as a PDF.


Business/Project Controller

Business/Project Controller


KLIFO has grown significantly over the last years both in Denmark and through subsidiaries in Germany, Netherlands and Sweden. To support the growth, KLIFO is now looking for a Business/Project controller, who can be a pro-active support for the management of 3 service areas

All service areas are well-established in Denmark and in the process of expanding the business in the other countries. You will work closely together with management and project managers in all countries.

The position includes many aspects and you thrive just as well with daily hands-on work as analysis on future business. You will spare on financial topics with management, prepare monthly reporting and take care of the monthly invoicing in collaboration with project managers.

You report to KLIFO’s CFO and you will work closely with management of the service areas. Further, you will have collaboration with the controllers working for the other service areas and with accounting. Together with your finance colleagues you prepare the reporting and develop finance related policies, processes and tools

Your primary tasks will be:

  • Daily financial sparring with service area management and project managers
  • In collaboration with management prepare budgets and estimates
  • Monthly reporting including analysis and comments
  • Monthly invoicing
  • Prepare analysis to support the yearly business plan
  • Financial sanity check of client contracts

Qualifications:

  • You have experience as controller in a project-based organisation
  • A relevant education such as cand.merc or HD
  • You thrive in a growing organisation
  • You are able to handle many informations, create relevant overviews and communicate clearly
  • You can work independently, but are also a dedicated team player who values collaboration
  • You are an experienced user of Excel and preferable you have experience using Dynamics Nav
  • You are fluent in Danish and in English

We offer:

KLIFO offers a position in a growing company where you will have the opportunity to influence decisions and develop your competences in collaboration with dedicated colleagues.

Location:

Position is located at our office in Glostrup, Denmark.

Contact:

For more information, please contact CFO Michael Krak at 44 222 900

Applications should be sent to: moc.ofilk@boj marked Business/Project 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).

Deadline: 18 August 2021

We review applications and invite for interviews on an ongoing basis.

 

View job post as a PDF.


Business Development Director

Business Development Director


KLIFO is looking for a Business Development Directorfor our Glostrup office

Would you like to become our new colleague and use your life science experience and strong network in a newly established permanent position to identify and generate leads, manage the sales process and win new business?

You will report to VP Drug Development Counselling and CMC, Hanne Wulff Nielsen and work closely with the individual service areas and business development colleagues in Germany and Sweden.

The position

The Director, Business Development is responsible for contributing to business growth and profitability through sales of KLIFO solutions and services to new clients in Denmark. The primary focus of the role is to identify and cultivate qualified leads, manage the sales process and win new business whilst establishing and developing client relationships consistent with KLIFO Group´s culture and values.

You would become part of an international and growing company with a flexible and trustful working climate, healthy leadership, strong focus on and interest in people and a respectful and free culture. We believe that our way of collaborating with each other and with clients is key to our success and we have therefore described it in KLIFO´s “Way of Working” which we´re all using in our daily work.

Qualifications and requirements:

  • M.Sc. with 10-15 years´ experience in the life sciences field
  • Minimum of 5 years´ experience in proven track record in converting leads to deals in a business development or sales role within life science in Europe, ideally Scandinavia.
  • Thorough knowledge of and network within Danish biotech and/or biotech incubators and societies
  • Thorough experience with establishing, developing and maintaining client relationships
  • Specific knowledge about or experience with clinical, CMC or non-clinical development, clinical trial supplies or regulatory affairs is an advantage but not a requirement
  • Experience with life science vendor management and partnerships is an advantage but not a requirement
  • Consultancy experience is desirable but not a requirement
  • English written and spoken at minimum at professional level
  • Willingness to travel

Your main tasks would be:

  • Establish, maintain and own lead oversight for the Danish market in line with the target client profile and business plan objectives for the market
  • Pro-actively engage with potential clients to understand their needs and promote KLIFO capabilities
  • Collaborate closely with KLIFO´s service area heads, proposal managers and other key stakeholders during the sales process
  • Establish confidentiality agreements and prepare and lead client meetings and presentations
  • Support proposal development and write proposals
  • Suggest and implement promotional activities
  • Identify and participate in relevant industry fairs, congresses, events and networks
  • Contribute to further development of KLIFO´s business development capabilities

For your to thrive and be successful in this role you:

  • Enjoy to connect with people and have excellent social and client engagement skills
  • Communicate and present clearly and confidently in writing and verbally, and in Danish and English
  • Maneuver respectfully and curiously in different company cultures
  • Maintain the overview and have a systematic and pro-active approach to your work
  • Have a collaborative mindset and are a flexible team player
  • Thrive in a growing company where infrastructure is under continuous development

Location:

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

Contact:

For more information, please contact VP Drug Development Counselling and CMC, Hanne Wulff Nielsen, at +45 44 222 903.

Applications should be sent to: moc.ofilk@boj marked Business Development Director.

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).

We review applications and invite for interviews on an ongoing basis.

 

View job post as a PDF.


Senior CMC Expert/Senior CMC Project Manger

Senior CMC Expert / Senior CMC Project Manager


KLIFO is looking for a Senior CMC Expert/Senior CMC Project Manager for our Glostrup office

Would you like to use your CMC experience in a permanent position acting as a consultant to support KLIFO’s increasing number of biotech and pharma clients progressing their drug development projects?

We’re looking for a new colleague to become part of our highly experienced CMC team reporting to VP Drug Development Counselling and CMC, Hanne Wulff Nielsen.

We offer a unique opportunity to shape the content of the position and play a significant role in guiding and driving CMC development of a very broad range of international development projects and to deliver on specific CMC tasks. Our team develops tailormade CMC solutions ensuring that what we deliver to KLIFO clients and how we do it is complementary to what the client can do by themselves. Our professionalism is key and your new colleagues would have 20-40 years experience within their field.

You would become part of an international and growing company with a flexible and trustful working climate, strong focus on and interest in people and a respectful and free culture. We’re passionate about understanding our client’s needs and objectives and contribute to their projects as if they were our own.

For you to thrive and to be successful in this role you:

  • Enjoy to contribute to many different projects
  • Maneuver respectfully and curiously in different company cultures and geographies
  • Are pro-active and able to take lead
  • Have a collaborative mindset and are a flexible team player
  • Communicate confidently in writing and verbally and in Danish and English – with attention to detail

Your tasks could be to:

  • Support and advice in formulation development including documentation (protocols, reports, recommendations, presentations)
  • Develop and present CMC gap analyses, CMC strategies and plans
  • Lead CMC teams and conduct CMC project management
  • Identify CRO’s and CMO’s and facilitate collaboration
  • Draft, review or provide input to documents for correspondence with competent authorities (briefing package/scientific advice, IMPD, CTA/IND’s)
  • Prepare or review documentation to support regulatory filing (module 2.3 and module 3)
  • Support upscaling, validation and transfer of manufacturing processes to CMO’s
  • Outline statistical design of experiments
  • Plan and conduct CMC due diligence incl. reporting and recommendation

Qualifications:

  • M.Sc. (pharm.) or diploma in chemical engineering or equivalent
  • +15 years formulation development and CMC project management experience from pharma and/or biotech with either ATMP’s, biologics or small molecules
  • Particularly strong in CMC related to phase I to phase III clinical development
  • Experience preparing regulatory documentation

KLIFO has offices in both Denmark, Germany, Sweden and the Netherlands. This position will be located at our office in Glostrup, Denmark. Most of us work partly from home and partly from the office or at our client´s offices

Contact:

For more information, please contact VP Drug Development Counselling and CMC, Hanne Wulff Nielsen, at +45 44 222 903.
If you want to meet one of your future CMC-colleagues and learn more about their experience working in KLIFO then we´re happy to arrange for that.

Applications should be sent to: moc.ofilk@boj marked Senior CMC Expert.

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).

We review applications and invite for interviews on an ongoing basis.

 

View job post as a PDF.


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 Coordinaor 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.

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
  • 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 Lotte Harreby, Director, at +45 44 222 960 or Pernille Smith, Team Manager, at +45 44 222 986

 

Applications should be sent to:

moc.ofilk@bojmarked “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: 24.07.2021

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


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.


Qualification Manager

Qualification Manager


KLIFO is looking for a Qualification Manager for our Glostrup office

The position as Qualification Manager:

In the qualification team we work with e.g. Qualification of expansions of our facilities, Cold Rooms, Freezers, and validation of IT systems.

Your tasks will include:

  • Planning of qualification activities
  • Planning of Periodic reviews
  • Close dialog and cooperation with Qualification Coordinator and QA
  • Updating Validation Master Plan
  • Create and implement Change Request
  • Generate or approval of protocols and test plans
  • Perform Qualification activities
  • Collect test results and prepare Qualification reports
  • Participating in planning of new equipment and expansions of the facility.

The qualifications of the Qualification Manager:

An ideal candidate is a person committed to Qualification and validation in a GMP environment.
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.
Our candidate is experienced within GMP and computer Qualification.

We offer:

  • An inspiring working environment in a growing company
  • Being part of a competent qualification team
  • 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.

Applications should be sent to:

moc.ofilk@bojmarked “Qualification 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


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


Clinical Supply Manager

Clinical Supply Manager


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

The position as Clinical Supply Manager:

  • Plan and coordinate clinical trials and compassionate use programs
  • Close dialog and cooperation with our customers
  • Prepare and approve label text according to Annex 13
  • Order packaging materials and labels
  • Prepare packaging records and other study specific documents
  • Think out packaging design and blinding setup
  • Prepare distribution set up in coordination with our distribution team
  • Coordinate return and destruction of IMP
  • File GxP documents
  • Coordinate and collaborate with other COM/CRO´s
  • Ensure high quality level to meet customer and KLIFO requirements

The qualifications of the Clinical Supply Manager:

An ideal candidate is a person committed to creating and delivering 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:

  • 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 Lotte Harreby, Director, at +45 44 222 960 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: 01.08.2021

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