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.


Gilde Healthcare acquires majority stake in KLIFO

COMPANY ANNOUNCEMENT

Gilde Healthcare acquires majority stake in Danish drug development consultancy KLIFO to support international growth ambitions

 

Northern European integrated drug development consultancy aims to further expand service offering and geographical footprint 

 

May 06, 2021– Utrecht (the Netherlands) and Copenhagen (Denmark) 

Gilde Healthcare, a specialized healthcare investor, and KLIFO A/S, a leading Northern European drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies to advance their drug development projects, today announce that Gilde Healthcare’s Private Equity fund has acquired a majority stake in KLIFO. Gilde Healthcare aims to support KLIFO’s growth in the dynamically developing pharma outsourcing sector.

KLIFO is the largest drug development consultancy in Denmark, with growing operations in Northern Europe. Headquartered in Copenhagen in Medicon Valley, one of Europe’s largest life science clusters, the company has also offices in Sweden, Germany and the Netherlands. KLIFO offers multidisciplinary consulting and operational solutions allowing pharmacos, biotechs and medical device companies to successfully bring their product to market – from clinical research to approval. Its services span all areas of clinical research, clinical operations, clinical trial supply, QA, CMC development, regulatory affairs, and pharmacovigilance. The company has a strong reputation for its deep expertise, customer flexibility and integrated offering.

The acquisition by Gilde Healthcare will build on the company’s success to date and facilitate the next steps in KLIFO’s expansion. This means deepening its service offering and geographic footprint, which will be achieved through organic investments and an active buy and build strategy. KLIFO’s management will continue unchanged, and Alejandra Mørk will continue as CEO of KLIFO and will remain a significant shareholder.

Alejandra Mørk, CEO of KLIFO said: “In the past few years, KLIFO has delivered significant growth, and now is the right time for the company to take the next step on its journey. This strategic investment, along with the support of Gilde’s experienced healthcare professionals, will help sustain our growth ambitions and enable KLIFO to realise its full potential, creating solutions and value for our clients.”

Rafael Natanek, Partner at Gilde Healthcare, added: “We see pharma outsourcing as an attractive segment currently going through a consolidation wave. We are impressed by KLIFO’s highly skilled employees, rapid growth and reputation for competence, flexibility and offering integrated solutions. We look forward working with the management team to help them build on their success, and help the company in its next phase of growth.”

KLIFO was founded in Denmark as a Clinical Research Organisation (CRO) in 1994. In 2008, Alejandra Mørk acquired KLIFO and assumed the role of CEO. Over the next decade, she developed the company into an integrated drug development consultancy supporting all drug development areas. KLIFO has over the years expanded its geographical footprint by establishing an office in Sweden, acquiring the Munich-based Medicomp GmbH and the Dutch company MediServ. Today, KLIFO has offices in Denmark, Sweden, Germany and The Netherlands and employs more than 150 highly skilled employees.

Media contacts: 

LifeSci Advisors

Frank Schwarz – moc.srosivdaicsefil@zrawhcsf
+49 17 26 15 31 60

Gilde Healthcare

Rafael Natanek – moc.erachtlaehedlig@kenatan
+31 61 18 44 63 0

KLIFO

Alejandra Mørk (CEO) – Alejandra.Mork@klifo.com
+45 44 222 910

About KLIFO A/S 

KLIFO is a leading Northern European drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies to advance their drug development projects. KLIFO provides end-to-end expert capabilities, enabling partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement. The company offers multidisciplinary consulting and operational solutions spanning all clinical research areas, clinical trial supply, QA, CMC development, regulatory affairs, pharmacovigilance, and the development of pharmaceutical and biotech products and medical devices. For more information, visit the company’s website at www.klifo.com.

About Gilde Healthcare 

Gilde Healthcare is a specialized healthcare investor managing over €1.4 billion across two fund strategies: Private Equity and Venture & Growth. The Private Equity fund of Gilde Healthcare participates in profitable European lower mid-market healthcare companies with a prime focus on the Benelux and DACH region. The Private Equity fund targets healthcare providers, suppliers of medical products and service providers in the healthcare market. The Venture & Growth of Gilde Healthcare invests in medtech, healthtech and therapeutics in Europe and North America. For more information, visit the company’s website at www.gildehealthcare.com.


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.


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


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


Clincial Trial Assistant München

Clinical Trial Assistant (CTA) für unser Büro in München


KLIFO GmbH suche einen Clinical Trial Assistant (CTA) für unser Büro in München

KLIFO A/S ist ein etabliertes Beratungsunternehmen im Bereich pharmazeutischer Entwicklungen mit Hauptsitz in Dänemark und Niederlassungen in Deutschland, Schweden und den Niederlanden. Wir bieten sowohl Beratung als auch operative Dienste in allen Bereichen der Arzneimittel- und Medizinproduktentwicklung an. Dies beinhaltet Expertise bezüglich Herstellung und Kontrolle von Chemikalien (CMC), Regulatory Affairs, Qualitätssicherung, Arzneimittelüberwachung, Planung und Durchführung von klinischen Studien (Clinical Operations Solutions) sowie Verpackung und Versand von Studienmedikation.

Die deutsche Niederlassung (KLIFO GmbH) benötigt in ihrem Münchner Büro Verstärkung im Bereich Clinical Operations Solutions durch eine(n) Clinical Trial Assistant (CTA, Projektassistenz) für die Durchführung von klinischen Studien. Wir suchen Mitarbeiter, die gerne in einem dynamischen und erfahrenen Team arbeiten und eine positive, proaktive, flexible, und selbstbewusste Persönlichkeit haben. Wir bieten ein flexibles, freies und vertrauensvolles Arbeitsklima mit unterschiedlichen Kunden, spannenden Projekten und kompetenten Kollegen, in denen Ihr Wissen, Ihre Erfahrung und Ihr Beitrag wertvoll sind und hoch geschätzt werden.

Die Position als Clinical Trial Assistant:

Der/die CTA ist verantwortlich für die umfassende Unterstützung des klinischen Teams beim Set-up und der Verwaltung von klinischen Prüfungen an Arzneimitteln oder Medizinprodukten oder nicht- interventionellen Studien:

  • Unterstützung des Projektmanagers und der Clinical Research Associates bei der Dokumentation, Archivierung und Verwaltung von Studien
  • Vorbereitung und Aktualisierung der Projektdatenbank, des Trial Master Files (TMF) und der Prüfarztordner
  • Vorbereitung von Einreichungsdokumenten zur Vorlage bei den zuständigen Behörden und Ethikkommissionen
  • Unterstützung bei der Entwicklung des TMF Plans
  • Verwaltung des Versands/Abholung von Studienmaterialien

Qualifikationen des Clinical Trial Assistant 

  • Wünschenswert: Berufserfahrung als CTA
  • Wünschenswert: Kenntnis der GCP-Richtlinien, der geltenden gesetzlichen Bestimmungen, der medizinischen Terminologie und der Abläufe bei klinischen Studien
  • Gute Kommunikationsfähigkeiten in Deutsch und Englisch (schriftlich und mündlich)
  • Gute Microsoft Office-Kenntnisse
  • Organisatorische Fähigkeiten
  • Genau und präzise mit Liebe zum Detail
  • Sc. im Bereich Biologie oder Pharmazie, medizinische Ausbildung oder vergleichbare Kenntnisse

Zusätzlich zu den oben genannten Qualifikationen ist der/die ideale Kandidat(in) ein kooperativer Teamplayer und dienstleistungsorientiert

We bieten:

  • Arbeit in verschiedenen therapeutischen Bereichen an Aufgaben unterschiedlicher Komplexität
  • Arbeit mit einem heterogenen Kundenstamm (Pharma- oder Biotechunternehmen, Start-ups, Universitäten)
  • Einsatz und Ausbau Ihrer Kompetenzen
  • Arbeit in einer interaktiven, flexiblen und positiven Arbeitsumgebung
  • Ein Team von erfahrenen Kollegen
  • Arbeit in einem Unternehmen mit Sitz in Europa und globaler Reichweite
  • Festanstellung, Teilzeit ist möglich (80%)

Standort:

Diese Position ist office-based in unserer Niederlassungin München

Ansprechpartner::

Für weitere Informationen wenden Sie sich bitte an Dr. Sibylle Gaupels, Team Manager for Clinical Project Management, KLIFO GmbH, unter +49 160 94143935.

Bewerbungen sind zu richten an:  moc.ofilk@ed-boj

Referenz: CTA Office Munich

KLIFO verarbeitet Ihre Bewerbung und alle damit verbundenen personenbezogenen Daten ausschließlich für das konkrete Einstellungsverfahren. Ihre Daten werden als vertrauliche Informationen verarbeitet, vgl. das aktuelle Datenschutzgesetz (GDPR).

View job post as a PDF.


Project Manager - Clinical Operations Solutions, Glostrup, Denmark

Project Manager


KLIFO is looking for a talented and committed Project Manager (PM) 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

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: 14 June, 2021 (although applications are reviewed on an ongoing basis)

View job post as a PDF.