Lead CRA (LCRA) - Clinical Operations Solutions, Glostrup, Denmark

Lead CRA


KLIFO is looking for a talented and committed Lead CRA (LCRA) based in Denmark

KLIFO is expanding our office in Denmark and wants to engage a Lead CRA 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 Lead CRA:

The Lead CRA (LCRA) is responsible for monitoring activities of trials across several sites and/or countries including pro-active site management and oversight:

  • Performing feasibility and assessing suitability of clinical trial sites
  • Participate in the Risk Based Quality Management (RBQM) process with focus on the monitoring strategy
  • Development and review of Informed Consent Forms
  • Applications to Ethics Committee and review of Regulatory Submission Packages as applicable
  • Review and approval of Regulatory Green Light (RGL packages)
  • Development of study specific plans in cooperation with PM and sponsor
  • Review and approval of monitoring reports from other CRAs
  • Ensure adherence to agreed monitoring visit schedule across all sites
  • Oversight of SDV status, data entry status and data quality standards across sites. Initiate root cause analysis if not on track and escalate to PM
  • Coordinate data cleaning activities in cooperation with data management
  • Plan and lead CRA meetings to ensure knowledge sharing and common monitoring practice / implementation of study specific processes across sites
  • Training and supervision of CRAs in trial specific processes and procedures. Perform co-monitoring visits
  • Day-to-day management of central lab as applicable

The qualifications of the Lead CRA:

  • BSc. in the life sciences field or related discipline and a minimum of 3-4- years in a similar position in the pharmaceutical industry/Biotech/CRO
  • Knowledge of GCP guidelines, applicable regulatory requirements, medical terminology and clinical trial processes
  • Willingness to travel
  • Excellent communication skills (written and verbal) in English as well as in native language (if other than English)
  • Experience with multi-country and multi-centre trials
  • Ability to translate client’s needs into solid deliveries
  • Ability to work independently without supervision of a colleague within the group
  • Ability to supervise and coach non-senior personnel within the group

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 in Denmark, Germany, Sweden and The Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Stine Larsen, Director, KLIFO A/S at +45 4422 2959

Applications should be sent to: 

moc.ofilk@boj marked Lead CRA. 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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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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Clinical Research Director - Clinical Trials, Denmark

Clinical Research Director – Glostrup, Denmark


KLIFO is expanding and wants to engage an additional Clinical Research Director into a dynamic and experienced team within Clinical Operations Solutions. The people we engage like to work in a consulting environment and have a positive, proactive, flexible, self-driven and self-confident personality. We can offer a trustful working climate with a co-operative, experienced and competent team and exciting customers and projects where your personality, knowledge, capability and contribution are valuable and appreciated

The position as Clinical Research Director:

The Clinical Research Director of Clinical Operations Solutions (COS) is the functional leader that should conduct clear and effective leadership and ensure that the operational strategy supports that all clinical trial activities are conducted in a way that fits well into the overall strategy for internal processes and collaborations internally as well as with external customers. Important aspects are:

  • Strong leadership of COS team and managing staff in accordance with organization’s policies and applicable regulations.
  • Evaluating the workload and the quality of the clinical work product.
  • Resource planning and prioritization of department tasks to ensure optimal and flexible use of resources.
  • Ensure and demonstrate development of COS employees as team and individuals.
  • Attract new highly qualified and promising employees to expand KLIFO’s business.
  • Retention of valid qualified employees.
  • Responsible for ensuring that the COS employees understand and meet the needs of the individual client and for a well-functioning working relation.
  • Demonstrate and promote business awareness, i.e. monitor that work is performed in accordance to agreed contracts with clients.
  • Function as robust ambassador for KLIFO’s role model of working with employees and clients.
  • Be self-driven in finding and improving organizational and procedural gaps and weaknesses.

The qualifications of the Clinical Research Director:

  • Sc. in the life sciences field and at least 10 years’ experience in the pharmaceutical industry/BioTech/CRO.
  • Extensive knowledge of GCP guidelines, applicable regulatory requirements, medical terminology, clinical trial processes and drug development.
  • Excellent communication skills (written and verbal), excellent in English.
  • Excellent computer skills.
  • Strong leadership and organizational skills.
  • Strong self-understanding.
  • Ability to motivate employees and teams.
  • Good managerial and interpersonal skills as well as professional authority.
  • Ability to listen and seek understanding of other points of view in both team and client relationships.
  • Solution oriented.

In addition to the above-mentioned qualifications, the ideal candidate is action orientated, able to make decisions and has strong planning and task management skills.

We offer:

  • Leadership of highly compentent and motivated people.
  • Taking part of a dynamic and well collaborating leadership team in an expansive and exciting company.
  • 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 in both Denmark, Germany, Sweden and The Netherlands. This position will be located at our office in Glostrup, Denmark.

Contact:

For more information, please contact Klas Rådberg, Vice President, KLIFO A/S at +45 9363 1358

Applications should be sent to:

moc.ofilk@boj marked “Clinical Research 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).

Further information about KLIFO can be found at www.klifo.com

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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.


Director GCP Quality Assurance

Director of GCP Quality Assurance

 


KLIFO is looking for a Director of GCP Quality Assurance

This is a new position with the aim of strengthening the support to Clinical Operations and PV across KLIFO’s geographic units.

The Director GCP QA will be responsible for quality assurance of KLIFO’s GCP covered activities and be part of the team offering GCP QA Solutions to KLIFO’s clients in Europe and in the US.

 We are extending our clinical study activities and the organisation engaged in clinical studies. Therefore we want to further develop our GCP QA organisation and have initiated a process of updating our clinical SOP system.

Further, we experience an increasing number of requests of GCP related consulting services.

We are looking for a skilled QA GCP Director to develop roadmaps and lead the development and implementation of an updated clinical SOP-system as well as leading our GCP/GPV related activities in KLIFO.

The key activities are:

  • Lead the GCP QA team with direct reports in Denmark and functional reports from other parts of KLIFO
  • Develop roadmaps and lead implementation of SOP harmonization project across KLIFO offices
  • Further development of the Quality Management System within the Clinical Operations and the Pharmacovigilance areas
  • Risk Assessments and approval of Vendor/System Qualifications
  • Lead of GCP and GPV audits and inspections for KLIFO
  • Participate in KLIFO projects as QA representative

In addition, the activities will include consulting tasks as

  • QA consulting to Clients , e.g. QMS GAP analysis and inspection readiness
  • Development of QMS system
  • Audits on behalf of clients

The qualifications of the Director of GCP Quality

You are MSc in the life science field, and have at least 7 years’ of QA experience within GCP in the pharmaceutical industry and you are a trained lead auditor.

advantage but is not mandatory.

You must be flexible, service-minded, a team player and interested in working in a consultant environment.

Some travelling should be expected.

Fluent in one of the Scandinavian languages and in English.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established and 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 both Denmark, Germany and Sweden. This position can be located at our office in Denmark.

Contact:
For more information, please contact Alejandra Mørk, CEO, +45 40 631 163 or Anne Ploug Jørgensen, Senior Director QA, +45 44 222 982.

Applications should be sent to: moc.ofilk@boj marked Director of GCP Quality Assurance
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: Recruitment interviews will be held on an ongoing basis.

View job post as a PDF.

KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany, and Sweden. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement. For more information, visit www.klifo.com


QA Specialist/Senior QA Specialist

Director of GCP Quality Assurance

 


KLIFO is looking for a Director of GCP Quality Assurance

This is a new position with the aim of strengthening the support to Clinical Operations and PV across KLIFO’s geographic units.

The Director GCP QA will be responsible for quality assurance of KLIFO’s GCP covered activities and be part of the team offering GCP QA Solutions to KLIFO’s clients in Europe and in the US.

 We are extending our clinical study activities and the organisation engaged in clinical studies. Therefore we want to further develop our GCP QA organisation and have initiated a process of updating our clinical SOP system.

Further, we experience an increasing number of requests of GCP related consulting services.

We are looking for a skilled QA GCP Director to develop roadmaps and lead the development and implementation of an updated clinical SOP-system as well as leading our GCP/GPV related activities in KLIFO.

The key activities are:

  • Lead the GCP QA team with direct reports in Denmark and functional reports from other parts of KLIFO
  • Develop roadmaps and lead implementation of SOP harmonization project across KLIFO offices
  • Further development of the Quality Management System within the Clinical Operations and the Pharmacovigilance areas
  • Risk Assessments and approval of Vendor/System Qualifications
  • Lead of GCP and GPV audits and inspections for KLIFO
  • Participate in KLIFO projects as QA representative

In addition, the activities will include consulting tasks as

  • QA consulting to Clients , e.g. QMS GAP analysis and inspection readiness
  • Development of QMS system
  • Audits on behalf of clients

The qualifications of the Director of GCP Quality

You are MSc in the life science field, and have at least 7 years’ of QA experience within GCP in the pharmaceutical industry and you are a trained lead auditor.

advantage but is not mandatory.

You must be flexible, service-minded, a team player and interested in working in a consultant environment.

Some travelling should be expected.

Fluent in one of the Scandinavian languages and in English.

We offer:

  • Work within different therapeutic areas and with tasks of varying complexity
  • Work with a heterogeneous client pool (pharmaceutical companies, established and 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 both Denmark, Germany and Sweden. This position can be located at our office in Denmark.

Contact:
For more information, please contact Alejandra Mørk, CEO, +45 40 631 163 or Anne Ploug Jørgensen, Senior Director QA, +45 44 222 982.

Applications should be sent to: moc.ofilk@boj marked Director of GCP Quality Assurance
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: Recruitment interviews will be held on an ongoing basis.

View job post as a PDF.

KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany, and Sweden. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement. For more information, visit www.klifo.com


Director - Data Management and Biostatistics, 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.


Project Manager - Clinical Operations Solutions, Lund, Sweden

Project Manager


KLIFO is looking for a talented and committed Project Manager based in Sweden

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 in both Denmark, Germany and Sweden. This position will be located at our office in Lund, Sweden.

Contact:

For more information, please contact Sara Hedman, Managing Director, KLIFO AB at +46 708 708 084

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:
08 November 2020 (although applications are reviewed on an ongoing basis)

View job post as a PDF.


Medical Writers - Clinical Operations Solutions, Lund, Sweden

Medical Writers


KLIFO is looking for talented and committed Medical Writers based in Sweden

KLIFO is expanding our office in Sweden and wants to engage Medical Writers into a dynamic and experienced team within Clinical Operations Solutions. The areas covered by KLIFO also include Clinical Trial Supply Solutions, Pharmacovigilance Solutions, Regulatory Affairs Solutions, CMC Development Solutions and Drug Development Counselling.

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 clinical study protocols
  • Generation of clinical study reports
  • Generation of IBs and other documents related to the conduct of clinical trials and non-interventional studies
  • Generation of patient facing material, 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

The qualifications of the Medical Writer:

  • 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 Clincial 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 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

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.

Location:

KLIFO has offices in both Denmark, Germany and Sweden. This position will be located at our office in Lund, Sweden.

Contact:

For more information, please contact Sara Hedman, Managing Director, KLIFO AB at +46 708 708 084

Applications should be sent to: moc.ofilk@boj marked MW.

Deadline: 

08 November 2020 (although applications are reviewed on an ongoing basis)

KLIFO is an established and integrated drug development consultancy with offices in Denmark, Germany and Sweden. We provide end-to-end expert capabilities, enabling our partners to maximise opportunity, mitigate risks, drive innovation and achieve efficient project advancement.

View job post as a PDF.


Director - Data Management and Biostatistics, Munich, Germany

Director – Data Management and Biostatistics


KLIFO GmbH is looking for a skilled and experienced
Director Data Management and Biostatistics

KLIFO A/S is a drug development consultancy with significant experience in partnering with biotech and pharmaceutical companies in Europe, US and Asia to advance their drug development projects. We offer multi-disciplinary consulting and operational solutions spanning all areas of regulatory affairs, clinical research, clinical trial supply, CMC development, pharmacovigilance, and the development of pharmaceutical and biotech products and medical devices. KLIFO A/S currently has offices in Denmark, Sweden and Germany.

KLIFO now wants to appoint a Director Data Management and Biostatistics (DirDM-BioStats) into a dynamic and experienced team within our Clinical Operations Solutions team in Germany. The person we are looking for is a skilled and experienced Data Scientist and highly motivated professional and talented team leader with a positive, proactive, flexible and self-confident personality.

The position as Director DM-BioStats:

The DirDM-BioStats is the functional leader of the Data Management and Biostatistics department in our Munich office. The successful candidate will be responsible for defining the department business strategy, ensure highest quality deliverables, its continuous professional development and the alignment with overall corporate business and development needs and goals.

The main responsibilities of the successful candidate will be:

1) Business strategy and delivery:

  • Develop and drive the strategy and objectives of the Data Management & Biostatistics department.
  • Evaluation and implementation of suitable and cost effective systems and technical solutions that best support our business needs.
  • Leading role in the development and continuous update of processes, procedures and harmonizations.
  • Accountable for the group’s budget, scheduling, and performance standards (KPIs).
  • Driving continuous operational improvement, optimization of workflows and quality initiatives.
  • Ensuring best quality of deliverables according to highest standards and client expectations.

2) Functional leadership:

  • Ensure continuous professional development of the departmental services and capabilities.
  • Organizational alignment with actual and future business demand and needs.
  • Continuous development of department training plans incl. individual development of employees.
  • Effective and proactive resource management.
  • Act as a role model for, demonstrate and promote business awareness within the department.
  • Support of program and project level operational activities as applicable.

3) Business development and sales:

  • Supporting the Senior Director COS and corporate business development in development and execution of business development and sales strategies.
  • Contribution to the development of client proposals and in bid defense meetings.
  • Contribution to DM+Biostats related sales activities/initiatives.
  • Support the generation of repeat business by ensuring compliance with delivery on existing contracts.

The qualifications of the Director DM-BioStats:

The Director DM-BioStats should possess the following qualifications:

  • Proven knowledge of tasks and deliverables within the biostatistics and data management fields.
  • Awareness of current state of the art statistical and/or data management processes & procedures.
  • Knowledge of GCP and other applicable regulatory guidelines and requirements.
  • Profound knowledge of medical, data management and biostatistical terminology clinical trial processes and drug development.
  • Strong leadership and organizational skills including ability to motivate employees and teams.
  • Sc. in the life sciences field and at least 5-7 years’ experience in the pharmaceutical / BioTech / CRO industry.
  • Excellent verbal and written communication skills.
  • Fluent in English and German (spoken and written).
  • Good collaboration capabilities.
  • Like working in an international environment.

We offer:

We can offer a dynamic, inspiring and trustful working environment within a highly motivated team and a dynamic and growing international company with a diverse and exciting customer portfolio across all categories.

Contact:

For more information, please contact Dr. Nils Piwon, Senior Director Clinical Operations Solutions,
KLIFO GmbH at  +49 89 895286-0.

Applications should be sent to: moc.ofilk@boj marked “Director Data Management and Biostatistics”.

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.