ECRON ACUNOVA
 
 
 
 

Position

 
   
Senior Clinical Research Associate

Roles and Responsibilities
  • Monitor clinical trials in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines. This will comprise performing pre-study-, initiation-, monitoring- and close out-visits.
  • Communication with investigational sites to improve trail conduct and to strengthen motivation of site staff involved in EA projects
  • Creating study relevant documents for submissions to competent authorities and ethics committees
  • Be up to date with European and local regulatory requirements in clinical trials
  • Participation in national and international project and investigational meetings
Requirements
  • At least 3 years of experience as a CRA
  • Team player with strong communication and collaboration skills
  • Ability to work with investigational sites in the Nordics - Finland
  • Excellent at planning, organising and executing trial activities
  • Ability to prioritize tasks, while keeping attention to important details
  • Study of natural science (biology, medicine, pharmacy or nursing) or equivalent
  • Willingness to travel
Location
  • Home based in Finland

Senior Clinical Research Associate

Roles and Responsibilities
  • Monitor clinical trials in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines. This will comprise performing pre-study-, initiation-, monitoring- and close out-visits.
  • Communication with investigational sites to improve trail conduct and to strengthen motivation of site staff involved in EA projects
  • Creating study relevant documents for submissions to competent authorities and ethics committees
  • Be up to date with European and local regulatory requirements in clinical trials
  • Participation in national and international project and investigational meetings
Requirements
  • At least 3 years of experience as a CRA
  • Team player with strong communication and collaboration skills
  • Ability to work with investigational sites in Germany
  • Excellent at planning, organising and executing trial activities
  • Ability to prioritize tasks, while keeping attention to important details
  • Study of natural science (biology, medicine, pharmacy or nursing) or equivalent
  • Willingness to travel
Location
  • Frankfurt

Head of Pharmacovigilance (m/f)

Roles and Responsibilities
  • Functionally responsible for the Pharmacovigilance Department   including clinical trial and post-marketing PV, all operational and compliance aspects, budget planning, personnel development / training needs, processes and systems of the department, as well as profitability in terms of client acquisition (support of BD and proposal teams), percentage of billable hours of department; participation in and consultation on preparation and presentation of proposals
  • Management of contracted services within the area of responsibility on a project basis regarding quality, timelines, costs etc., in alignment with the operational project management
  • Managing interfaces and processes for cross-office and cross-continental collaboration within the area of responsibility of the department
  • Medical project management, medical planning, medical review, scientific advice, teaching and medical writing according to SOPs
Requirements
  • Medicine Doctor
  • Special degree (certificate) in a clinical specialty or other relevant field of medicine, and/or substantial practical experience in a clinical setting
  • Regulatory procedures and pharmacovigilance / drug safety experience necessary, both during clinical trials and post-marketing
  • Substantial practical experience in drug development desired excellent command of written and spoken English necessary
  • Good command of written and spoken German required
  • Experience in the pharmaceutical industry
Location
  • Frankfurt am Main

Clinical Research Associate Russia

Roles and Responsibilities
  • To maintain awareness of local regulatory requirements, and to conduct studies in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines
  • Conduct as well as pre-/Post-processing of pre-study-, initiation-, monitoring- and close out-visits
  • Creating study relevant documents
  • Communication with investigational sites Participation in national/international project and investigational meetings
Requirements
  • Experience as a CRA
  • Study of natural science (biology, chemistry), medicine, pharmacy or qualification as medical documentalist, health care specialist, paramedic professional
  • Willingness to travel extensively
  • The ability of a good communication, dedication, reliability and a talent for organising are required
Location
  • Office based/home office

Project Manager

Roles and Responsibilities
  • Management of national and multinational clinical trials including
      • Planning of clinical trials as regards contents, regulatory compliance and administrative and logistic aspects
      • Interface management
      • Management and co-ordination of CRAs:
        • Coordination of national or multinational multicentre trials
        • Supervision of GCP compliance
        • Supervision of trial conduct, as regards monitoring, safety aspects, timelines, and trial budget
      • Prospective and timely troubleshooting
  • Continuous communication during the project with the sponsors and internally at EA
  • Cooperation with data management, biometrics, medical writing, medical services and pharmacovigilance, quality assurance and other functions at EA or vendors
  • Participating in and responding to in-house inspections and audits in collaboration with EA’s QA Department
Requirements
  • At least 3 years of experience in planning, conducting, supervising and evaluating clinical trials in accordance with GCP – preferably from another CRO. 
  • Analytical mind-set and a strong talent for planning, organising and executing trial activities
  • Excellent communication, organisational skills and team leading skills
  • Ability to quickly understand medical issues within different therapeutics areas
  • Good understanding of clinical research methodologies
  • Very good command of written and spoken English. Command of other one or more European language will be an asset
  • Understanding of regulatory procedures and guidelines in Europe
  • Study of natural science (biology, medicine, pharmacy or nursing) or equivalent – e.g. Bachelor, Master or Ph.D. level
Location
  • Frankfurt

Senior Clinical Research Associate

Roles and Responsibilities
  • Monitor clinical trials in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines. This will comprise performing pre-study-, initiation-, monitoring- and close out-visits.
  • Communication with investigational sites to improve trail conduct and to strengthen motivation of site staff involved in EA projects
  • Creating study relevant documents for submissions to competent authorities and ethics committees
  • Be up to date with European and local regulatory requirements in clinical trials
  • Participation in national and international project and investigational meetings
Requirements
  • At least 5 years of experience as a CRA
  • Team player with strong communication and collaboration skills
  • Ability to work with investigational sites in Denmark, Norway and Sweden
  • Excellent at planning, organising and executing trial activities
  • Ability to prioritize tasks, while keeping attention to important details
  • Study of natural science (biology, medicine, pharmacy or nursing) or equivalent
  • Willingness to travel
Location
  • Home based in Italy

Senior Clinical Research Associate

Roles and Responsibilities
  • Monitor clinical trials in accordance with SOPs, guidelines and ICH Good Clinical Practice guidelines. This will comprise performing pre-study-, initiation-, monitoring- and close out-visits.
  • Communication with investigational sites to improve trail conduct and to strengthen motivation of site staff involved in EA projects
  • Creating study relevant documents for submissions to competent authorities and ethics committees
  • Be up to date with European and local regulatory requirements in clinical trials
  • Participation in national and international project and investigational meetings
Requirements
  • At least 5 years of experience as a CRA
  • Team player with strong communication and collaboration skills
  • Ability to work with investigational sites in Denmark, Norway and Sweden
  • Excellent at planning, organising and executing trial activities
  • Ability to prioritize tasks, while keeping attention to important details
  • Study of natural science (biology, medicine, pharmacy or nursing) or equivalent
  • Willingness to travel
Location
  • Home based in Czech Republic

Global Head of Biostatistics for Clinical Research

Roles and Responsibilities
  • Global co-ordination and lead of the statistical group
  • Biometric activities with regard to study protocols, sample size calculations, and data validation
  • Preparation of statistical analysis plan
  • Programming of statistical analyses, tables, figures, and listings
  • Statistical reporting
  • Preparation of data review and data review meeting
  • Active support to improve standards and processes
  • Communication with biometrician/statistician of sponsor
Requirements
  • Degree in statistics or mathematics with statistics as subsidiary subject
  • Sound knowledge of biostatistics
  • Understanding of medical matters
  • Experience in clinical trials of more than five years
  • Sound knowledge of statistical program packages (SAS)
  • Excellent command of written and spoken English
  • For (non-native German: excellent command of written and spoken German)
Location
  • Frankfurt am Main

BD Executive

Roles and Responsibilities
  • Buildup of business relationships as well as maintenance of existing business relations
  • Acquisition of new clients
  • Hunting activities by telephone, mailing activities, advertising, client meetings
  • Preparation of business presentations and participation at client meetings as well as bid-defense meetings
  • Participation in negotiations with clients
  • Organisation and participation in national and international exhibitions and congresses
  • Account Management duties
Requirements
  • At least 5 years’ experience in Clinical Research / GCP within CRO, pharmaceutical or biotech industry
  • 3 yearsxperience in the field of business development is preferred
  • Study of medicine, veterinary medicine, or natural science is preferred
  • Ability to learn quickly, show initiative and work as an effective team player
  • Open-minded, enthusiastic and motivated personality with excellent communication and presentation skills
  • Very good command of written and spoken German and English (good negotiation skills)
Location
  • Office-based in Frankfurt or home-based Europe

Clinical Investigator

Roles and Responsibilities
  • Medical Screening of Healthy Volunteers ( History, Physical Examination, Laboratory tests , ECG and X-ray)
  • Determination of Volunteer eligibility for Clinical Study as per Inclusion/exclusion Criteria of protocol
  • Monitoring, Reporting and Management of Adverse Events/ Serious Adverse Events occurring during clinical study
  • Maintenance of Emergency Drugs List and ICU set-up
Requirements
  • 1 years or more general medical practice. Freshers can also be considered
  • Candidates with experience in ICU and those who have undergone training in Basic Life Support/ Advanced Cardiovascular Life support will be preferred.
  • Experience in Clinical Research/ Bioequivalence Studies is desirable
  • Knowledge of kannada language is desirable
Location
  • Mangalore
 
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Join our team
Position
Senior Clinical Research Associate
Senior Clinical Research Associate
Head of Pharmacovigilance
Clinical Research Associate Russia
Project Manager
Senior Clinical Research Associate
Senior Clinical Research Associate
Global Head of Biostatistics for Clinical Research
BD Executive
Clinical Investigator
 
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For career opportunities in India/South East Asia please contact
Mr Noel Rajan and email your resume to
careers-asia@ecronacunova.com
For career opportunities in Europe/USA, please contact
Ms Cornelia Germroth and email your resume to
careers-europe@ecronacunova.com
 
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