Clinmark

Careers

If you are looking for something out of the box in clinical trials and are inspired by diversity, join our enthusiastic team!

19.08.2022 – We would like to announce a vacancy open.

Job title: Quality Assurance Specialist

Location: Poland/Warsaw

The Quality Assurance Specialist is responsible for active contribution to maintaining and developing the Quality Management System and Compliance Plans

Responsibilities:

  •  Manages the review and approval process for policies, standard operating procedures (SOP) and other controlled documents
  •  Prepares and implements QA documents
  •  Documents QA activities and updates related tracking systems
  •  Ensures that standards are observed within the organization: performs internal audits, prepares audit reports, addresses and discusses issues and proposes solutions; makes recommendations for improvement
  •  Identifies training needs and creates training materials
  •  Contributes in development of new standards
  •  Performs quality review of various personal and study documents
  •  May conduct site assessment visits
  •  May lead process improvement initiatives or contribute in such initiatives
  •  Pursues continuing education on new solutions and skills

General Requirements:

  •  Master’s degree preferably in life science
  •  Minimum of 2 years of clinical trial experience
  •  Knowledge of ICH GCP and all applicable regulations
  •  English: professional working proficiency, both written and spoken
  •  Excellent writing skills
  •  Strong analytical-synthetical thinking, problem-solving and decision-making skills
  •  Strong attention to detail
  •  Willingness to continuously learn and develop
  •  Good organizational and communication skills: able to work efficiently, independently and within the team
  •  Ability to work according to timelines

Please send your CV to the email address: rekrutacja@clinmark.eu

16.08.2022 – We would like to announce a vacancy open.

Job title: Safety Specialist

Location: Poland/Warsaw

The Quality Assurance Specialist is responsible for active contribution to maintaining and developing the Quality Management System and Compliance Plans

Main Responsibilities:

  •  Ensures pharmacovigilance processes in assigned clinical studies and supports pharmacovigilance activities across the Company as follows
  •  Registers and handles incoming safety reports, reviews report accuracy and completeness and potential safety issues
  •  Enters the data into the database, codes and prepares narrative summaries
  •  Prepares and performs timely submission of Suspected Unexpected Serious Adverse Reactions (SUSAR) to relevant recipients in accordance with regulatory requirements and standard operating procedure for assigned studies
  •  Maintains and controls safety related documentation flow
  •  Contributes in development of Safety Management Plans/Safety Reporting Plans/SAE Reconciliation Plan
  •  Ensures regulatory and safety compliance throughout the study
  •  Provides safety related training for clinical operational staff or/and sites staff – if needed
  •  Cooperates with Medical Monitor throughout the study
  •  Provides support and expertise within the Organization by responding to ad-hoc queries
  •  Contributes in development and maintenance of safety database and operations
  •  May lead process improvement initiatives or contribute in such initiatives

General Requirements:

  •  Master’s degree preferably in life science
  •  Minimum of 1 year of Pharmacovigilance experience (not negotiable)
  •  Knowledge of ICH GCP and all applicable regulations
  •  English: professional working proficiency, both written and spoken
  •  Strong analytical skills
  •  Good organizational and communication skills: able to work efficiently, independently and within the team
  •  Ability to work according to timelines

Please send your CV to the email address: rekrutacja@clinmark.eu