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

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

01.06.2022 – We would like to announce a vacancy open.

Job title:          Clinical Project Leader (CPL)

Location:         Poland/Warsaw

Main Responsibilities:

  • Management and oversight of study execution within the company
  • Organization of local project meetings, tasks delegation and execution
  • Involvement in escalation and resolution of issues raised during the course of the study
  • Review of site visit reports, comments and support for CRAs
  • Supervision of all kind of contact with EC and RA, submission package review
  • Supervision of study sites management, support for sites contracts negotiation
  • Study budget management
  • Study progress periodical reporting to Executive Board/HCO
  • Co-visits (training and supervisory) with CRAs and completion of co-visit report

General Requirements

  • University/college degree preferably in life science
  • Knowledge of ICH GCP Guidelines and all applicable regulations
  • Communicative English, both written and spoken
  • Strong analytical skills
  • At least 2 years of experience as CRA
  • Experience in Lead Monitor or Project Manager role would be appreciated
  • Ability to work efficiently, independently and within the team
  • Good organizational and communication skills
  • Willing to travel

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

Job title:          CRA Manager

Location:         Poland/Warsaw

Main Responsibilities:

  • Manage an international team of CRAs to ensure monitoring activities are performed as per the requirements (e.g. ICH GCPs, local regulatory requirements, etc.),
  • Provide guidance to PM in the supervision of CRAs
  • Oversee monitoring metrics and key performance indicators
  • Evaluate and manage CRA staffing needs, resources, performance issues, and timelines, in coordination with the PM
  • Communicate regularly on projects status to the HCO, PMs, and the Sponsor to ensure project goals are met
  • Collaborate with other CRA managers as required to achieve department goals
  • Proactively identify and mitigate/escalate, resolve monitoring issues, as appropriate
  • Responsible for recruitment/selection of CRAs
  • Accountable for site audit report reply and the implementation of/ follow-up on corrective actions/preventive actions
  • May perform CRA assessment visits, as required
  • May review Monitoring Visit reports, as required
  • May perform Objectives/Appraisals process, as required  
  • Lead development/review of study related documents
  • Lead process improvement initiatives

General Requirements

  • University/college degree preferably in health related fields such as Medical, Pharmacy or in Life Science or its international equivalent
  • A minimum of 3 years of experience as a CRA, in combination with a supervisory role
  • Strong ICH-GCPs knowledge
  • Demonstrated effectiveness in mentoring/leadership/supervisory ability is an advantage
  • Excellent team player with team building skills
  • Ability to prioritize multiple tasks and achieve project timelines
  • Excellent knowledge of medical terminology and clinical monitoring process
  • Effective time management in order to meet daily metrics or team objectives
  • Must work both independently and in a team environment
  • Excellent interpersonal and conflict resolution skills
  • Effective verbal and written communication skills with strong attention to detail
  • Ability to work in a multi-cultural environment
  • Ability to perform well in a constantly changing environment
  • Ability to travel up to 30% on average

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

14.01.2022 – We would like to announce a vacancy open.

Job title:          Data Manager (DM)

Location:         Poland/Warsaw

Main Responsibilities:

  • The Data Manager independently oversees data management operations for an assigned therapeutic area, program or project.
  • The Data Manager ensures that projects are completed in accordance with the applicable regulatory requirements as well as the established budget, timelines, and sponsor specifications.
  • Ensures appropriate use of project management and data management tools and serves as a resource to data management staff in troubleshooting project-related issues.
  • Develops complex project plans, such as integration of multiple data sources or migration of data between systems.
  • Ensures quality and timeliness of data management deliverables.
  • Data Manager directly provides and/or oversee project-specific initiation and orientation, as necessary.
  • Data Manager is a coach, support and mentor for department staff.

General Requirements

  • Bachelors degree mandatory; Master’s degree is a plus
  • Minimum of 2 years of directly related data management experience

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

Job title:          Clinical Project Leader (CPL)

Location:         Poland/Warsaw

Main Responsibilities:

  • Management and oversight of study execution within the company
  • Local project meetings organizing, tasks delegation and execution
  • Involvement in escalation and resolution of issues raised during the course of the study
  • Review of site visit reports, comments and support for CRAs
  • Supervision of all kind of contact with EC and RA, submission package review
  • Supervision of study sites management, support for sites contracts negotiation
  • Study budget management
  • Study progress periodical reporting to Executive Board/HCO
  • Co-visits (training and supervisory) with CRAs and completion of co-visit report

General Requirements:

  • University/college degree preferably in life science
  • Knowledge of ICH GCP Guidelines and all applicable regulations
  • Good English, both written and spoken
  • Strong analytical skills
  • At least 2 years of experience as CRA
  • Experience in Lead Monitor or Project Manager role would be appreciated
  • Ability to work efficiently, independently and within the team
  • Good organizational and communication skills
  • Willing to travel

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

Job title:          Clinical Trial Assistant (CTA)

Location:         Poland/Warsaw

Main Responsibilities:

  • Provides continuous support to CRAs and Clinical Project Leaders with the day-to-day administrations of assigned clinical studies
  • Prepares and distributes Investigator Site Files, Pharmacy Site Files or other files needed for Site Initiation Visits
  • Assists CRA with adaptation of study specific forms for Investigator Site Files (ISFs)
  • Prepares and maintains Trial Master File (TMF) according to Clinmark or Sponsor SOPs
  • Reviews study files periodically for accuracy and completeness
  • Prepares and maintains QC/Inventory Checklists for the TMF and ISFs
  • Assists CRA with QC of TMF
  • Provides cross-functional support for other ongoing activities including inspection readiness preparations
  • Responsible for study documentation and filing, as well as timeline tracking and reporting
  • Provides organizational and logistical support for compliance-related activities, including study management, site management, monitoring oversight and trial files management

General Requirements:

  • University/college degree preferably in life science
  • Knowledge of ICH GCP Guidelines and all applicable regulations
  • Good English, both written and spoken
  • Effective verbal and written communication skills in a cross functional environment
  • Sound knowledge of medical terminology and clinical monitoring process
  • Ability to deal with rapid change
  • Proactively owns and drives assigned tasks to completion
  • Excellent customer focus with demonstrated management of customer expectations
  • Ability to work independently and to effectively prioritize tasks
  • Ability to manage multiple tasks with attention to details
  • Ability to establish and maintain effective working relationships with co-workers, managers, investigational site personnel and local vendors
  • Computer literacy, proficiency in Microsoft Office

For consideration, please send resume to rekrutacja@clinmark.eu

Job title:          Business Development Assistant (BDA)

Location:         Poland/Warsaw

Main Responsibilities:

  • Build prospect lists by researching leads through online tools
  • Carry out cold calls and send strategic emails to build a strong first impression of prospects.
  • Evaluate lead potential by asking questions and following a consultative sales strategy, qualifying them, and scheduling demonstrations to be done by operational team members.
  • Maintain reliable and up-to – date client pipeline and documents to ensure that information is exchanged around the team and other team members can help sign the agreements that you have implemented.
  • Attend sales meetings and interact with other departments.
  • Conducts diligent and accurate follow up on all inquiries within the expected timeline.
  • Present and sell company services to new and existing customers.

General Requirements:

  • University/college degree preferably in life science.
  • Great English, both written and spoken. Knowledge of other languages would be an asset.
  • 1-2 years of experience in a similar role, with a sales track record.
  • Proven record of lead nurturing, lead generation, and appointment setting.
  • Adaptable and professional; working individually or as a member of a team.
  • Excellent verbal and written communication skills.
  • Highly organized and attentive to detail.
  • Able to work in a fast-paced environment and handling challenging workload.
  • Highly motivated with a strong desire to succeed.
  • Strong Internet research skills.
  • Proficient MS Office skills.

For consideration, please send resume to rekrutacja@clinmark.eu

Explore our career areas and see how your skills can change the world of medical innovation.

Other open positions:

  • Business Development Assistant
  • Office Assistant/Receptionist
  • Clinical Trial Assistant
  • Clinical Research Associate
  • Clinical Project Specialist

We look forward to receiving your applications. If there are no current vacancies, please feel free to submit an open application.

Please send your CV at rekrutacja@clinmark.eu