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
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