Aktualnie prowadzone rekrutacje

With offices in Berlin, Warsaw and Prague, KCR Placement is an international boutique provider of ‘fit for purpose’ resourcing solutions for a wide array of functions, including expert, managerial and senior executive ones. We specialize in finding the right talents for Pharmaceutical, Biotech, Medical Device companies and Contract Research Organizations across Europe. 

We're onboarding best-in-class candidates, so give us a chance to meet you!

Current Vacancy Highlights:

Manages all aspects of Trial Master Files preparation and the work of assigned Clinical Trial Documentation Services team according to Standard Operating Procedures, GCP Guidelines, contractual obligation and applicable law. Is responsible for the direct reports, contractors, and functional sources contracting, training, and performance. Works independently, under supervision of the Head of Clinical Trial Documentation Services.
Clinical Trial Documentation Manager

Detailed Job Duties and Responsibilities

Manages all aspects of Clinical Trial Documentation Team:
  • Has overall line management and TMF oversight responsibility for assigned employees
  • Responsible for TMF process improvement initiatives and implementation of new processes. Oversees and provides assistance in the evaluation of processes to ensure compliance with organizational responsibilities
  • Serves as an expert in eCMS and TMF
  • Accountable for TMF quality, performance and compliance with requirements (incl. ICH GCP and contractual obligations) in assigned projects
  • Responsible for appropriate management and resolution of performance issues
  • Participates in teleconferences and meetings with Sponsor or/and study staff in support as needed
  • Responsible and accountable for process execution of KPI`s for assigned staff and for all TMF related deliverables within expected timelines, including escalation procedures
  • Provides procedural expertise to Clinical Trial Documentation staff members
  • Maintains good working relationships with internal and external clients to ensure opportunities for new business
  • Interacts collaboratively with other internal teams who have identified responsibility for ownership of functional area documentation within KCR
  • Oversees status of portfolio of studies in TMF; informs Head of Clinical Trial Documentation Services of any deviations from expected compliance with TMF timelines; identifies documentation related issues within study and develops sound escalation strategy
  • Participates in sponsor audits and Regulatory Authority inspections; coordinates documentation preparation to sponsor’s audits and inspections; ensures continuous up to date documentation in anticipation of audits and inspections
  • Reviews all audit responses relative to the assigned team
  • Ensures best practices are implemented and lessons learned are communicated to Clinical Trial Documentation Team
  • Responsible for proper communication and reporting within timelines
  • Performs other duties as assigned by Head of Clinical Trial Documentation Services

Oversees overall aspects of people management
  • Provides leadership for the development and implementation of new training programs and improvement of current programs for managers and assigned staff
  • Responsible for resource management
  • Responsible for detailed performance review and management of assigned direct reports including setting objectives and conducting annual appraisal
  • Informs the Head of Clinical Trial Documentation Services of any problems arising during the cooperation with assigned staff
  • Responsible for initiation and supporting execution of recruitment process for the respective area
  • Verifies the state of knowledge of assigned staff with respect to the conducted clinical trial and associated documentation requirements (sponsor’s SOP, protocol, trial TMF procedures, project-specific contractual obligations)
  • Oversees and verifies executions of tasks assigned to staff in the scope of assigned studies
  • Informs on time all clinical staff involved in the assigned studies about modified timelines, changes and other important issues
  • Prepares yearly vacations plan and yearly plan of staffing needs
  • Ensures that all assigned staff have been provided with adequate materials and equipment
  • Submits an application to Head of Clinical Trial Documentation Services regarding salary, bonus, special benefit, promotion or dismissal of assigned staff
  • Motivates and engages staff, with positive and/or developmental feedback and coaching
  • Assesses training plans and assists with training and development of new employees

People Management and People Supervising Responsibilities
  • Clinical Trial Documentation Associates
  • Junior Clinical Trial Documentation Associates

Education / Qualifications / Skills Requirements
  • University/college degree (life science or medical degree preferred)
  • Minimum of two (2) years of relevant or clinical trials experience in biotech, Pharmaceutical or CRO
  • Strong ability to manage and motivate direct reports
  • In-depth understanding of industry standards, applicable guidelines (incl. ICH GCP), local law (if needed) and applicable FDA/EMA regulations knowledge
  • Deep knowledge of the entire clinical trial process and documentation requirements
  • Ability to work independently and efficiently according to SOPs, GCP
  • Ability to guide and plan assignments consistent with Clinical Documentation timelines for continuous currency of Trial Master File
  • Strong ability to successfully manage a full workload across multiple-projects
  • Excellent in communication skills, negotiation, influence
  • Excellent analytical and problem-solving skills
  • Computer competency
  • Fluent in English, both written and verbal

  • Available for travel including overnight stays as necessary, consistent with project needs and office location
We’re onboarding “best in class” candidates, so give us a chance to meet you!
NOTE: When applying please kindly enclose the following statement:

"I hereby give my consent to the processing of my personal data included in the CV provided by me (within the scope beyond the contractual authorization), by KCR Placement Sp z o.o. on behalf of its clients with its seat in Warsaw (6 Postepu str, 02-676 Warsaw) as the data administrator, for the purposes related to the recruitment process conducted by the said entity. This consent also includes the processing of my personal data within the above scope in any future recruitment processes, unless the aim of such processing changes."