Company

KCR

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Clinical Trial Documentation Manager (PL)

City/voivodeship

Warsaw

Publication

2017-12-04

Company description

KCR is a contract research organization providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries.
The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Trial Execution Consulting (TC) over a broad range of therapeutic areas. 
KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe with hubs located in Boston, U.S., Berlin, Germany, Warsaw, Poland and Kiev, Ukraine. KCR’s geographical locations allow for optimized delivery of trial execution strategies to develop life-changing therapies. For more information visit www.kcrcro.com.
KCR: We see human behind every number
A leading Clinical Research Organisation (CRO), with over 20 years of presence on the international market, operating across 27 countries is seeking to employ experienced Clinical Trial Documentation Manager.
The new incumbent shall take full accountability for managing all aspects of TMF files preparation and the work assigned. Is responsible for direct reports, contractors and functional sources contracting, performance and training.
This is a permanent position based in one of the company’s Operational Hubs in Warsaw (PL).
Location: Warsaw (office-based)
 
The duties associated with the role include:
  • Managing for TMF process improvement initiatives and implementing of new processes. Overseeing and providing assistance in the evaluation of processes to ensure compliance with organizational responsibilities
  • Supervising and accountable for process execution of KPI's for assigned staff and for all TMF related deliverables within expected timelines, including escalation procedures
  • Providing procedural expertise to Clinical Trial Documentation staff members
  • Overseeing status of portfolio of studies in TMF, including identifying documentation related issues within study and develops sound escalation strategy
  • Accountable for TMF quality, performance and compliance with requirements (including ICH GCP, sponsor's SOP, protocol, trial TMF procedures, and contractual obligations) in assigned projects
  • Monitoring and reporting any deviations from expected compliance with TMF timelines
  • Informing on time all clinical staff involved in the assigned studies about modified timelines, changes and other important issues
  • Reviewing all audit responses relative to the assigned team, creates and implements appropriate strategies of risks and issues mitigation
Requirements:
  • College degree (University degree will be a plus) in field of life science or medical science
  • Minimum 2 years of professional experience in field of Clinical Trials in Biotech, Pharmaceutical or CRO company
  • Professional experience in eTMF management while performing duties of CTD Manager, TMF Lead, Project Lead, Project Manager
  • In-depth understanding of entire clinical trial process and documentation requirements, industry standards and guidelines (incl. ICH GCP)
  • Previous experience in managing direct reports (in a project role or a direct Manager role)
  • Previous experience in workflow planning, according to internal standards and timelines for continuous currency of TMF (Trial Master File)
  • Fluent command of English
  • Strong ability to successfully manage a full workload across multiple-projects
  • Escellent in communication skills, negotiations influence
  • Excellent analytical and problem-solving skills
 
At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits
that comply with national regulations and provide the coverage that best meets employee needs.
To show that you are appreciated in our team, while working at KCR you will be provided with: 
  •  3-step onboarding process to enable you fast takeover of duties
  •  Peer Buddy Mentor who will introduce you to the organization
  •  Friendly office space, coffee, tea and sweets
  •  Flexible, remote working options
  •  Time off – additional days of holidays for birthday, leaves of absence
  •  Loyalty bonus for long term cooperation
  •  Employee referral program
  •  Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
  •  Open culture based on our values: knowledge, customer focus, accountability, commitment, tenacity and determination to succeed
  •  Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development
 
If you wish to apply, please submit your CV using the button below.