Company

KCR

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System Specialist

Publication

2021-09-14

Company description

KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR now operates across five regions: North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com.

We see the human behind every number.

KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR now operates across five regions: North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.comWe see human behind every number

System Specialist
 

Location: Poland OR Ukraine (office-home-based)

Systems Specialist is responsible for implementation, maintenance and continued development of (computerized) solutions owned by Central Clinical Operations Services (CCOS) department. Responsible for implementation and continuous improvement of function specific data analysis and data visualization tools and techniques supporting digital oversight within CCOS. Acts as subject matter expert (super user) for all technology solutions used by CCOS team and provides day to day user support. Collaborates with KCR Technology and Innovation (TI) and Data Science and Analytics (DA) departments to assure data and process quality and compliance of solutions to SOPs, GCP and applicable regulations and standards. Collaborates with CCOS functional areas, other TES departments, project teams and TSA Functional Area Lead (FAL) to realize solutions which are well aligned to functional and corporate business requirements. Cooperates with technology vendors, as applicable.

Scope of responsibilities:

  • Assumes the role of solution owner for CCOS owned solutions such as Veeva Clinical CTMS and other solutions as applicable;
  • Works under the environment and according to the processes for digital solutions as defined by Technology and Innovation TE_TI;
  • Develops supplementary procedures and work instructions as required;
  • Fulfills all system administrative activities for Veeva Clinical CTMS, and other solutions as applicable;
  • Provides user support for Veeva Clinical CTMS, and other solutions as applicable;
  • Evaluates and realizes further Veeva Clinical CTMS / other solution needs (continuous system development). This includes KCR customized solutions as well as processing Veeva Releases;
  • Performs computerized systems configurations and validation and prepares associated documentation;
  • Collaborates with technology vendors as applicable;
  • Works closely with TSA FAL and KCR stakeholders to assure CCOS owned solutions continuously meet business requirements;
  • Performs functional level data and ad hoc study level data processing activities including data collection, data transfer, modeling, analysis and visualization (e.g. trending of issues, protocol deviations, queries, recruitment, milestone and KPI reporting);
  • Responsible for creation of system completeness & compliance reporting;
  • Actively participates in discussions around system development, data processing, reporting requirements, infrastructure needs;
  • Acts as mentor for other super users or CCOS team members for Veeva Clinical CTMS / other solutions.

Qualifications:

  • MSc or educational equivalent in computer science, life science or related fields;
  • Minimum 2 years of professional experience preferably in data management, data analysis;
  • Strong computer and analytical skills;
  • Ideally Veeva (or similar) CTMS system experience;
  • Basic knowledge of GCP including a basic understanding of data management/processing requirements applicable for clinical research;
  • Excellent in English and local language, both written and verbal;
  • Good communication and interpersonal skills;
  • Organizational skills;
  • Strong commitment to quality;
  • Ability to effectively manage multiple tasks;
  • Ability to work both individually and collaboratively in teams.
 

At KCR, we put our mission: we see human behind every number into our actions, therefore we offer Our Employees benefits that are being reviewed on a regular basis and to comply with national regulations and to ensure that we provide the coverage that best meets employee needs.

To show that you are appreciated in our team, prove our appreciation, while working at KCR you will be provided all employees with the following:

  • Ability to join fast-growing international CRO company and develop knowledge of clinical trials industry;
  • Efficient Onboarding process to enable you fast takeover of duties;
  • Peer/ Buddy/ Mentor who will introduce you to the organization;
  • Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed;
  • Empowering workspace, offering opportunities to share ideas and influence company services development worldwide;
  • Mentoring and training programs related with in clinical trials, therapeutic areas, soft skills development;
  • Additional days-off for certain special occasions.