eCRF Programmer Location: Poland or Estonia (home-based)
e CRF Programmer (Clinical Data Manager) with the focus on technical tasks is responsible for support of realization of end to end data management (DM) activities related to different aspects of clinical data processing and data management tools and systems development according to Standard Operating Procedures (SOP), project specific plans, ICH Good Clinical Practice (ICH GCP), CDISC (Clinical Data Interchange Standards Consortium) and other applicable regulations and standards. Clinical Data Manager's tasks depend on the process/project/role assigned.
Responsibilities
Provides input to project design, planning and reporting; actively participates in
e CRF design and build, data check and report definition and programming, e CRF maintenance and archiving
Ensures quality, compliance and consistency of all steps of data management activities
Creates manual and automated methods to process clinical trial data in relevant computerized systems (e.g.
EDC/e CRF) to ensure the overall data quality and integrity
Cooperates with Data Management Protocol Lead, Medical Monitor/Medical Reviewer, safety team, Clinical Research Associates, as applicable
and other teams to collect required information and ensure efficient data discrepancy resolution
Creation, maintenance and deactivation of EDC accounts Can take Line Management responsibilities
Effectively communicates with internal and external stakeholders, participates in internal and external team meetings, as needed, client facing.
Develops DM knowledge by participating in internal/external trainings and by self-learning
Shares DM knowledge and expertise with DM team, other departments and Customers, actively promotes
data quality and integrity rules and awareness
Contributes to overall compliance with project and departmental goals and objectives
Identifies, prioritizes, and monitors quality issues to be resolved to maintain compliance
Assists during DM audits, inspections and CAPA processing, as needed
Support development of DM documentation including: SOPs, instructions, Data Management Plans
Supports DM document filing according SOPs and project requirements
Acts as a mentor and trainer for new DM employees (shares knowledge, performs content quality check, provides support in issue solving)
Requirements
Bachelor's/Master's degree or certification in a life-science / healthcare / pharmaceutical related fields
Good understanding of ICH GCP and other ICH/EMA/FDA and local regulations and standards applicable for DM area
At least 2 years of experience in e CRF build in Clinical Data Management, experience with Veeva CDMS is an added bonus
Strong organizational, workload prioritization and time management skills
Excellent communication and interpersonal skills
Able to work independently and within teams, effective in collaborating with others internally and externally
Able to work under pressure in a changing environment with flexibility
Analytical and problem-solving capabilities and skills
Strong customer orientation/focus with strong sense of urgency
Good IT skills (Outlook, Excel, browsing and communicating tools, e.g., Teams)
Advanced verbal and written English language 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 demonstrate how appreciated your talent and your commitment are, KCR is offering you:
1 additional day off for your birthday;
Onboarding process and induction training to develop deep sector knowledge and complex skills;
Latest technology and the most advanced equipment and working tools;
An open culture based on slim processes, in an agile structure with a flat hierarchy and direct access to the Management to share ideas and implement change and continuous improvement;
Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills.
KCR is a clinical development solutions provider creating value for emerging biotechnology organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities. As part of the ICON organization, KCR serves clients globally with key operations hubs in Boston, US, Berlin, Germany, and Warsaw, Poland. KCR’s bespoke approach to service delivery for emerging Biotech companies combined with the global reach and scale of the ICON organization brings a uniquely comprehensive solution to the CRO market. For more information visit www.kcrcro.com.
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