Job Opportunities in Poland
October 15, 2024
KCR
Warszawa
ECRF Programmer
We see human behind every number
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
Requirements
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:
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.
Our Privacy Policy
Your data will be processed in accordance with KCR Group Privacy Policy. For more details click here: Privacy Policy .
Providing your personal data is voluntary, however, if you do not provide us with the necessary information, we will not be legally allowed to get in touch with you and consider your application. By sending application documents containing your personal data to a wider extent than required by provisions of the applicable laws, you are granting consent for the data to be processed for the purposes of the ongoing recruitment.
If you would like your candidacy also to be considered for future recruitments, please select an additional consent or add the following statement to your application documents: “I agree to the processing of my personal data for any future recruitments conducted by KCR and/or KCR affiliates for a period of up to 3 years”. Such consent may be placed in your CV or electronic correspondence addressed to your potential employer.
You may withdraw any consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.
Your personal data will be shared with KCR and/or KCR affiliate that you are pursuing, and that company will be considered a separate data controller of your personal data. A full list of KCR affiliates is available at: Privacy Policy .
You can contact KCR Group Data Protection Officer at gdpr@kcrcro.com any time with any questions or concerns regarding how your personal data is processed.
KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all.
We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sectors. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.
If you require reasonable accommodations to participate in the application process, please let us know by email: eeo@kcrcro.com. We are committed to ensuring equal opportunity for all applicants and will work to provide reasonable accommodations to support your needs.
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.
Our Privacy Policy
Your data will be processed in accordance with KCR Group Privacy Policy. For more details click here: Privacy Policy .
Providing your personal data is voluntary, however, if you do not provide us with the necessary information, we will not be legally allowed to get in touch with you and consider your application. By sending application documents containing your personal data to a wider extent than required by provisions of the applicable laws, you are granting consent for the data to be processed for the purposes of the ongoing recruitment.
If you would like your candidacy also to be considered for future recruitments, please select an additional consent or add the following statement to your application documents: “I agree to the processing of my personal data for any future recruitments conducted by KCR and/or KCR affiliates for a period of up to 3 years”. Such consent may be placed in your CV or electronic correspondence addressed to your potential employer.
You may withdraw any consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.
Your personal data will be shared with KCR and/or KCR affiliate that you are pursuing, and that company will be considered a separate data controller of your personal data. A full list of KCR affiliates is available at: Privacy Policy .
You can contact KCR Group Data Protection Officer at gdpr@kcrcro.com any time with any questions or concerns regarding how your personal data is processed.
KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all.
We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sectors. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.
If you require reasonable accommodations to participate in the application process, please let us know by email: eeo@kcrcro.com. We are committed to ensuring equal opportunity for all applicants and will work to provide reasonable accommodations to support your needs.
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