Clinical Data Management Specialist II

We see human behind every number

Clinical Data Management Specialist II

Location: Poland or Estonia (home-based) 

Clinical Data Management Specialist II 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), MedDRA, CDISC (Clinical Data Interchange Standards Consortium) and other applicable regulations and standards. Clinical Data Management Specialist II’s tasks depend on the process/project/role assigned.

Detailed Job Duties and Responsibilities

• Receives and processes clinical trial data of trial subjects, medicinal products and medical devices
according to applicable regulatory requirements, SOPs, Data Management Plans and guidelines
• Performs data management activities including data entry, data receipt, review, analysis, encoding,
reconciliation and discrepancy resolution
• Ensures quality, compliance and consistency of all steps of data management activities
• Processes clinical trial data using manual and automated methods in relevant computerized systems (e.g.
EDC/eCRF) to ensure the overall data quality and integrity
• Cooperates with Medical Monitor/Medical Reviewer, safety team, Clinical Research Associates
and other teams to collect required information and ensure efficient data discrepancy resolution
• Performs accurate coding of medical terms and medications reported in clinical trials using industry-wide
standards (e.g. MedDRA); Interacts with Medical Monitors and other team members to ensure timely review
and delivery of coded data
• Provides input to project design, planning and reporting; supports
coordination of DM process set-up, CRF set-up, collector design, edit data check, report
definition, requirement documentation and testing
• 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)
• Effectively communicates with internal and external stakeholders, participates in internal and external team
meetings
• 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

Education / Qualifications / Skills 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 1 year of experience in Clinical Data Management
• 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 biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people. For more information visit www.kcrcro.com.

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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.