Johnson & Johnson Careers
Clinical Data Manager
Requisition ID: 1905728791W
The Johnson & Johnson Family of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and non-prescription pharmaceutical products.
Our mission is to care for people around the world by developing innovative products and solutions that are grounded in deep human insights, backed by science that is intuitive, and provide irresistible experiences. To support our Worldwide Research & Development operation, we are building a complex R&D support center in Warsaw, Poland, to be fully integrated in the global R&D footprint and strategy, helping consumers live healthy and vibrant lives.
Clinical Data Manager
Location: Warsaw, Poland
Full time permanent contract
The Clinical Data Manager works closely with the Biostatistics, Clinical and Medical Research groups in all aspects of overseeing the Clinical Research Organization data management OR performing all in-house data management including setting up, managing and completing trials within timelines with the primary goal of ensuring data integrity.
You will have the following areas of responsibilities:
- Ensures all data management activities are conducted in accordance with high ethical and quality standards and all applicable GCP regulations and company procedures
- Acts as subject matter expert for proper data capture based on protocol requirements ensuring the database development, data cleaning, and reporting requirements can be met and are standardized across the program.
- Develops Case Report Form (CRF) according to the protocol with all Study Team members using established standards
- Develops annotated Case Report Forms and CRF completion guidelines
- Develops study database (DB) and edit check specifications
- Develop test scenarios, perform User Acceptance Testing (UAT) and documents results
- Develops, maintains and assures adherence to the Data Management Plan (DMP)
- Coordinates with coder to ensure timely coding occurs
- Performs external data reconciliation with clinical database and reviews data to ensure accuracy and completeness
- Assists in creating data listings/specifications and/or processes data transfers
- Performs study DB lock/unlock
- Assists in reconciliation of all AE/SAE, including queries from Study Manager and Safety team
- Work with vendor(s) in preparation of regulatory submissions and supports interactions with regulatory agencies
Qualifications and experience of the successful candidate:
- Bachelor's degree in a science related field
- A minimum of 3 years' experience in clinical research or clinical data management
- Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
- Experience with Clinical database applications such as Medidata Rave as well as SAS database structure
- Excellent detail orientation, communication skills and an advanced knowledge of English
- Proficiency with JReview and Medidata Rave
- Familiarity with CDASH, SDTM and medical terminology principles in relation to study design.
- Unique opportunity to become part of a global consumer healthcare market leader
- Versatile and fulfilling role in a dynamic and international corporation
- Work in a supportive and highly professional team
- Further opportunities for professional development and career growth
- Motivating financial remuneration & numerous employee benefits
If you are interested in this role and you fulfill the requirements set above, do not hesitate to send us your CV and cover letter in English.
Johnson & Johnson (Poland) Sp. z.o.o. (7815)
Clinical Data Management