Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Data Analytics & Computational SciencesJob Sub Function:
Clinical Data ManagementJob Category:
ProfessionalAll Job Posting Locations:
Antwerp, Antwerp, Belgium, Hamburg, Germany, Issy-les-Moulineaux, France, Warsaw, Masovian, PolandJob Description:
SENIOR CLINICAL DATA MANAGER, NEUROVASCULAR
Location: Belgium, France, Germany or Poland
(However applications open to the entire EMEA region)
Contract: full-time
(MedTech)
(Data Analytics & Computational Sciences)
(Clinical Data Management)
The Senior Clinical Data Manager will be responsible for all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects with minimal supervision. S/he ensures clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. Reporting to the Manager, Data Management.
DUTIES & RESPONSIBILITIES
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Support CRF design, review and validation of clinical database, including supporting management of CRO activities in this area if required;
- Have the ability to support a number of moderate complexity / complex trials with minimal supervision;
- Be responsible for creation of data management plans and other data management documentation as needed with minimal oversight;
- Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines;
- Be responsible for coordinating, facilitating and participating in all data management activities from initiation of protocol through database lock with minimal oversight, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects;
- Be responsible for participating in ongoing data review throughout the conduct of the study, including being responsible for the correction of errors and discrepancies management for the life of a project;
- Proactively identify and address issues that may impact the quality of the data, deliverables or timelines;
- Be responsible for handling of non-CRF data, including lab data and image handling;
- Be responsible for co-ordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed;
- Contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with data management leadership as needed;
- Be responsible for ensuring all clinical data management documentation is stored and archived in a timely and compliant manner;
- Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times;
- Diligently participate in compliance program-related activities as denoted by the supervisor or our Chief Compliance Officer;
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs other duties assigned as needed
EXPERIENCE AND EDUCATION
- A Bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline, with at least 4 years of clinical data management experience in Medical Device or Pharmaceuticals.
- Experience of supporting trials with minimal supervision.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
- Functional and Technical Competencies:
- Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery.
- Proficient in computer technology used in an office environment (Microsoft Word, Excel, etc).
- Strong verbal and written communication skills.
- Knowledge of GCP and regulatory requirements regarding clinical data management documentation and software.
- Experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug)
The anticipated base pay range for this position is
3 675 EUR gross/monthly to 5 922 EUR gross/monthly in France
5 208 EUR gross/monthly to 8 155 EUR gross/monthly in Germany
10 083 PLN gross/monthly to 16 195 PLN gross/monthly in Poland
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
Required Skills:
Preferred Skills:
Advanced Analytics, Biostatistics, Business Behavior, Clinical Data Management, Clinical Operations, Communication, Cross-Functional Collaboration, Database Applications, Data Privacy Standards, Data Savvy, Good Clinical Practice (GCP), Organizing, Problem Solving, Report Writing, Standard Operating Procedure (SOP), Systems AnalysisThe anticipated base pay range for this position is:
€60,000.00 - €96,255.00Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
