Clinical Data Manager
#Data #Management #Clinical
Our partner is looking for a Clinical Data Manager to join its team.
What are your responsibilities?
As a Clinical Data Manager, you will be responsible with leading all aspects of clinical data management associated with data cleaning and quality review processes for assigned projects. You will ensure clinical trial data collected meet the highest standards of data integrity, while meeting timelines and budgets. To be successful in this role, here are your main tasks:
- Mentor, train and supervise junior associates as needed in clinical data management processes and procedures;
- Independently lead several complex trials;
- Lead CRF design, review and validation of clinical database, including management of CRO activities in this area as assigned if required;
- Be responsible for creation of data management plans and other data management documentation as needed;
- Monitor progress and conduct of their respective projects, including all data cleaning and QC activities to ensure all remain on target to project timelines partnering as appropriate with Clinical Operations, Franchise and other BSDM functions;
- Lead, coordinate, facilitate and manage all data management activities from initiation of protocol through database lock, partnering as appropriate with Clinical Operations, Franchise and other BSDM functions for their respective projects;
- Proactively organize and manages ongoing data review throughout study conduct, 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 identification of data handling processes for non-CRF data, including lab data and image handling;
- Work with BSDM leadership, and leadership in Clinical Operations and Franchise to develop project management plans for trial execution including timelines milestones and budgets;
- Lead efforts co-ordinating with Medical Affairs organization to facilitate data coding and safety reviews as needed;
- Independently lead new data management initiatives and contribute towards process improvement, data standards and efficiency gaining initiatives within data management working with the project leader data standards to implement;
- 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 Chief Compliance Officer;
- Perform other related duties as required.
Who are you ?
You have a bachelor’s degree (or equivalent) in the biological sciences, Computer Science or related discipline, with at least 6 years of clinical data management experience in Medical Device or Pharmaceuticals including experience of successful active participation in cross-functional teams. You have functional and technical competencies. Therapeutic area knowledge in at least one of orthopedics, gynecology, cardiovascular, or general surgery. You have excellent verbal and written communication skills. You have knowledge of GCP and regulatory requirements regarding clinical data management documentation and software. You have an experience with Electronic Data Capture (EDC), Medidata RAVE preferred. Knowledge of medical terminology and use of coding dictionaries (MedDRA, WHO Drug).
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply.