Are you a seasoned Clinical Data Manager and open to a new challenge in a dynamic medical device environment ? Are you looking for a broad position offering the opportunity to build on and further develop your experience and skills ? Then don't hesitate and apply !
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 this individual will:
- 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;
- Performs other related duties as required.
FUNCTIONAL & 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).
- Cultivate relationships with key internal stakeholders to ensure projects remain on target to project timelines.
- Develop knowledge of therapeutic areas within the Franchises.
- Active participation as data management representative on project teams to ensure deliverables are met.
- Ensure projects are delivered on time, within budget and in compliance to regulations and SOPs.
EDUCATION & EXPERIENCE REQUIREMENTS:
- 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.
- Existing right to work in Europe required
- A balanced salary package based on your capabilities and experience, including extra legal benefits
Vacancy number: 20268