Clinical Data Manager

Summary

Join RQM+, a MedTech CRO, as a Clinical Data Manager (CDM) and play a pivotal role in managing the day-to-day operations of data management studies. Collaborate closely with the Manager of Clinical Data Operations and cross-functional project managers. Develop and maintain essential data management documentation, including the Data Management Plan and Edit Check Specifications. Lead data management meetings, create reports, and conduct data reviews. Utilize SAS programming for data listings and ensure data quality through query resolution and reconciliation. Provide oversight to external data providers and maintain EDC user access. This role requires a strong scientific background, experience in data management within a CRO or medical device company, and proficiency in EDC platforms and SAS/SQL programming.

Requirements

• Academic background in Science or Biomedical Engineering
• Previous Data Management experience for a CRO or in industry – preferably for a Medical Device / Diagnostics company
• Good working knowledge of ICH GCP
• Proficiency in using multiple EDC platforms
• Strong communication and organizational skills
• Working knowledge in setting up databases in EDC platforms that may use modules outside of EDC such as Randomization (or RTSM), Labs, ePRO, eConsent, Imaging, and Adjudication amongst others
• Working knowledge of SAS and/or SQL programming
• Experience working in set up, maintenance and locks for multiple projects in parallel
• Working knowledge of MedDRA and WHO DD Coding
• Excellent levels of communication and organizational skills
• Proficiencies in working independently as well as within an overall team structure

Responsibilities

• Primary point of contact for Data Management at a project level, working closely with the Manager of Clinical Data Operations as well as the Cross Functional Project Manager assigned to the trial
• Responsible for the development of the EDC database (including modules outside of EDC) for set up, including the testing of eCRFs and edit checks, user acceptance testing, collection of evidence following testing and overall documentation in the trial master file
• Provides support and training to the wider Data Operations team as well as other internal/external parties as needed e.g. sites, sponsors, third-party vendors
• Responsible for the development and maintenance of the Data Management Plan, Edit Check Specifications, eCRF Completion Guidelines and any other Project Specific Plans related to Data Management throughout the conduct of a trial
• Leads Data Management teleconference calls/meetings and represents Data Management for global calls and meetings during a project
• Creates and maintains specifications for listings and external data reconciliations
• Develops of regular metrics reports and distributes them to RQM+ functional leads and sponsor organizations
• Medical coding (MedDRA, ATC-WHO) if/as needed at a project level
• Comprehensive review of the data entered through ongoing listings and reconciliation activities, resolving all noted issues, querying as needed and tracking any trends in the data
• Oversight of all Data Management trackers and documents to support a proactive approach to data cleaning
• Responsible for reviewing queries and resolving them throughout the trial
• Creates Data Management Listings via SAS programming
• Provides adequate sponsor oversight to data management CRO´s or external data providers (e.g. for ePRO data, laboratory data)
• Ensures EDC user access is reviewed on an ongoing basis aligned with RQM+ SOPs
• Acts as a subject matter expert for the assigned EDC platform needed at a project level
• Supports timelines development and maintenance in set up, maintenance and database lock phases

Benefits

From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals