For one of our clients, we are lookinf for a Clinical Data Manager
Reporting to the Head of Clinical Data Management, the selected candidate will collaborate with the team with the objective of making clinical data, coming from different sites, available for the analysis and decisions of our Clinical Science and Medical professionals.
- Lead and coordinate all data management activities from study start up through database lock and perform vendor oversight for outsourced activities.
- Lead the development and revision of Data Management Documentation, such as Case Report Form (pCRF or eCRF), Study Validation Plan (SVP), Data Management Plan (DMP), Data Validation Plan (DVP), Data Management Report (DMR), EDC specifications, reports, throughout the lifecycle of the project and ensures compliance with established SOPs, GCP and international regulatory guidelines.
- Develop Data Transfer Agreement (DTA) between XXXXXX and vendors and reconcile data within the Clinical Database.
- Develop test scripts and execution logs for User Acceptance Testing (UAT), coordinate UAT of eCRF build and validation documents.
- Provide Clinical Data Management support to Clinical Operations, Project Management, Drug Safety, Clinical Science and Biostatistics team.
- Provide input and review clinical documents such as Protocols, Clinical Study Reports, Laboratory Analysis Plan and Statistical Analysis Plan.
- Provide training on study trial tools and create user guides.
- Assist in definition and design of CDISC compliant data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review.
- Coordinate the archiving / filing in TMF of study databases and CDM related documents.
- Assist in reconciling AE/SAE data in Safety database and/or other Data
- Collaborate with IT and Clinical Database Developers (DBD) to address Clinical application requests and/or changes to Clinical database systems, support development and implementation of new technologies.
- Participate in Clinical Trial Meetings, conference calls and/or meetings with vendors.
- Develop, revise and maintain standard operating procedures and working instructions
- Coaching and mentoring of other CDM staff and newcomers
Skills and competencies
- Strong Clinical Data Management experience is required, gained in pharmaceutical industry, CRO or Life Science related industry.
- Ability to coordinate the data management activities with the project team, prioritize multiple tasks and manage time efficiently.
- Detail oriented, solution oriented with excellent organizational and communication skills.
- Knowledge of CDISC standards.
- Knowledge of RDBMS, clinical database applications, SQL, SAS, Excel, Access, VBA.
- Fluent in English is required.
- Working knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
- Understanding of the research environment and good knowledge of global regulatory requirements such as ICH GCP and CFR 21 part 11