Manager, Clinical Data Management
Our client is a Canadian organization in the pharmaceutical and biotechnology research industry. They have asked Bryan Forrest of Lock Search Group to assist them in their search for a Manager of Clinical Data Management.
The Manager, Clinical Data Management will be responsible for the daily activities of the CDM Project Managers and Clinical Data Entry Associates to ensure adherence to timelines, Standard Operating Procedures (SOPs), Good Clinical Data Management Practices (GCDMP) and current industry/regulatory guidelines. The Manager, Clinical Data Management serves as a subject matter expert to provide leadership and expertise in specific CDM activities.
- Collaborate with Project Management, Clinical Operations, Quality Control, Quality Assurance, Scientific Affairs, etc. on data management aspects of projects. Support project teams and staff on achieving client satisfaction through delivery of quality and timely data.
- Provide on-going training/mentoring to assigned personnel on CDM processes, software and activities.
- Manage and provide general assistance to assigned personnel, including hiring personnel, managing personnel matters, and conducting performance evaluations.
- Ensure that standards are observed for database administration, database design, data capture and data quality control.
- Develop and manage Data Management Plans (DMP), Data Entry Guidelines, Data Transfer Plans, and Data Validation Plans for assigned studies.
- Design, build, test and validate CRFs and/or eCRFs and implementation procedures/guidelines.
- Perform data validation activities to ensure data is complete, accurate and of high quality.
- Participate in the implementation of Electronic Data Capture (EDC) techniques including writing specifications, developing study modules and templates, testing and validating.
- Create and or review all clinical data management documents.
- Review and work closely with Director, CDM to address to unresolved data issues; work with external data managers, vendors, and internal team members for resolution.
- Bachelor's degree in scientific discipline
- 2 or more years of data management experience
- Strong operational experience using electronic data capture; familiarity with TrialMaster® database software is considered an asset.
- Experience using data reporting software; familiarity with SAS considered an asset.
- Familiarity with CDISC Study Data Tabulation Model (SDTM).
- Ability to understand and interpret complex clinical study protocols.
- Computer proficiency, especially with MS Windows/Word/Excel and database programs.
- Strong knowledge of GCDMP
- Solid experience of working with edits checks
- CCDM Certified, Considered an asset.
- Ability to work both independently and as part of a team.
- Strong analytical, problem solving and organizational skills.
- Superior attention to detail.
- Able to work under pressure and motivate others.
- Superior communication skills and high proficiency with the English language, both written and spoken as this position interacts with colleagues, clients and vendors.
To apply, please submit a copy of your resume in confidence to Bryan Forrest via the “apply now” button.