Senior Clinical Data Manager

Job purpose

Reporting to the Director of Biometrics, the Senior Clinical Data Manager (CDM) will primarily oversee the data management activities at Blue Earth Diagnostics. They will provide subject matter expertise in regard to database design, data transfers, vendor interactions and timelines. This includes authoring and/or reviewing documents in relation to database design, interim analyses and database locks. The CDM also serves as the point of contact for Data Management (DM) related activities with vendors, vendor selection/bid defense meetings and developing companywide DM standards library of Case Report Forms (CRF) and edit check specifications.

Main Responsibilities, Activities, Duties and Tasks

• Fulfil the role of lead data manager on all clinical trial project projects as part of the biometrics team.
• Contribute to CRF Design and Edit Checks Development for Electronic Data Capture (EDC) platforms (e.g., Medidata RAVE)
• Reviewing of DM documentation including Data Management Plans, Data Transfer Specifications, Edit Check Specifications and support User Acceptance Testing (UAT)
• Actively participate in DM activities including cross-functional meetings and vendor management calls
• Involved in developing Standards library for CRFs and Edit checks in relation to CDISC standards and Study Data Tabulation Model (SDTM) mapping for future trials
• Provide support in data review and data reconciliation, and monitor the work performed by Clinical Research Organization (CRO) on data cleaning and data reconciliation until the end of the trial
• Support the data review/cleaning in clinical studies e.g. creating internal checks using SAS or other programming software
• Review of study protocols, Statistical Analysis Plans, Tables/Listings/Figures, and CSRs.
• Creation/review of standard operating procedures related to data management.
• Provide internal data management training to other functions within Blue Earth Diagnostics as required.
• Input into and management of clinical study data management budgets for upcoming and ongoing clinical trials
• Other duties as determined by business needs.

Education

BSc (Hons) Life Sciences or a related field

Professional Experience, Knowledge & Technical Skills

• Extensive experience as a data manager at a pharmaceutical/biotechnology company or contract research organization
• Experience working closely with outsourced study vendors
• Good understanding of SAS programming concepts or other computing software
• Good understanding of CDASH and CDISC Standards
• Good understanding of the drug development process
• Proficient understanding of DM processes and documentation
• Knowledge of Good Clinical Practice (GCP) regulations/requirements
• Oncology and diagnostic imaging experience

Soft Skills –Company Values & Behaviours

• Ability to work in a high paced team environment, meet deadlines, & prioritize work on multiple projects
• Ability to accurately estimate effort required for project related data management activities.
• Strong coaching, facilitation, and organizational skills; team player. Experience and skills with cross-functional and highly matrixed organizations.
• Excellent oral & written communication skills. Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.
• Strong coaching, facilitation, and organizational skills