Clinical Data Manager Consultant

Job Title: Clinical Data Management / Contractor

Job Number: 33608

Location: Remote, 

Job Description

• Liaise with various internal and external groups (Clinical Development Clinical Operations, Statistics, Statistical Programming, Pharmacovigilance, and external vendors including CROs) for the implementation of data management activities needed for clinical studies across all phases of clinical drug development.
• Provide clinical data management oversight of clinical studies including but not limited to project management, vendor management, coordination of internal reviews, and approval of DM deliverables and timelines
• Ensure clinical data capture, systems, and processes in place for accurate, consistent, high quality, and complete data for regulatory submission
• Primary author / approver for CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, Data Management Plans, and third-party vendor data specifications and reconciliation
• Oversee clinical database design, UAT and production cycles, ensuring that meets the highest quality standards
• Lead, facilitate, and conduct internal DM and cross functional review of clinical data, medical coding, and SAE reconciliation

Responsibilities

•This position will serve as an essential link between CDM Solutions team and CDM portfolio and study leads
•Support standardized processes and procedures for clinical data collection, cleaning, and reporting
•Participate in process improvement and training initiatives within CDM and across functions
•Oversee compliance with SOPs, regulatory requirements, Good Clinical Data Management best practices and other applicable industry standards
•Maintain awareness of details CDM initiatives and track action items for Clinical Data Management team to review and report accordingly
•Lead and support the development, review and implementation of processes, policies, SOPs, and associated documents affecting CDM
•Support CDM solution team, identifies and evaluates fundamental issues, providing strategy and direction for major functional areas and lead the effort for improvement and optimization from CDM
•Support standards data governance process, partner with portfolio leads to ensure portfolio specific requirements are met
•Work with CDM solution team to lead or participate in department initiatives, cross-functional working groups and process improvement activities
•Assist DM leads in response to CDM process and quality related questions
•Support Inspection Readiness activities, build documentation for SOP Deviations and other Quality Events that occur
•Execute trainings to data managers when preparing for an audit, inspection, or handling an issue related to process quality/compliance
•Continuously monitor and evaluate data management processes to identify areas for improvement and implement best practices
•Align efforts with the cross-portfolio clinical data management team to ensure appropriate issue resolution of data quality issues from process and system level
•Support CDM solutions team and, partner with cross function process owners to prepare training documents specific to CDM team
•Support the adoption of technology improvements and tools clinical data management processes
•Support CDM solution team in translating business strategy and function needs into business requirements
•Provide vendor management oversight, ensuring data management activities for clinical trials are efficiently managed within assigned research program(s)
•Study level coordination and hands on CDM tasks, including clinical data review
•Oversees development of, edit check specifications, CRF Completion Guidelines or Data Entry Guidelines, Data Management Plan, Data Review Guidelines, SAE Reconciliation Plan, to ensure compliance with SOPs and DM process documents

Required Skills

Bachelor’s degree in Natural / life sciences, scientific, or bioinformatics / computer science background (university degree) and former experience in a CRO/ biotechnology/ pharmaceutical company

Experience working in the pharmaceutical industry or other clinical research setting with clinical trials

Understanding of US and global regulations and guidelines (e.g., FDA, EMA, MHRA, ICH) applicable to clinical development;

Must have relevant technical skills, DM process understanding and CRO oversight, Strong QC skills, and broad understanding of regulatory requirements for pharmaceutical/biotechnology industry

Fluent in English (written and spoken)

Minimum of five (5) years of clinical research experience

Equivalent education, experience and/or training may be substituted for the experience requirement

The ideal candidate will be detail oriented, have excellent organizational skills, be proficient in computer applications (Word, Excel, Oncore™), possess excellent communication and interpersonal skills, be able to maximize resources and be resourceful