Act as the data management lead for one or more clinical studies including responsibility for all data management and back-end activities from database start-up through database lock
Establish and oversee partnerships with DM vendors and other external partners
Ensure clinical databases and external data files are designed in a standard, accurate, complete, and consistent format to produce datasets that are conducive to analysis and regulatory submission
Oversee data management vendors with respect to key performance indicators, metrics, program level deliverables, and timelines
Review and provide feedback to the clinical team on study documents, including clinical monitoring plans, statistical analysis plans and vendor specifications
Review protocols for all data management activities to ensure data is properly captured via CRF design and data requirements
Coordinate and participate in the review of clinical data, tables/listings/figures (TLF) analysis, and patient profiles for data consistency and accuracy
Ensure that all clinical trials have complete and accurate data and supporting documentation for regulatory submission and data analysis, including raw datasets and annotated CRFs
Ensure data management project documentation is in an audit-ready format
Oversee the building, validation, and maintenance of clinical trial databases in accordance with ICH/GCP guidelines and current regulatory requirements
Oversee the generation of key documents such as data validation specifications, manual data review guidelines, data management plans, data cut plans, CRF completion guidelines, data access plan, data transfer agreements, etc.
Work closely with statistics and programming to ensure high-quality data output including data cleaning/validation, SAS listings review, TLF dry runs, etc.
Develop, track, analyze, and report internal data management performance metrics
Lead computer system development initiatives including database integration, data sharing, access, and storage
Support the setup of other systems such as the safety database and IRT
Contribute to budget/resource planning, re-forecasting and program milestones
Provide leadership, training, and support to data managers
Communicate and escalate project issues involving processes, timelines, resourcing, performance, etc. and establish appropriate courses of action with senior management
Assist in the preparation and support of clinical documentation for IND and NDA submissions as appropriate
Assist with directing the activities of the data management team to complete project deliverables on schedule and per quality standards and requirements from study start-up through archival
Assist with the development of SOPs and specific quality processes and procedures for data management
Ensure data management activities are conducted in accordance with GCP, internal SOPs, and all regulatory requirements
Assist with departmental performance evaluations, goal setting, career development, and growth
Ensure all study specific training is kept up to date and documented for the department

Requirements

Bachelor’s Degree required
Minimum 10 years of clinical data management experience in biotechnology or pharmaceutical industry required
Advanced knowledge of data management processes and systems
Advanced knowledge of setting up Clinical Databases in Medidata Rave
Solid understanding of clinical drug development processes
Must be self-motivated, well-organized, detail-oriented, and have excellent written and verbal communication skills
Possess a willingness and ability to work hands-on and with a sense of urgency, in a fast-paced, entrepreneurial environment
Must be highly resourceful and adaptable to effectively support multiple competing demands and changing priorities
Excellent organizational skills with the ability to manage staff, projects, resources, timelines, and budgets
Travel requirements include travel domestically and/or internationally up to 20%

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data managementclinical databasesdata validationdata cleaningSASCRF designdata analysisperformance metricsdatabase integrationclinical trial databases

Soft Skills

leadershipcommunicationorganizational skillsdetail-orientedself-motivatedadaptabilityresourcefulnessproject managementteam managementproblem-solving

Certifications

Bachelor’s Degree