Direct Hire - Associate Director - Clinical Data Management
The Associate Director, Clinical Data Management (A.D. CDM) will be responsible for operational execution of CDM responsibilities for clinical trial programs including but not limited to the oversight of data management activities including Case Report Form (CRF) design, database design, developing Data Management Plan, implementing edit check programs, data entry and query status tracking, and database closure. This role is responsible for tracking important study metrics on data entry, source verification, and query status, and presenting these metrics to a cross-functional team in routine and ad hoc meetings.
- Provide data management leadership, insight, and support to all internal and external projects and clinical trials
- Supports study teams by providing standards for data capture and safety data, assessing the overall quality of data and identifying and escalating key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns
- Manage and provide oversight of data management personnel and activities of staff and vendors
- Provide expertise in the development of CRF/eCRF for clinical trials and its impact into database design/development.
- Assemble data collection requirements from various stakeholders for systems/applications deployed to collect clinical trial data (eCRFs, ePRO, eCOA, etc.)
- Confirm adherence to defined standards, and responsibility for user acceptance testing to ensure high quality deliverables and inspection readiness
- Enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data for internal decision making, regulatory approval and market acceptance.
- Identify new data standards, technologies, and systems and ensure proper implementation
- Develop SOPs to support data management activities
- Provide technical oversight of contracts supporting clinical trial activities
- Provide project management expertise to ensure quality and timely completion of project milestones
- Participate in Clinical Project Teams and support regulatory submission activities
- Contribute to the development and maintenance of a positive team-focused company culture
Education, Experience, and Skills:
- Bachelor’s degree or higher
- Minimum of 10 years experience in leading and supporting data management activities in clinical research for all phases of clinical trials, supporting global trials.
- Experience in managing and leading DM Staff.
- Knowledge and experience with various clinical databases and key technologies (e.g., EDC, eCOA, CTMS, IRT)
- Knowledge of pharmaceutical and regulatory requirements, procedures, and policies, including GCP, ICH, 21 CFR part 11, and other guidance documents and policies related to clinical trials and operations requirements.
- Strong working knowledge of and experience with CDISC standards including SDTM and AdAM dataset specifications and Define-XML.
- Proven experience with system design and implementation.
- Ability to analyze information, review reports, communicate outcomes, and prioritize actions.
- Excellent computer skills; strong verbal and written communication skills.
- Ability to work well in a team environment both as a contributor and leader
- Self-sufficient and able to work with minimal oversight.
- Proficiency in Microsoft Office applications.
- Excellent interpersonal skills and demonstrated ability to establish and maintain professional and productive cross-functional working relationships
- Positive attitude and high personal and ethical standards in achieving corporate goals
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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