Category: Scientific & Clinical
Director, Clinical Data Management
Location: Princeton NJ on site daily
Duration: Permanent with full benefits
- A couple years experience as a Associate Director or Director in Data Management
- At least ten years’ experience in a pharmaceutical, biotech or clinical research setting with experience managing Data Management staff (2 direct reports) and clinical trials.
- Experience working on Phase I-IV clinical trials within the pharmaceutical and / or biotechnology industry.
- Experience managing CRO sand timelines, able to build out dept (Creating SOPs,and processes for dept)
- Small Pharma or Start-Up experience
- Practical experience in protocol review, CRF design, clinical database build, User Acceptance,medical review, database lock and review of TLFs
- Knowledge of SAS, Data Structure, SDTMmapping and ADaM datasets
- Excellent time management skills
- Strong knowledge of full clinical development life cycle
- Experience in both small biotech and large pharmaceutical or CRO is a plus
Data management software: InForm
- Responsible for leading the data management functions and coordinating activities related to the planning, execution, collection, and cleaning of clinical data.
- This position has oversight of activities leading to the final delivery of clean clinical data for the purpose of clinical study reports, publications, and regulatory submissions.
- This position may have direct supervisory responsibilities for internal staff or external consultants. This position will take a leadership role in defining processes and procedures for maintaining clinical data and the associated QA/QC documentation.
- Develop and implement strategic vision for data management (DM) group
- Develop and implement standardized Data Management Process and Procedures for
- consistency across programs and organization
- Prepare and monitor department budget
- Plan and develop staffing allocations including assessment of candidates, recommend hiring
- Evaluate vendors in support of development needs (DM, IWRS, EDC, Coding, etc.)
- Manage the clinical data managers within the organization, mentor staff, assess performance
- Responsible for all Data Management timelines and deliverables from study start up to final clinical study report
- Vendor Oversight to ensure that the process, procedures, data deliveries, timelines and study documentation created are of high quality, compliant with the study requirements, SOPs and GCPs.
- Coordinate with biostatisticians, data managers, CRAs, programmers, etc., to expedite and assure the flow of data between study sites, the data management group.
- Coordinate the data cleaning, delivery, distribution of all data needed for periodic reports,DSMB, DSUR, Regulatory postings, medical/safetyreview, blind data review, database lock, TLFs, final clinical study report (CSR)
- Participate in cross functional team meetings as requested.
- Communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.
- Develop and update SOP's associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.
- Take a leadership role in the review and query of clinical data. This includes the criticalreview of data-populated tables, figures, and listings as part of the database clean-up and prior to database lock.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.