Associate Director/Director, Clinical Data Management
Location
Minnesota
Posted
63 days ago
Salary
$200K - $230K / year
Bachelor Degree10 yrs expEnglishGoogle Cloud Platform
Job Description
• Responsible for timelines and quality of CDM deliverables for the assigned studies
• Contributes to technical infrastructure of CDM such as not but limited to development of SOPs, departmental process improvement etc.
• Ensures Data Management Plans are followed through the course of the studies
• Provides feedback and task assignment to meet department and company objectives
• Supports budget and resource planning across assigned projects as required
• Participates in CRO/vendor selection process for outsourced activities
• Directs activities of direct reports as applicable
• Participates in department or cross-functional initiatives as appropriate
• Represents CDM in study team meetings
• Manages or establishes CDM timelines to synchronize deliverables with the overall study timelines
• Proven ability to perform detailed hands-on work as well as high-level strategic task
• Generates and/or reviews/approves study documents (e.g. study protocols, Data Management Plans, Case Report Forms, data transfer specifications, SAE/external data reconciliation plans, coding conventions)
• Oversight of CDM CRO/service providers (e.g. reviewing vendor SOPs, invoices)
• Monitors the progress of all CDM activities for the project to ensure project timelines are met
• Responsible for the accuracy and completeness of the clinical data collected during a clinical trial
• Performs duties as assigned by CDM management/Head of Department.
Job Requirements
- Bachelor’s, or master’s degree (preferred) in Life Sciences, Computer Sciences, Mathematics, or health-related field
- Minimum ten (10) years of DM experience in the pharmaceutical or biotechnology industry
- Three (3) year of staff management desired
- Demonstrated ability to pay attention to details and superior organizational skills
- CRO management experience
- In-depth knowledge of CDM principles, clinical trial process and regulatory requirements
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines
- Proven ability to work both independently and in a team setting
- Experience with web-based Electronic Data Capture (EDC) preferably Medidata Rave, clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug
- Prior oncology/hematology experience highly desirable
- Outstanding organizational skills with the ability to prioritize
- Demonstrated independent and sound decision-making skills; ability to think critically and make decisions in a fast-paced environment
- Continuous improvement mindset; seeking ways to drive innovation and efficiencies throughout the organization
- Flexible and willing to learn; adapting to business and site needs in a dynamic environment
- Maintain a positive, approachable and professional attitude.
Benefits
- medical, dental, vision insurance
- 401(k) match
- PTO
- paid holidays
- annual performance incentive bonus
- new hire equity package
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