Job Closed
This listing is no longer active.
Associate Director/Director, Clinical Data Management
Location
Minnesota
Posted
160 days ago
Salary
$200K - $230K / year
Seniority
Senior
Job Description
Associate Director/Director, Clinical Data Management
Celcuity
• 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
Related Guides
Related Categories
Related Job Pages
More Director Jobs
• Prepare executive- and partner-ready presentations, reports, and briefs that clearly communicate recommendations, rationale, and expected outcomes for new programs and product innovations to internal stakeholders and external partners using data and a consultative approach. • Support the design and execution of trial initiatives (MVPs, pilots) to validate new concepts, applying best practices and defined success criteria. • Develop clear partner narratives that support alignment, decision-making, and launch readiness • Conduct partner-specific portfolio analysis to assess performance, market fit and competitive positioning and identity execution opportunities leveraging market research outputs and/or expertise. • Translate product design into actionable go-to-market plans, including business cases, revenue projections, and prioritization frameworks.
Director, Project Methodology – Delivery Enablement
AssistRxSpecialty therapy initiation and patient support company delivering informed access and improved outcomes.
• Responsible for defining, implementing, and continuously improving delivery methodologies, standards, tools, and enablement practices. • Focuses on establishing consistency, scalability, and quality across project execution. • Enables Project Managers, Business Analysts, Strategic Account Managers, and IT delivery leaders through best practices, governance, training, and coaching. • Operates in a fast-paced, dynamic environment requiring close collaboration across functional and leadership levels.
• Own and execute strategy, aligning it with business priorities across ecommerce, retail, operations, finance, and customer experience. • Establish and track key performance indicators (KPIs) along with feedback to inform continuous improvement. • Lead steering committee to review identified opportunities to leverage technology for efficiency, better customer experience, and competitive differentiation. • Lead system integrations with a focus on Shopify, NetSuite, 3PL systems, and customer service platforms. • Ownership of data flow connections and accuracy across platforms. • Ensure data integrity, risk management, and adherence to business standards. • Continuously improve business continuity planning, including cyber security, data security, and disaster recovery. • Deliver highly responsive onsite and remote helpdesk technology support. • Partner with business leaders to identify technological needs and ensure IT initiatives support key business drivers. • Oversee the technology operating budget and technology contract negotiations. • Lead evaluation, negotiation, and managing of vendors. • Build and lead a small but mighty team to support the business and enable reliable and consistent execution. • Use data to drive decision-making and continuous improvement in the tech team. • Manage the intake process of requests spanning software implementation to ad-hoc needs.
Associate Director, Research & Design
FueledWe are a technology consultancy that transforms businesses by generating ideas, building products, & accelerating growth
• Translate research into meaningful product outcomes • Lead research and design decisions across engagements • Build trust and alignment with clients and cross-functional partners • Strengthen Fueled’s design practice through your influence • Step into active, complex work early
