Job Closed
This listing is no longer active.
Senior Manager, Clinical Data Management
Location
Minnesota
Posted
157 days ago
Salary
$175K - $192K / year
Seniority
Senior
Job Description
Senior Manager, 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. • 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 • Represents CDM in study team meetings • Manages CDM timelines to coordinate and synchronize deliverables with the overall study timelines • 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, and able to work independently towards the assigned goal • 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
- Excellent verbal/written and interpersonal skills; able to communicate and collaborate effectively with cross-functional teams in a remote setting
- 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
- Ability to work in a team or independently as required
- 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 Manager Jobs
Clinical Manager, LCSW
VyncaCommitted to empowering individuals, their loved ones, and their care teams with solutions delivered in their homes.
• Supervise a team of approximately 10-15 Lead Care Managers • Oversee the creation of Individual Care Plans • Drive the team to meet key performance indicators (KPIs) • Collaborate with Director(s) of Enhanced Care Management to implement changes • Provide direct care management as needed • Additional travel up to 20-25% may be required for training and meetings
Clinical Manager, RN
VyncaCommitted to empowering individuals, their loved ones, and their care teams with solutions delivered in their homes.
• Supervise a team of approximately 10-15 Lead Care Managers • Oversee the creation of Individual Care Plans • Drive the team to meet key performance indicators (KPIs) • Collaborate with the Director(s) of Enhanced Care Management to implement changes and process improvements • Provide direct care management as needed to support organizational goals • Additional travel up to 20-25% for training and meetings
• Provide strategic advice to regional & business lines executives and stakeholders. • Establish company goals, aligned with the regional & business lines executives and stakeholder goals. • Prepare long-term and short-term goals and company objectives for the respective cluster. • Advise and participate in board and advise chairperson on their market and industry. • Plan cost-effective business strategies for the respective cluster. • Develop new ideas based on market, industry and company growth strategy. • Guide and maintain the performance of the company. • Develop and implement strategic operating plans. • Communicate company reports and achievements to the executives, stakeholders, and business partners. • Manage financial investments and business ventures for the respective cluster. • Provide effective leadership while fostering a motivating, high-performing environment for all team members in the respective cluster. • Supervise performance of managers and supervisors within the respective cluster. • Provide the company and team members with a clear vision for future achievements. • Ensure bottom-line profitability for the respective cluster. • Support collections process as needed to facilitate healthy company cash management. • Emphasize, within the cluster, the importance of professional, timely and accurate communication in all forms including, but not limited to, reporting requirements, email responses, and voice message. This applicable to both internal and external. • Make certain any significant points of concern are raised to the appropriate process owner at the executive team level. Again, modeling strong communication skills for all levels. • Develop reporting tools to monitor the ongoing performance of the company. • Lead strategy for new development and clients. • Establish relationships with industry leaders and market experts, airports, government authorities, and customers. • Build the company’s public profile image through networking, conferences, and speaking engagements. • Serve as the public face of the company when required. • Create growth pipelines in collaboration with Business Line Executives to support long-term expansion and profitability. • Work on team member engagement initiatives and support continuous improvement of the GCG corporate brand. • Ensure all operations across all business lines comply with corporate standards, procedures, and customer requirements.
• Analyze fraud activity and develop actionable insights to inform prevention strategies • Design, implement, and optimize fraud rules and alerts for credit card programs • Lead fraud reviews to assess system performance and update strategies as needed • Collaborate with the Fraud Analytics team to develop data-driven rules and reporting • Partner with Fraud Operations to ensure effective management of fraud alerts • Triage fraud events, assess root causes, and implement mitigation actions in real-time • Provide clear and concise fraud trend briefings to leadership • Mentor and manage offshore team members, providing guidance on rule logic, procedures, and fraud trends • Maintain documentation of rule changes, performance tracking, and system configurations


