Manager, Clinical Data Management at Axsome Therapeutics Inc

Warren, New Jersey, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Rare DiseasesIndustries

Requirements

Bachelor’s degree in science or related field (such as healthcare)
Minimum of 6 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions
Highly detail oriented while maintaining work efficiency
Able to prioritize

Responsibilities

Provide oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting
Responsible for database development, utilizing EDC system processes and other clinical data applications that allow for internal control of clinical databases
Assist in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC Documentation
Work cross-functionally with internal departments and external resources on Data Management related issues
Support adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate
Ensure the data collected meets the requirements of the study objective and company quality standards
Work closely with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end
Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to develop Case Report Forms (CRFs) to ensure the required information is captured for statistical analysis
Responsible for data management activities, database cleaning and lock activities including developing data management plans, supervising database development, and reviewing and processing clinical trial data to ensure completeness, accuracy, and consistency of clinical trials databases
Prepare and distribute or facilitate distribution of periodic reports of study status including CRF completion status, missing pages, query aging, etc
Participate in cross functional team meetings as requested and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to Clinical Research Associates (CRAs)
Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data
Contribute to SOP development and updates to meet regulatory compliance and operational needs
Participate in clinical review and validation of statistical outputs used in the preparation of final reports
Manage multiple and varied tasks, prioritize workload with attention to detail
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on patients and customers as top priorities
Lead the completion of data management activities to meet project timelines and communicate status to respective team members
Perform other tasks and assignments as needed and specified by management

Skills

Clinical Data Management

EDC Systems

Database Development

CRF Design

Data Cleaning

Database Lock

Data Management Plans

QA/QC

SOPs

Regulatory Compliance

CRO Management

Axsome Therapeutics Inc

Develops therapies for CNS disorders

About Axsome Therapeutics Inc

Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.

New York City, New YorkHeadquarters

2012Year Founded

$430.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Performance Bonus

Company Equity

Risks

Increased competition from companies like Compass Pathways in the CNS market.

Potential delays in AXS-07 launch amid growing market anticipation.

Departure of key personnel like Lori Englebert may impact strategic direction.

Differentiation

Axsome focuses on CNS disorders with limited current treatment options.

AXS-05, an NMDA receptor antagonist, targets major depressive disorder and treatment-resistant depression.

Axsome's balanced portfolio includes both clinical and research stage products.

Upsides

FDA's fast-tracking of CNS treatments could expedite Axsome's drug approvals.

Increased investment in CNS R&D drives innovation, benefiting Axsome's pipeline.

Growing personalized medicine trend offers Axsome opportunities for tailored therapies.

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