Associate Director, Clinical Data Management at Axsome Therapeutics Inc

Warren, New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

BiopharmaceuticalIndustries

Requirements

Leadership experience in clinical data management, including supervisory responsibilities for internal staff and external consultants
Expertise in EDC systems, clinical database management, and data collection instruments (e.g., eCRFs)
Knowledge of regulatory requirements, company SOPs, and compliance standards
Ability to manage multiple tasks, prioritize workload with attention to detail
Understanding of the legal and compliance environment in clinical trials
Experience collaborating cross-functionally with Clinical Operations, biostatisticians, SAS programmers, CRAs, and external vendors (e.g., CROs, clinical laboratories)

Responsibilities

Provide leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases
Develop plans for EDC system processes and other clinical data applications, and assist in defining Sponsor processes and QA/QC documentation
Ensure data collected meets study objectives and company quality standards
Assist in developing and implementing strategic vision for the data management group
Collaborate with CROs to prepare and execute data management plans, and manage projects from start to end
Work with Clinical Operations, biostatisticians, SAS programmers, and others to design and develop data collection instruments
Oversee coding review for adverse events, medical history, concomitant medications, and coordinate medical monitor review
Lead data management activities including database cleaning, data reconciliation, SAE reconciliation, and database lock
Lead development of data management plans, data review plans, supervise database development, and review/process clinical trial data
Prepare and distribute periodic study status reports (e.g., CRF completion, query aging, CPT)
Participate in cross-functional team meetings, communicate project statuses/issues, provide feedback on workflows, and support CRAs
Lead interactions with external vendors on data collection, transmittal, and transfer
Develop and update SOPs, Working Instructions (WI), and Best Practices Documents (BPD)
Participate in clinical review and validation of statistical outputs for final reports
Mentor clinical team members, resolve problems, and provide DM guidance
Drive collaboration with Legal and Compliance team and foster a "ONE Team" approach

Skills

Key technologies and capabilities for this role

Clinical Data ManagementEDCData Management PlansQA/QCSOPsCRO ManagementClinical Databases

Questions & Answers

Common questions about this position

Is this a full-time position?

Yes, this is a full-time employment position.

What is the work location or remote policy for this role?

This information is not specified in the job description.

What are the key responsibilities or skills needed for the Associate Director, Clinical Data Management role?

Key responsibilities include providing leadership and oversight of data management activities, developing EDC system processes, collaborating with CROs on data management plans, overseeing database cleaning and reconciliation, and ensuring data accuracy for clinical trials.

What is the company culture like at PTC Therapeutics?

PTC Therapeutics cultivates an inclusive culture where everyone feels valued, respected, and empowered, welcoming candidates from all backgrounds to foster a strong sense of belonging.

What makes a strong candidate for this Associate Director position?

A strong candidate will have leadership experience in clinical data management, expertise in EDC systems, ability to collaborate cross-functionally with CROs, clinical operations, biostatisticians, and proficiency in overseeing database development, data cleaning, and reconciliation processes.

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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