Manager, Clinical Data Management at Axsome Therapeutics

New York, New York, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Jun, 26

Salary

140000.0

Posted On

04 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Data Management Oversight, Vendor Selection, Cost Management, Timeline Management, Cross-Functional Collaboration, Data Listings, SOP Authoring, Data Management Plans, CRF Development, UAT, Data Reconciliation, Database Cleaning, Query Resolution, Mentoring, Project Management, Leadership

Industry

Biotechnology Research

Description

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Manager, Data Management to be responsible for conducting and overseeing all data management aspects for assigned clinical program(s) in compliance with ICH GCP, regulatory guidelines/standards and applicable SOPs. Tasks include collaborating cross-functionally with study teams, providing DM expertise and conducting all data management activities, overseeing vendors, timelines, costs, resources, and key project deliverables. This role is based at Axsome’s HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. Job Responsibilities and Duties include, but are not limited to, the following: Data management oversight of multiple clinical development programs in addition to serving as the lead clinical data manager on designated programs as needed Responsible for data related vendor selection and oversight activities across multiple clinical development programs Oversee the planning and management of Data Management costs and timelines Represent data management function on the clinical and cross-functional team meetings ensuring aligned expectations between all parties, including outside vendors. Ensure achievement of major data management deliverables and milestones in coordination with other functions including Clinical Operations, Safety, Statistics, etc. Responsible for drafting safety and other customized data listings/metrics/reports to drive activities such as medical reviews, clinical reviews and risk-based monitoring Participate and represent data management function in during audits and inspections as requested. Author, review, and revise Standard Operating Procedures (SOPs) Draft/review Data Management Plans, data entry guidelines, data management reports and other documents Lead the development and user acceptance testing of Case Report Forms (CRFs) and edit check specifications per protocol, across the lifecycle of the study Manage external data transfers, reconciliations, and system integrations Lead the process of cleaning databases by performing a review of clinical trial data through EDC or data listings Generate queries to appropriate internal or external personnel (e.g. - investigational sites, vendors, Clinical Research Associates) to resolve problematic data identified during every aspect of the data management process Review responses to queries for appropriateness and resolution to ensure high data quality Train team members on Axsome procedures, study specific handling and management of Data Management systems May also act to supervise and mentor data management staff Ensure archival of all Data Management Trial Master File (TMF) documents Requirements / Qualifications Bachelor’s degree required. Preference to candidates with a scientific background (RN, MS, MD, PharmD, PhD or similar) Minimum of 4 - 7 years data management experience in a biotech/pharmaceutical company or clinical research organization (CRO) Thorough understanding of FDA, GCP and ICH guidelines Strong knowledge of EDC and/or systems design (i.e., Merative Zelta (IBM Clinical), Veeva, Medrio, Rave, etc.), IRT/IWRS and data warehouse technologies as applied to clinical trials Strong working knowledge of (e)CRF design and data management functions/activities as applied to standards library development and maintenance Good working knowledge of CDISC standards and experience implementing standards preferred Advanced knowledge of Excel Good working knowledge of general statistical programming processes and practices. Advanced knowledge of medical terminology, medical coding, laboratory reference ranges, and clinical procedures Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles Experience, Knowledge and Skills Exhibits initiative, strong problem solving and leadership skills Ability to handle multiple programs simultaneously with strong project management capabilities Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities Excellent team player: willingness and ability to fill functional gaps in a small but growing organization Preference to energetic candidates with a desire to think “outside the box” Strong attention to detail and excellent organization skills Strong interpersonal skills and communication skills (both written and oral) Embody a culture of continual improvement and innovation; promote knowledge sharing Salary & Benefits The anticipated salary range for this role is $125,000 - $140,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Responsibilities

The Manager, Data Management will conduct and oversee all data management aspects for assigned clinical programs, ensuring compliance with ICH GCP and regulatory standards. Key duties include collaborating cross-functionally, overseeing vendors, managing timelines and costs, and ensuring the achievement of major data management deliverables and milestones.