Manager, Clinical Data Management

Axsome Therapeutics•New York, NY

4h•$125,000 - $140,000•Onsite

About The Position

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.

Requirements

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
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

Nice To Haves

Preference to candidates with a scientific background (RN, MS, MD, PharmD, PhD or similar)
Good working knowledge of CDISC standards and experience implementing standards preferred
Preference to energetic candidates with a desire to think “outside the box”

Responsibilities

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